Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | September 2015 |
| Contact: | Michelle Grimm |
| Email: | mgrimm@arthritistreatmentcenter.com |
| Phone: | 301-624-1164 |
Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action
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.
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.
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.
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.
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
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