Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis
Status:
Unknown status
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
This small study is to investigate the efficacy and safety of Acthar as an adjunct therapy in
patients with active rheumatoid arthritis (RA) who have had an inadequate response to disease
modifying antirheumatic drugs (DMARDs) and at least 3 biologic agents. An in adequate
response is defined as having ≥ 6 tender joints, ≥ 6 swollen joints, plus C-Reactive Protein
(CRP) levels and/or erythrocyte sedimentation rate (ESR) of ≥ 1.2 times the upper limit of
normal in spite of aggressive treatment, including ≥ 7.5 mg/d prednisone. This will be a 20
week, prospective, multicenter, open-label study conducted at 3-4 university/medical centers
and private practice settings in the US. A total of 20 eligible patients will be enrolled and
other standard RA therapeutic agents, such as Methotrexate, DMARDs, non-steroidal
anti-inflammatory drugs (NSAIDs), pain medications and others will not be discontinued. The
primary endpoint will be the percentage of patients with reduction of ≥1.2 points of the
Disease Activity Score in 28 joints (DAS-28) score.