DermatomyositisPhase 1NCT00112385
A Pilot Study of Etanercept in Dermatomyositis
A Phase 1 study testing Etanercept in people with Dermatomyositis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of the study is to obtain preliminary data regarding the safety and tolerability of etanercept in DM. In addition, we will use the study to assess the variability, reliability, and responsiveness of the core set of outcome measures recommended by IMACS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study subjects must meet the following criteria:
- Meet the diagnostic criteria for DM (a-c; a,b,d; or a,c,d)
- Subjects must have symmetric proximal greater than distal weakness
- Characteristic DM rash consisting of any or all of the following: heliotrope, shawl sign, V-sign, Gottron's sign, Gottron's papules, periungual telangiectasias
- Laboratory evidence of myopathy with at least one of the following: an elevated serum CK or aldolase level, myositis-specific antibody, electromyography (EMG) demonstrating myopathic features (e.g., muscle membrane instability, myopathic units, or early recruitment), or an abnormal skeletal muscle MRI showing diffuse or patchy edema within the muscles.
- A muscle biopsy will be optional if the patient fulfills criteria a-c. The subject must demonstrate symmetric proximal weakness (criteria a) for entry into the study. If the subject does not have a definite rash (criteria b) or laboratory evidence of a myopathy (criteria c), a muscle biopsy will be required. The muscle biopsy must demonstrate one of the following: perifascicular atrophy, expression of MHC 1 on perifascicular muscle fibers, MAC deposition on small blood vessels, tubuloreticular inclusions in endothelial cells on EM, or MXA expression on muscle fibers of blood vessels
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- Newly diagnosed subjects should be able to walk independently 30 feet (cane, walkers, orthoses allowed). However, subjects with refractory dermatomyositis may be non-ambulatory.
- Age > 18 years
- Patients must not use topical skin ointments for treatment of the dermatological manifestations as it will interfere with skin assessment.
- Men and women of childbearing age must be willing to use a method of birth control.
- Able to give informed consent
- Subject or designee must have the ability to self-inject investigational product or have a care giver at home who can administer subcutaneous injections
Who cannot join
- The presence of any of the following excludes subject participation in the study:
- Presence of any one of the following medical conditions: active infection, uncontrolled diabetes mellitus, MI, CVA or TIA within 3 months of screening visit, symptomatic cardiomyopathy (congestive heart failure), symptomatic coronary artery disease, uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, systemic lupus erythematosus (SLE), cancer (other than basal cell skin cancer) less than 5 years previously, HIV or other immunosuppressing disease, positive PPD test or any history of mycobacterial disease, chronic hepatitis B or hepatitis C, history of multiple sclerosis, transverse myelitis, optic neuritis, chronic inflammatory demyelinating neuropathy, epilepsy, or other chronic serious medical illnesses
- Presence of any of the following on routine blood screening: WBC<3000, Platelets < 100,000, hematocrit < 30%, BUN > 30 mg %, symptomatic liver disease with serum albumin < 3 G/DL, PT or PTT > upper range of control values
- Forced Vital Capacity < 50% of predicted
- History of non-compliance with other therapies
- Any prior or concurrent cyclophosphamide, or current use of any immunosuppressive agent besides methotrexate (e.g., azathioprine, mycophenolate, or cyclosporine)
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- Coexistence of other neuromuscular disease that may complicate interpretation of the results of the study
- Drug or alcohol abuse within last 3 months
- Pregnancy or breast feeding
- Juvenile DM
- Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept
- Use of a live vaccine 90 days prior to, or during this study.
- Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
- Concurrent sulfasalazine therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of the study is to obtain preliminary data regarding the safety and tolerability of etanercept in DM. In addition, we will use the study to assess the variability, reliability, and responsiveness of the core set of outcome measures recommended by IMACS. The study will be performed under the aegis of the Muscle Study Group (MSG), consisting of experienced investigators with an avid interest in myopathies. The ultimate goal of this pilot study will be to obtain necessary, prerequisite information important in designing future therapeutic trials of etanercept and other agents in patients with DM. The specific aims of the study are:
Aim 1: To preliminarily assess the safety and tolerability of etanercept in patients with DM.
