Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Array Biopharma, now a wholly owned subsidiary of Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosed with rheumatoid arthritis (RA) at least 3 months prior to study start based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
On a stable weekly dose of both methotrexate (MTX) (10 - 25 mg/week inclusively; either oral or parenteral) and folate (≥ 5 mg weekly ) for ≥ 6 weeks prior to study start and is willing to continue on these regimens for the duration of the study.
Meets the ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III.
Completed an appropriate washout period if treated with specified therapies.
Patients may continue on specified stable background therapy for RA (doses should be stable for at least 6 weeks prior to the first dose of study drug, unless the patient stops due to documented disease improvement, with Sponsor approval).
Additional criteria exist.
You may not be if
Diagnosis of any other inflammatory or non-inflammatory arthritis (e.g. spondyloarthritis; fibromyalgia, psoriatic arthritis, crystal-proven gout) that may interfere with disease activity assessments and/or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
Has received any of the following prior treatments:
1. Within 4 weeks of first dose of study drug: anakinra (Kineret®), etanercept (Enbrel®);
2. Within 8 weeks of first dose of study drug: infliximab (Remicade®), adalimumab (Humira®), leflunomide (Arava®);
3. At any time: rituximab (Rituxan®), alemtuzumab (CamPath®), any experimental B cell targeting agents.
Treatment with potent CYP3A inhibitors or inducers, disease-modifying antirheumatic drugs (DMARDs) and/or biologic response modifiers (BRMs) during the study.
Additional criteria exist.
Clareo Health | A Study of ARRY-371797 in Patients With Rheumatoid Arthritis
