Phase 4
Completed N=8
Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.
Source: ClinicalTrials.gov NCT01966718 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Aug 2016
Primary outcomePrimary: Change From Baseline in the Ritchey-Camp Articular Index — 10.25; 9 joints
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
It is hypothesized that repository corticotropin injection in combination with other biologic agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of rheumatoid arthritis for patients with disease that had inadequately responded to biologics previously.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Ritchey-Camp Articular Index |
10.25; 9 | — |
| PRIMARY Change From Baseline in the 20-item Health Assessment Questionnaire Score |
0.03 | — |
| SECONDARY Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) |
1.9 | — |
| SECONDARY Change From Baseline in the C-Reactive Protein (CRP) Level |
0.19 | — |
Eligibility Criteria
Inclusion Criteria
- Rheumatoid arthritis of at least 2 years duration
- On at least third biologic with a different mechanism of action for at least 12 weeks
- Active disease as defined by at least 6 tender and 6 swollen joints
- Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal
- Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at least 4 weeks
Exclusion Criteria
- Prior treatment with Acthar Gel
- History of intolerance or allergy to glucocorticoids
- Unstable diabetes
- Active infection
Data sourced from ClinicalTrials.gov (NCT01966718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.