Rheumatoid ArthritisNCT02434757
Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis
A study testing H.P. Acthar Gel in people with Rheumatoid Arthritis, run by Ronald J. Rapoport, MD at 1 site in United States.
Trial summary
This small study is to investigate the efficacy and safety of Acthar as an adjunct therapy in patients with active rheumatoid arthritis (RA) who have had an inadequate response to disease modifying antirheumatic drugs (DMARDs) and at least 3 biologic agents. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- H.P. Acthar Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Nov 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age at the time of participation
- Have a confirmed diagnosis of RA based on the 2010 ACR/EULAR criteria
- Currently on aggressive treatment with an inadequate response or AE to stable dose of DMARDs and biologic agents for 3 months prior to screening, and stable doses of NSAIDs, prednisone or equivalent dose of corticosteroid (dose ≥7.5 mg/d), and analgesics for 28 days prior to screening. Have active RA, defined as ≥6 swollen joints, ≥6 tender joints, plus CRP levels an /or an ESR ≥1.2 the upper limit of normal
- RA for art least 24 months and receiving maximum tolerated doses of at lease 3 biologic agents (at least 1 of which is anti-TNF-a) for 3 months
- Tuberculosis has not occurred within the recent past, as proven by a conventional x-ray, negative tuberculosis shin test (PPD), or quantiferon gold
Who cannot join
- Presence of any condition which could confound interpretation of the data, such as inflammatory arthritis (eg. psoriatic arthritis, gout or pseudogout)
- Presence of systemic fungal infections, recent surgery (within prior 3 months), or active ulcer disease (within the past 5 years)
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic ,hematologic, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease
- Have had in last three months or planning to receive live or live attenuated vaccines
- Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in the study such as uncontrolled diabetes or hypertension
- History of or presence of active or latent tuberculosis (TB) based on QuantiFERON-TB gold test. Patients will be allowed in the study after receiving adequate treatment for TB
Show all 19Show fewer
- Sensitivity to proteins of porcine origin
- History of cancer within the last 5 years, excluding basal cell carcinoma
- Glomerular filtration rate <30 mL/min -
- Uncontrolled diabetes mellitus
- Pregnant of lactating female patients. Each site to administer a pregnancy test to any female of childbearing potential before prescribing Acthar Gel. Only females with negative pregnancy test results are eligible. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the period of the study.
- The following physical and laboratory test findings
- Patients with positive hepatitis B surface antigen
- Patients with positive hepatitis C antibody, who are also positive by recombinant immunoblot assay (RIBA) or by polymerase chain reaction (PCR)
- Hemoglobin level <8.5. g/dL
- White blood cell count <3000/mm (3 x 10/L)
- Serum Creatinine level >2 times upper limit of normal
- Serum alanine aminotransferase (ALT) or asparate amino- transferase (AST) >2 times upper limit of normal
- Any other laboratory test results that, in the opinion of the investigator might placed the patient at unacceptable risk for participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Phase III Clinical Research
Fall River, Massachusetts, 02720
Arlene Turgeon, 508-235-6468, arleneturgeon@yahoo.com
Ronald J. Rapoport, MD
About this study
Official title: Addition of H. P Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis Inadequately Controlled With Biologic Disease-Modifying Antirheumatic Drugs
This small study is to investigate the efficacy and safety of Acthar as an adjunct therapy in patients with active rheumatoid arthritis (RA) who have had an inadequate response to disease modifying antirheumatic drugs (DMARDs) and at least 3 biologic agents. An in adequate response is defined as having ≥ 6 tender joints, ≥ 6 swollen joints, plus C-Reactive Protein (CRP) levels and/or erythrocyte sedimentation rate (ESR) of ≥ 1.2 times the upper limit of normal in spite of aggressive treatment, including ≥ 7.5 mg/d prednisone. This will be a 20 week, prospective, multicenter, open-label study conducted at 3-4 university/medical centers and private practice settings in the US. A total of 20 eligible patients will be enrolled and other standard RA therapeutic agents, such as Methotrexate, DMARDs, non-steroidal anti-inflammatory drugs (NSAIDs), pain medications and others will not be discontinued. The primary endpoint will be the percentage of patients with reduction of ≥1.2 points of the Disease Activity Score in 28 joints (DAS-28) score.