Read more
Aim 2: To assess the safety and tolerability of prednisone in the dosing schedule we propose to use.
Aim 3: To evaluate outcome measures recommended by IMACS and assess their variability, reliability, and responsiveness in order to facilitate the design of future therapeutic trials in the inflammatory myopathies.
Read the detailed description
Dermatomyositis (DM) is one of the major subtypes of idiopathic inflammatory myopathy. Prednisone is the initial treatment of choice in most patients with DM. However, because of the high rate of patients with disabling weakness despite treatment with prednisone, the long-term side effects of prednisone, and the many side effects associated with other second-line immunosuppressive agents (e.g., methotrexate, azathioprine), better treatment options are needed. There is evidence that tumor necrosis factor-a (TNF-a) plays a role in the pathogenesis of DM. Thus, etanercept, which blocks TNF-a, is a logical drug to assess in DM. Etanercept has been associated with a number of side effects including an increased risk of infection, inducing other autoimmune diseases, and perhaps cancer. These risks may be further enhanced in DM in which the frequency of other autoimmune disorders (e.g., connective tissue disease) and malignancy are already increased.
The goal of this pilot study will be to assess the safety and tolerability of etanercept in DM.We will perform a double-blind, placebo-controlled pilot study of etanercept in 40 patients with DM randomized in a 3:1 ratio to receive etanercept or placebo. All newly diagnosed and untreated patients will be started on a standard dose of prednisone and tapering schedule. Refractory patients who have been or are currently being treated with prednisone, IVIG, or methotrexate can also participate. Subjects will be followed for 1 year and we will assess various outcome variables recommended by the The International Myositis Assessment Clinical Study Group (IMACS). The primary aim of the study is to preliminarily assess the safety and tolerability of etanercept in patients with DM. We hypothesize that etanercept will be safe and well tolerated in this population. The second aim is to assess the safety and tolerability of prednisone in the dosing schedule we propose to use. We hypothesize that most patients will be able to tolerate the reduction of the prednisone dosage but most will not be able to be completely weaned off the medication. We believe we will find a relationship between prednisone dosage and its related side effects. The third aim of the study is to assess the variability, reliability, and responsiveness of the outcome measures recommended by IMACS using this pilot study of etanercept as the vehicle. The information gained from this study is necessary in order to design larger therapeutic trials of etanercept and other drugs in dermatomyositis.
- Conditions
- Dermatomyositis
- Being tested
- Etanercept, Placebo
- Keywords
- dermatomyositis, etanercept, tumor necrosis factor alpha
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Etanercept 50 mg will be injected subcutaneously once per week for 52 weeks
PlaceboDrug
Also called Saline
Placebo, contained in 50mg syringes, will be injected subcutaneously once per week for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Active comparator | Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected subcutaneously once a week for 52 weeks. Receives: Drug: Etanercept |
| Placebo | Placebo comparator | Subjects will be given syringes containing placebo. Injections will be given subcutaneously, one time per week for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at Least One Adverse Event
Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of "mild", "moderate" or "severe" matches with the descriptions from the CTCAE dictionary.
In general, a "Mild" AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated.
A "Moderate" AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living.
A "Severe" AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling;
Measured: at each visit during the 12 month study
Tolerability
The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment.
Measured: At any point between Baseline (week 0) and the end of the study (Week 52)
Average Change in Oral Temperature From Baseline to Week 52
The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.
Measured: At Baseline (Week 0) and Week 52
Average Change in Respiration Rate From Baseline to Week 52
The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.
Measured: At Baseline (Week0) and Week 52
Average Change in Systolic Blood Pressure From Baseline to Week 52
The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.
Measured: At Baseline (Week0) and Week 52
Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52.
The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.
Measured: At Baseline (Week0) and Week 52
Average Change in Pulse Comparing Baseline to Week 52
The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40.
Measured: At Baseline (Week0) and Week 52
Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52.
The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).
This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40.
Measured: At Baseline (Week0) and Week 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline.
Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant GGT value if during the course of the study, they had at least one clinically significant GGT result that was not present at baseline. Subjects had GGT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant Aldolase value if during the course of the study, they had at least one clinically significant Aldolase result that was not present at baseline. Subjects had Aldolase labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant Glucose value if during the course of the study, they had at least one clinically significant Glucose result that was not present at baseline. Subjects had Glucose labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant White Blood Cell (WBC) value if during the course of the study, they had at least one clinically significant WBC result that was not present at baseline. Subjects had WBC labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant Hemoglobin value if during the course of the study, they had at least one clinically significant Hemoglobin result that was not present at baseline. Subjects had hemoglobin labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant hematocrit value if during the course of the study, they had at least one clinically significant hematocrit result that was not present at baseline. Subjects had hematocrit labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant platelet value if during the course of the study, they had at least one clinically significant platelet result that was not present at baseline. Subjects had platelet labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least 1 clinically significant urine leukocyte result that was not present at baseline. Subjects had urine leukocyte labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine protein result that was not present at baseline. Subjects had urine protein labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine glucose result that was not present at baseline. Subjects had urine glucose labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine ketone result that was not present at baseline. Subjects had urine ketone labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Measured: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant serum 25-hydroxyvitamin D (25-OH VitD) result that was not present at baseline. Subjects had 25-OH VitD labs collected at Screening and at the Week 52 visit.
Measured: Screening visit and Week 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant Antinuclear Antibody Test (ANA) result that was not present at baseline. Subjects had ANA labs collected at Screening, Week 12, 24, 40, and 52.
Measured: At Screening, Week 12, 24, 40, and 52
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.
A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant monoclonal protein value that was not present at baseline. Subjects had monoclonal protein labs collected at Screening, Week 12, 24, 40, and 52.
Measured: Screening visit, Week 12, 24, 40, and 52
Average Cumulative Dosage of Prednisone Over the One Year Study Period
The average cumulative dosage of prednisone over the one year period of the study was calculated. The results are presented by treatment group.
Measured: Baseline until week 52
Secondary outcomes (2)
Average Prednisone Dosage After Week 24
We calculated the average dosage of prednisone from the week 24 visit until the end of the study (week 52).
Measured: from week 24 to 52
Average Daily Dose of Prednisone From Baseline to Week 52
The average daily dose of prednisone from baseline to week 52 was calculated by treatment group.
Measured: Baseline through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2005 (estimated)
- Study startMar 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Investigators
- Anthony A Amato, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112385
- Sponsor's protocol ID
- 1R01NS049639-01A2
- Other IDs
- 1R01NS049639-01A2
- Status last verified
- May 2011
- First submitted
- 2 Jun 2005
- Last updated
- 21 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Muscle Study Group. A randomized, pilot trial of etanercept in dermatomyositis. Ann Neurol. 2011 Sep;70(3):427-36. doi: 10.1002/ana.22477. Epub 2011 Jun 17.
PubMed 21688301
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Etanercept in Dermatomyositis
- ClinicalTrials.gov ID
- NCT00112385
- Acronym / sponsor ID
- 1R01NS049639-01A2
- Conditions
- Dermatomyositis
- Keywords
- dermatomyositis, etanercept, tumor necrosis factor alpha
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Mar 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Jun 2005 (estimated)
- Results
- Posted 21 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to obtain preliminary data regarding the safety and tolerability of etanercept in DM. In addition, we will use the study to assess the variability, reliability, and responsiveness of the core set of outcome measures recommended by IMACS. The study will be performed under the aegis of the Muscle Study Group (MSG), consisting of experienced investigators with an avid interest in myopathies. The ultimate goal of this pilot study will be to obtain necessary, prerequisite information important in designing future therapeutic trials of etanercept and other agents in patients with DM. The specific aims of the study are:
Aim 1: To preliminarily assess the safety and tolerability of etanercept in patients with DM.
Aim 2: To assess the safety and tolerability of prednisone in the dosing schedule we propose to use.
Aim 3: To evaluate outcome measures recommended by IMACS and assess their variability, reliability, and responsiveness in order to facilitate the design of future therapeutic trials in the inflammatory myopathies.
