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

Last updated: July 11, 2016
Sponsor: Arthritis Treatment Center, Maryland
Overall Status: Completed

Phase

4

Condition

Musculoskeletal Diseases

Rheumatoid Arthritis

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT01966718
ATC 005
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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) atleast 1.2 times the upper limit of normal

  • Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for atleast 4 weeks

Exclusion

Exclusion Criteria:

  • Prior treatment with Acthar Gel

  • History of intolerance or allergy to glucocorticoids

  • Unstable diabetes

  • Active infection

Study Design

Total Participants: 8
Study Start date:
October 01, 2013
Estimated Completion Date:
October 31, 2015

Study 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.

Connect with a study center

  • Arthritis Treatment Center

    Frederick, Maryland 21702
    United States

    Site Not Available

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