A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Dose Levels (2.5, 7.5 and 20 mg) of MM-093 in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Merrimack Pharmaceuticals
- Enrollment
- 260
- Locations
- 38
- Primary Endpoint
- To evaluate the efficacy of 3 different dose levels of MM-093 as measured by the percentage of patients achieving an ACR20 response after 24 weeks compared to placebo
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this clinical study is to see if an experimental drug, called MM-093, is safe and effective in the treatment of rheumatoid arthritis. MM-093 is a genetically engineered version of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have very small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both the mother and the fetus are much higher than normal. It has been observed that women with RA (Rheumatoid Arthritis) have fewer symptoms during pregnancy, particularly during the third trimester. At this time, the levels of AFP in the blood of the mother and fetus are the highest. This observation led researchers to begin examining AFP as a possible treatment for RA.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18-80 years
- •Meet ACR (American College of Rheumatology) criteria for RA
- •Have active RA consisting of 6 or more swollen and 6 or more tender joints
- •Have RA for at least 6 months
- •Had disease onset after 16 years old
- •Currently being treated with a stable, well-tolerated dose of MTX (10 to 25 mg) given once weekly for at least 6 consecutive weeks prior to the screening visit
- •Currently being treated with folic acid
- •Willing to remain on a constant, once-weekly dose of MTX and folic/folinic acid throughout the duration of the study.
- •Understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed.
- •Be able and willing to comply with study visits and procedures per protocol.
Exclusion Criteria
- •Use of any B-cell depleting therapy in the last 6 months
- •Use of Leflunomide or Humira in the last 3 months
- •Use of any investigational drug or biologic agent in the last 2 months
- •Use of Remicade in the last 2 months
- •Use of cyclosporine, sulphasalazine, auranofin, intramuscular gold, azathioprine, D-penicillamine or tacrolimus within the last 6 weeks
- •Use of more than 10 mg/day of prednisone or equivalent in the last 4 weeks
- •Use of intra-articular corticosteroid injection in the last 4 weeks
- •Use of a bolus IM/IV (intramuscular/intravenous) treatment with corticosteroids (\>20 mg prednisone or equivalent) in the last 4 weeks
- •Use of Enbrel in the last 4 weeks
- •Use of Kineret in the last 2 weeks
Outcomes
Primary Outcomes
To evaluate the efficacy of 3 different dose levels of MM-093 as measured by the percentage of patients achieving an ACR20 response after 24 weeks compared to placebo
To evaluate the safety and tolerability of 3 different dose levels of MM-093