- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02434757
Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis
April 30, 2015 updated by: Ronald J. Rapoport, MD
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.
Study Overview
Detailed Description
>
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Fall River, Massachusetts, United States, 02720
- Recruiting
- Phase Iii Clinical Research
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Contact:
- Arlene Turgeon
- Phone Number: 508-235-6468
- Email: arleneturgeon@yahoo.com
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Principal Investigator:
- Ronald J. Rapoport, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acthar 40 U
Acthar 40 U (0.5mL)
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients with reduction of >1.2 points in DAS-28 score
Time Frame: After 12 weeks
|
After 12 weeks
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20%, 50%, 70% Improvement based on American College of Rheumatology Criteria
Time Frame: After 12 weeks
|
After 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement (decrease) in Vectra Disease Activity score
Time Frame: After 12 weeks
|
After 12 weeks
|
Improvement (decrease) in Health Assessment Questionnaire
Time Frame: After 12 weeks
|
After 12 weeks
|
Improvement in Functional Assessment of Chronic Illness Therapy Health Related Quality of Life Score
Time Frame: After 12 weeks
|
After 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
November 1, 2015
Study Registration Dates
First Submitted
April 30, 2015
First Submitted That Met QC Criteria
April 30, 2015
First Posted (Estimate)
May 5, 2015
Study Record Updates
Last Update Posted (Estimate)
May 5, 2015
Last Update Submitted That Met QC Criteria
April 30, 2015
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACT1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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