Detailed description
Dermatomyositis (DM) is one of the major subtypes of idiopathic inflammatory myopathy. Prednisone is the initial treatment of choice in most patients with DM. However, because of the high rate of patients with disabling weakness despite treatment with prednisone, the long-term side effects of prednisone, and the many side effects associated with other second-line immunosuppressive agents (e.g., methotrexate, azathioprine), better treatment options are needed. There is evidence that tumor necrosis factor-a (TNF-a) plays a role in the pathogenesis of DM. Thus, etanercept, which blocks TNF-a, is a logical drug to assess in DM. Etanercept has been associated with a number of side effects including an increased risk of infection, inducing other autoimmune diseases, and perhaps cancer. These risks may be further enhanced in DM in which the frequency of other autoimmune disorders (e.g., connective tissue disease) and malignancy are already increased.
The goal of this pilot study will be to assess the safety and tolerability of etanercept in DM.We will perform a double-blind, placebo-controlled pilot study of etanercept in 40 patients with DM randomized in a 3:1 ratio to receive etanercept or placebo. All newly diagnosed and untreated patients will be started on a standard dose of prednisone and tapering schedule. Refractory patients who have been or are currently being treated with prednisone, IVIG, or methotrexate can also participate. Subjects will be followed for 1 year and we will assess various outcome variables recommended by the The International Myositis Assessment Clinical Study Group (IMACS). The primary aim of the study is to preliminarily assess the safety and tolerability of etanercept in patients with DM. We hypothesize that etanercept will be safe and well tolerated in this population. The second aim is to assess the safety and tolerability of prednisone in the dosing schedule we propose to use. We hypothesize that most patients will be able to tolerate the reduction of the prednisone dosage but most will not be able to be completely weaned off the medication. We believe we will find a relationship between prednisone dosage and its related side effects. The third aim of the study is to assess the variability, reliability, and responsiveness of the outcome measures recommended by IMACS using this pilot study of etanercept as the vehicle. The information gained from this study is necessary in order to design larger therapeutic trials of etanercept and other drugs in dermatomyositis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Active comparator | Drug: EtanerceptSubjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected subcutaneously once a week for 52 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be given syringes containing placebo. Injections will be given subcutaneously, one time per week for 52 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Meet the diagnostic criteria for DM (a-c; a,b,d; or a,c,d)
- Newly diagnosed subjects should be able to walk independently 30 feet (cane, walkers, orthoses allowed). However, subjects with refractory dermatomyositis may be non-ambulatory.
- Age > 18 years
- Patients must not use topical skin ointments for treatment of the dermatological manifestations as it will interfere with skin assessment.
- Men and women of childbearing age must be willing to use a method of birth control.
Key exclusion criteria (14 listed)
- Presence of any one of the following medical conditions: active infection, uncontrolled diabetes mellitus, MI, CVA or TIA within 3 months of screening visit, symptomatic cardiomyopathy (congestive heart failure), symptomatic coronary artery disease, uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, systemic lupus erythematosus (SLE), cancer (other than basal cell skin cancer) less than 5 years previously, HIV or other immunosuppressing disease, positive PPD test or any history of mycobacterial disease, chronic hepatitis B or hepatitis C, history of multiple sclerosis, transverse myelitis, optic neuritis, chronic inflammatory demyelinating neuropathy, epilepsy, or other chronic serious medical illnesses
- Presence of any of the following on routine blood screening: WBC<3000, Platelets < 100,000, hematocrit < 30%, BUN > 30 mg %, symptomatic liver disease with serum albumin < 3 G/DL, PT or PTT > upper range of control values
- Forced Vital Capacity < 50% of predicted
- History of non-compliance with other therapies
- Any prior or concurrent cyclophosphamide, or current use of any immunosuppressive agent besides methotrexate (e.g., azathioprine, mycophenolate, or cyclosporine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptEtanercept 50 mg will be injected subcutaneously once per week for 52 weeks | Drug | Etanercept |
| PlaceboAlso: SalinePlacebo, contained in 50mg syringes, will be injected subcutaneously once per week for 52 weeks. | Drug | Placebo |
Primary outcome
Occurrence of at Least One Adverse Event
Time frame: at each visit during the 12 month study
Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of "mild", "moderate" or "severe" matches with the descriptions from the CTCAE dictionary. In general, a "Mild" AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated. A "Moderate" AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living. A "Severe" AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling;
Tolerability
Time frame: At any point between Baseline (week 0) and the end of the study (Week 52)
The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment.
