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

Overview

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.

Full Title of Study: “Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2015

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.

Interventions

  • Drug: Repository corticotropin injection
    • An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances

Arms, Groups and Cohorts

  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in the Ritchey-Camp Articular Index
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Arthritis Treatment Center, Maryland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nathan Wei, MD, FACP, FACR:, Nathan Wei, MD, FACP, FACR – Arthritis Treatment Center, Maryland
  • Overall Official(s)
    • Nathan Wei, MD, Principal Investigator, Nathan Wei, MD dba Arthritis Treatment Center, Frederick, MD 21702 USA

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