Read the detailed description
>
- Conditions
- Rheumatoid Arthritis
- Being tested
- H.P. Acthar Gel
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.P. Acthar GelDrug
Also called Acthar, Repository Corticotropin Injection, ACTH Gel
Acthar 40 U given SC daily for 7 days. Depending on the response and the Investigator,Acthar 40 U will continue Acthar 40 U 2x per week or increase to Acthar 80 U daily for 7 days followed by 2x per week
| Study group | Role | What they receive |
|---|---|---|
| Acthar 40 U | Experimental | Acthar 40 U (0.5mL) Receives: Drug: H.P. Acthar Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with reduction of >1.2 points in DAS-28 score
Measured: After 12 weeks
20%, 50%, 70% Improvement based on American College of Rheumatology Criteria
Measured: After 12 weeks
Secondary outcomes (3)
Improvement (decrease) in Vectra Disease Activity score
Measured: After 12 weeks
Improvement (decrease) in Health Assessment Questionnaire
Measured: After 12 weeks
Improvement in Functional Assessment of Chronic Illness Therapy Health Related Quality of Life Score
Measured: After 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startFeb 2014
- Primary completionOct 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ronald J. Rapoport, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Ronald J. Rapoport, MD, Phase III Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434757
- Sponsor's protocol ID
- ACT1
- Status last verified
- Sep 2014
- First submitted
- 30 Apr 2015
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of H. P Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis Inadequately Controlled With Biologic Disease-Modifying Antirheumatic Drugs
- ClinicalTrials.gov ID
- NCT02434757
- Acronym / sponsor ID
- ACT1
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ronald J. Rapoport, MDUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 5 May 2015 (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.
This small study is to investigate the efficacy and safety of Acthar as an adjunct therapy in patients with active rheumatoid arthritis (RA) who have had an inadequate response to disease modifying antirheumatic drugs (DMARDs) and at least 3 biologic agents. An in adequate response is defined as having ≥ 6 tender joints, ≥ 6 swollen joints, plus C-Reactive Protein (CRP) levels and/or erythrocyte sedimentation rate (ESR) of ≥ 1.2 times the upper limit of normal in spite of aggressive treatment, including ≥ 7.5 mg/d prednisone. This will be a 20 week, prospective, multicenter, open-label study conducted at 3-4 university/medical centers and private practice settings in the US. A total of 20 eligible patients will be enrolled and other standard RA therapeutic agents, such as Methotrexate, DMARDs, non-steroidal anti-inflammatory drugs (NSAIDs), pain medications and others will not be discontinued. The primary endpoint will be the percentage of patients with reduction of ≥1.2 points of the Disease Activity Score in 28 joints (DAS-28) score.
Detailed description
>
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acthar 40 U | Experimental | Drug: H.P. Acthar GelActhar 40 U (0.5mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years of age at the time of participation
- Have a confirmed diagnosis of RA based on the 2010 ACR/EULAR criteria
- Currently on aggressive treatment with an inadequate response or AE to stable dose of DMARDs and biologic agents for 3 months prior to screening, and stable doses of NSAIDs, prednisone or equivalent dose of corticosteroid (dose ≥7.5 mg/d), and analgesics for 28 days prior to screening. Have active RA, defined as ≥6 swollen joints, ≥6 tender joints, plus CRP levels an /or an ESR ≥1.2 the upper limit of normal
- RA for art least 24 months and receiving maximum tolerated doses of at lease 3 biologic agents (at least 1 of which is anti-TNF-a) for 3 months
- Tuberculosis has not occurred within the recent past, as proven by a conventional x-ray, negative tuberculosis shin test (PPD), or quantiferon gold
Key exclusion criteria (19 listed)
- Presence of any condition which could confound interpretation of the data, such as inflammatory arthritis (eg. psoriatic arthritis, gout or pseudogout)
- Presence of systemic fungal infections, recent surgery (within prior 3 months), or active ulcer disease (within the past 5 years)
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic ,hematologic, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease
- Have had in last three months or planning to receive live or live attenuated vaccines
- Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in the study such as uncontrolled diabetes or hypertension
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 |
|---|---|---|
| H.P. Acthar GelAlso: Acthar, Repository Corticotropin Injection, ACTH GelActhar 40 U given SC daily for 7 days. Depending on the response and the Investigator,Acthar 40 U will continue Acthar 40 U 2x per week or increase to Acthar 80 U daily for 7 days followed by 2x per week | Drug | Acthar 40 U |
Primary outcome
Percentage of patients with reduction of >1.2 points in DAS-28 score
Time frame: After 12 weeks
20%, 50%, 70% Improvement based on American College of Rheumatology Criteria
Time frame: After 12 weeks
3 secondary outcomes
Improvement (decrease) in Vectra Disease Activity score
Time frame: After 12 weeks
Improvement (decrease) in Health Assessment Questionnaire
Time frame: After 12 weeks
Improvement in Functional Assessment of Chronic Illness Therapy Health Related Quality of Life Score
Time frame: After 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H.P. Acthar Gel in people with Rheumatoid Arthritis, run by Ronald J. Rapoport, MD 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 5 inclusion and 19 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 5 May 2015. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with reduction of >1.2 points in DAS-28 score (time frame: After 12 weeks). The study lists 2 primary outcomes in all. 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 5 May 2015.