Average Change in Oral Temperature From Baseline to Week 52
Time frame: At Baseline (Week 0) and Week 52
The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.
Average Change in Respiration Rate From Baseline to Week 52
Time frame: At Baseline (Week0) and Week 52
The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.
Average Change in Systolic Blood Pressure From Baseline to Week 52
Time frame: At Baseline (Week0) and Week 52
The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.
Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52.
Time frame: At Baseline (Week0) and Week 52
The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.
Average Change in Pulse Comparing Baseline to Week 52
Time frame: At Baseline (Week0) and Week 52
The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40.
Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52.
Time frame: At Baseline (Week0) and Week 52
The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52
Time frame: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52
Time frame: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline. Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52
Time frame: Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant GGT value if during the course of the study, they had at least one clinically significant GGT result that was not present at baseline. Subjects had GGT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52
Time frame: Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Aldolase value if during the course of the study, they had at least one clinically significant Aldolase result that was not present at baseline. Subjects had Aldolase labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52
Time frame: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Glucose value if during the course of the study, they had at least one clinically significant Glucose result that was not present at baseline. Subjects had Glucose labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52
Time frame: Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52
Time frame: Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant White Blood Cell (WBC) value if during the course of the study, they had at least one clinically significant WBC result that was not present at baseline. Subjects had WBC labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52
Time frame: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant Hemoglobin value if during the course of the study, they had at least one clinically significant Hemoglobin result that was not present at baseline. Subjects had hemoglobin labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52
Time frame: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant hematocrit value if during the course of the study, they had at least one clinically significant hematocrit result that was not present at baseline. Subjects had hematocrit labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52
Time frame: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant platelet value if during the course of the study, they had at least one clinically significant platelet result that was not present at baseline. Subjects had platelet labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52
Time frame: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least 1 clinically significant urine leukocyte result that was not present at baseline. Subjects had urine leukocyte labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52
Time frame: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine protein result that was not present at baseline. Subjects had urine protein labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52
Time frame: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine glucose result that was not present at baseline. Subjects had urine glucose labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52
Time frame: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine ketone result that was not present at baseline. Subjects had urine ketone labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52
Time frame: Screening visit and Week 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant serum 25-hydroxyvitamin D (25-OH VitD) result that was not present at baseline. Subjects had 25-OH VitD labs collected at Screening and at the Week 52 visit.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52
Time frame: At Screening, Week 12, 24, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant Antinuclear Antibody Test (ANA) result that was not present at baseline. Subjects had ANA labs collected at Screening, Week 12, 24, 40, and 52.
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52
Time frame: Screening visit, Week 12, 24, 40, and 52
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant monoclonal protein value that was not present at baseline. Subjects had monoclonal protein labs collected at Screening, Week 12, 24, 40, and 52.
Average Cumulative Dosage of Prednisone Over the One Year Study Period
Time frame: Baseline until week 52
The average cumulative dosage of prednisone over the one year period of the study was calculated. The results are presented by treatment group.
2 secondary outcomes
Average Prednisone Dosage After Week 24
Time frame: from week 24 to 52
Average Daily Dose of Prednisone From Baseline to Week 52
Time frame: Baseline through Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21688301Muscle Study Group. A randomized, pilot trial of etanercept in dermatomyositis. Ann Neurol. 2011 Sep;70(3):427-36. doi: 10.1002/ana.22477. Epub 2011 Jun 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony A Amato, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etanercept in people with Dermatomyositis, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of at Least One Adverse Event (time frame: at each visit during the 12 month study). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00112385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2011.