DermatomyositisADAPTNCT01637064
Dermatomyositis and Polymyositis Registry
An observational study of Dermatomyositis and Polymyositis, run by Phoenix Neurological Associates, LTD at 5 sites in United States.
Trial summary
By creating a registry, physicians will have the opportunity to understand the clinical outcomes of Myositis patients treated with Acthar. Despite the availability of clinical exams, muscle biopsies, and other testing, it is surmised that there may be a more important classification of myositis that physicians are not… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dermatomyositis, Polymyositis
- What is being tested?
- Acthar
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All sites chosen are well-established universities, academic centers or private practices that specialize in neuromuscular diseases. These are physicians who have several myositis patients and who are prescribing or would prescribe Acthar to myositis patients
Who may be able to join
- Age 18-85
- Male or Female
- Clinical or pathologic diagnosis of polymyositis or dermatomyositis
- Capable of providing informed consent and complying with treatment regimen
Who cannot join
- History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex
- Recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin
- Any other co-morbid condition which would make completion of the trial unlikely
- If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
New York Methodist Hospital
Brooklyn, New York, 11215
University of Vermont
Burlington, Vermont, 05401
Neurology INC
Columbia, Missouri, 65201
PNA Center for Neurological Research
Phoenix, Arizona, 85018
Ara Dikranian MD
San Diego, California, 92108
About this study
Official title: Acthar Dermatomyositis and Polymyositis Treatment
By creating a registry, physicians will have the opportunity to understand the clinical outcomes of Myositis patients treated with Acthar. Despite the availability of clinical exams, muscle biopsies, and other testing, it is surmised that there may be a more important classification of myositis that physicians are not diagnosing which could possibly lead to improper treatment due to inaccurate diagnosis. There may be several types of immune and inflammatory myositis (IIM) that do not fit well into the typical sub classifications of myositis.
Read the detailed description
Retrospective and prospective data will be collected from physicians who have prescribed Acthar to myositis patients to determine what specific characteristics each patient has based on biopsy analysis, laboratory results, and clinical exams. Through biopsy analysis, subcategories of IIM will be determined and could illustrate which of these IIMs may be more responsive to Acthar therapy.
- Conditions
- Dermatomyositis, Polymyositis
- Being tested
- Acthar
- Keywords
- Myositis, Acthar treatment
- Medical subject headings
- Dermatomyositis, Polymyositis, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActharDrug
Also called ACTH
Physicians will prescribe Acthar at their own discretion; however the recommended dose is 80 units subcutaneously twice a week.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining if Acthar treatment improves disease progression
To create and maintain a registry linking clinical information, dosing and clinical response in patients with refractory myositis and to determine if Acthar treatment improves disease progression
Measured: 2 years
Secondary outcomes (1)
Subgroups may predict response to Acthar therapy
To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startApr 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenix Neurological Associates, LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd D Levine, MD, Principal investigator, Phoenix Neurological Associates, LTDPetros Efthimiou, MD, Principal investigator, New York Presbyterian Brooklyn Methodist HospitalAra Dikranian, MD, Principal investigator, Ara Dikranian MDJustine Malone, MD, Principal investigator, Neurology INCRup Tandan, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637064
- Sponsor's protocol ID
- ADAPT
- Acronym
- ADAPT
- Status last verified
- Nov 2015
- First submitted
- 6 Jul 2012
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acthar Dermatomyositis and Polymyositis Treatment
- ClinicalTrials.gov ID
- NCT01637064
- Acronym / sponsor ID
- ADAPT / ADAPT
- Conditions
- Dermatomyositis, Polymyositis
- Keywords
- Myositis, Acthar treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Phoenix Neurological Associates, LTDUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By creating a registry, physicians will have the opportunity to understand the clinical outcomes of Myositis patients treated with Acthar. Despite the availability of clinical exams, muscle biopsies, and other testing, it is surmised that there may be a more important classification of myositis that physicians are not diagnosing which could possibly lead to improper treatment due to inaccurate diagnosis. There may be several types of immune and inflammatory myositis (IIM) that do not fit well into the typical sub classifications of myositis.
Detailed description
Retrospective and prospective data will be collected from physicians who have prescribed Acthar to myositis patients to determine what specific characteristics each patient has based on biopsy analysis, laboratory results, and clinical exams. Through biopsy analysis, subcategories of IIM will be determined and could illustrate which of these IIMs may be more responsive to Acthar therapy.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All sites chosen are well-established universities, academic centers or private practices that specialize in neuromuscular diseases. These are physicians who have several myositis patients and who are prescribing or would prescribe Acthar to myositis patients
Key inclusion criteria (4 listed)
- Age 18-85
- Male or Female
- Clinical or pathologic diagnosis of polymyositis or dermatomyositis
- Capable of providing informed consent and complying with treatment regimen
Key exclusion criteria (4 listed)
- History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex
- Recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin
- Any other co-morbid condition which would make completion of the trial unlikely
- If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control
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 |
|---|---|---|
| ActharAlso: ACTHPhysicians will prescribe Acthar at their own discretion; however the recommended dose is 80 units subcutaneously twice a week. | Drug | – |
Primary outcome
Determining if Acthar treatment improves disease progression
Time frame: 2 years
To create and maintain a registry linking clinical information, dosing and clinical response in patients with refractory myositis and to determine if Acthar treatment improves disease progression
1 secondary outcome
Subgroups may predict response to Acthar therapy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
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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.
Todd D Levine, MD principal investigator
Phoenix Neurological Associates, LTD
Petros Efthimiou, MD principal investigator
New York Presbyterian Brooklyn Methodist Hospital
Ara Dikranian, MD principal investigator
Ara Dikranian MD
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatomyositis and Polymyositis, run by Phoenix Neurological Associates, LTD at 5 sites 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Determining if Acthar treatment improves disease progression (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2015.