Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.

Phase 4

Completed

Brief 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.

Detailed Description: Although there are many types of treatment for rheumatoid arthritis (RA) currently available, some patients have disease that is refractory to treatment and cannot achieve remission. The objective of this study is to assess the efficacy and safety of subcutaneous injections of repository corticotropin as an adjunct therapy in patients with active RA who have had an inadequate response to at least two biologic agents as well as a third agent they are currently receiving.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Repository corticotropin injection	Repository corticotropin injection	Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Ritchey-Camp Articular Index	From baseline to week 16	Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.
Change From Baseline in the 20-item Health Assessment Questionnaire Score	From baseline to week 16	Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from "able to do with no difficulties" to "unable to do". A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)	From baseline to week 16	ESR was measured at baseline at week 16. Change was measured by subtracting week 16 score from baseline score. A positive number indicates that the ESR decreased
Change From Baseline in the C-Reactive Protein (CRP) Level	From baseline to week 16	CRP was measured at Baseline and Week 16. Change was calculated by subtracting week 16 value from baseline value, with a positive value indicating a decrease from baseline.