Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX)
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
1 other identifier
interventional
260
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 18, 2005
CompletedFirst Posted
Study publicly available on registry
March 21, 2005
CompletedJuly 11, 2008
July 1, 2008
March 18, 2005
July 10, 2008
Conditions
Outcome Measures
Primary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 4 weeks after the last dose of study drug.
- Women of childbearing potential must use a medically acceptable means of birth control during the study and for 4 weeks after the last dose
- Must be able to store study drug in a refrigerator at home
You may not qualify if:
- 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
- Current use of more than 1 NSAID (non-steroidal anti-inflammatory drug) or dose of NSAID greater than the maximum recommended dose in the product information
- Cancer, or a history of cancer (other than successfully resected cutaneous basal and squamous cell carcinoma) within 5 years before the screening visit.
- Any condition for which participation in this study is judged by the physician to be detrimental to the patient, such as history of significant or unstable cardiac, pulmonary, gastrointestinal, neurological, or psychiatric disease, or a DMARD (Disease-Modifying Anti-Rheumatic Drug)-related severe, potentially life-threatening AE (Adverse Event).
- Significant ongoing infection requiring systemic antibiotic, antifungal, antiviral, or any anti-mycobacterial therapy.
- Autoimmune or connective tissue disorder other than rheumatoid arthritis (e.g. systemic lupus erythematosis, scleroderma or psoriatic arthritis).
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
University of Alabama
Birmingham, Alabama, 35294, United States
Montgomery Rheumatology Associates
Montgomery, Alabama, 36111, United States
Arizona Arthritis Research, PLC
Paradise Valley, Arizona, 85253, United States
ArthroCare, Arthritis Care and Research, Inc.
Phoenix, Arizona, 85012, United States
Radiant Research
Scottsdale, Arizona, 85251, United States
Arthritis Medical Center of the Central Coast
Santa Maria, California, 93454, United States
Boling Clinical Trials
Upland, California, 91786, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
New England Research Associates
Bridgeport, Connecticut, 06606, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
International Medical Research
Ormond Beach, Florida, 32174, United States
Sarasota Arthritis Research Center
Sarasota, Florida, 34239, United States
Center for Arthritis and Rheumatic Diseases
South Miami, Florida, 33143, United States
Coeur d'Alene Arthritis Clinic
Coeur d'Alene, Idaho, 83814, United States
Illinois Bone and Joint Institute
Morton Grove, Illinois, 60016, United States
The Arthritis Center
Springfield, Illinois, 62704, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, 60061, United States
Rheumatology Associates, PC
Indianapolis, Indiana, 46260, United States
Wichita Clinic
Wichita, Kansas, 67208, United States
Rx Trials, Inc.
Columbia, Maryland, 21045, United States
Arthritis Center of Nebraska
Lincoln, Nebraska, 68516, United States
Arthritis Center of Reno
Reno, Nevada, 89502, United States
Arthritis, Osteoporosis & Musculoskeletal Disease Center
Concord, New Hampshire, 03301, United States
Arthritis Health Associates
Syracuse, New York, 13210, United States
Asheville Rheumatology and Osteoporosis Research Associates, Inc
Asheville, North Carolina, 28801, United States
Arthritis Clinic and Carolina Bone and Joint PA
Charlotte, North Carolina, 28210, United States
CARE Center
Raleigh, North Carolina, 27609, United States
North Carolina Arthritis and Allergy Care Center
Raleigh, North Carolina, 27609, United States
Veterans Administration Research Services
Cincinnati, Ohio, 45220, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090, United States
The Arthritis Group
Memphis, Tennessee, 38104, United States
Austin Rheumatology Research
Austin, Texas, 78705, United States
Houston Institute for Clinical Research
Houston, Texas, 77074, United States
Arthritis and Osteoporosis Clinic
Waco, Texas, 76708, United States
University of Utah Division of Rheumatology
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 18, 2005
First Posted
March 21, 2005
Study Start
February 1, 2005
Last Updated
July 11, 2008
Record last verified: 2008-07