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Acthar 40 U for Rheumatoid Arthritis

N/A
Waitlist Available
Research Sponsored by Ronald J. Rapoport, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 12 weeks
Awards & highlights

Study 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. 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.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
20%, 50%, 70% Improvement based on American College of Rheumatology Criteria
Percentage of patients with reduction of >1.2 points in DAS-28 score
Secondary outcome measures
Improvement (decrease) in Health Assessment Questionnaire
Improvement (decrease) in Vectra Disease Activity score
Mental disorders

Trial Design

1Treatment groups
Experimental Treatment
Group I: Acthar 40 UExperimental Treatment1 Intervention
Acthar 40 U (0.5mL)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticotropin
FDA approved

Find a Location

Who is running the clinical trial?

Ronald J. Rapoport, MDLead Sponsor
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,218 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
155 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

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~1 spots leftby Apr 2025