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.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Acthar 40 U given SC daily for 7 days. Depending on the response and the Investigator,Acthar 40 U will continue Acthar 40 U 2x per week or increase to Acthar 80 U daily for 7 days followed by 2x per week
Phase III Clinical Research
Fall River, Massachusetts, United States
RECRUITINGPercentage of patients with reduction of >1.2 points in DAS-28 score
Time frame: After 12 weeks
20%, 50%, 70% Improvement based on American College of Rheumatology Criteria
Time frame: After 12 weeks
Improvement (decrease) in Vectra Disease Activity score
Time frame: After 12 weeks
Improvement (decrease) in Health Assessment Questionnaire
Time frame: After 12 weeks
Improvement in Functional Assessment of Chronic Illness Therapy Health Related Quality of Life Score
Time frame: After 12 weeks
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