Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX)
NCT ID: NCT00105976
Last Updated: 2008-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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MM-093
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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).
* Grade 2 or above leukopenia (i.e. white blood cells \< 3000/mm3 \[SI units: \< 3.0 x 10\^9/L\]).
* Thrombocytopenia or thrombocytosis (platelets \< 125,000/mm3 or ≥ 1,000,000/mm3 \[SI units: \< 125 x 10\^9/L or ≥ 1,000 x 10\^9/L\]), respectively.
* Grade 2 or above liver function abnormality (i.e. total bilirubin \> 1.5 x the upper limit of normal; or aspartate aminotransferase \[AST/SGOT\] or alanine aminotransferase \[ALT/SGPT\] \> 2.5 x upper limit of normal).
* Renal disease (including serum creatinine level \> 1.5 x the upper limit of normal).
* Any history of immunodeficiency syndromes or infection with human immunodeficiency virus (HIV), or a history of hepatitis C or chronic hepatitis B.
* Pregnant or breastfeeding women or women planning to become pregnant during the study or within 4 weeks after the last dose of study drug.
* Any major surgery, including joint surgery, within 3 months before screening visit.
* Scheduled elective surgery during study participation.
* Participated in any previous clinical trial using MM-093 or have any prior exposure to MM-093.
* History of severe hypersensitivity to goat, sheep or cow milk or products derived from goat, sheep or cow milk (patients who are lactose intolerant are not excluded).
* Any other condition that the investigator feels would jeopardize the integrity of the study (e.g. a CTCAE \[Common Terminology Criteria for Adverse Events\] grade 2 or above clinical finding or laboratory result).
18 Years
80 Years
ALL
No
Sponsors
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Merrimack Pharmaceuticals
INDUSTRY
Locations
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University of Alabama
Birmingham, Alabama, United States
Montgomery Rheumatology Associates
Montgomery, Alabama, United States
Arizona Arthritis Research, PLC
Paradise Valley, Arizona, United States
ArthroCare, Arthritis Care and Research, Inc.
Phoenix, Arizona, United States
Radiant Research
Scottsdale, Arizona, United States
Arthritis Medical Center of the Central Coast
Santa Maria, California, United States
Boling Clinical Trials
Upland, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Denver Arthritis Clinic
Denver, Colorado, United States
New England Research Associates
Bridgeport, Connecticut, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
International Medical Research
Ormond Beach, Florida, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Center for Arthritis and Rheumatic Diseases
South Miami, Florida, United States
Coeur d'Alene Arthritis Clinic
Coeur d'Alene, Idaho, United States
Illinois Bone and Joint Institute
Morton Grove, Illinois, United States
The Arthritis Center
Springfield, Illinois, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, United States
Rheumatology Associates, PC
Indianapolis, Indiana, United States
Wichita Clinic
Wichita, Kansas, United States
Rx Trials, Inc.
Columbia, Maryland, United States
Arthritis Center of Nebraska
Lincoln, Nebraska, United States
Arthritis Center of Reno
Reno, Nevada, United States
Arthritis, Osteoporosis & Musculoskeletal Disease Center
Concord, New Hampshire, United States
Arthritis Health Associates
Syracuse, New York, United States
Asheville Rheumatology and Osteoporosis Research Associates, Inc
Asheville, North Carolina, United States
Arthritis Clinic and Carolina Bone and Joint PA
Charlotte, North Carolina, United States
CARE Center
Raleigh, North Carolina, United States
North Carolina Arthritis and Allergy Care Center
Raleigh, North Carolina, United States
Veterans Administration Research Services
Cincinnati, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, United States
The Arthritis Group
Memphis, Tennessee, United States
Austin Rheumatology Research
Austin, Texas, United States
Houston Institute for Clinical Research
Houston, Texas, United States
Arthritis and Osteoporosis Clinic
Waco, Texas, United States
University of Utah Division of Rheumatology
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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MM-093-01-200
Identifier Type: -
Identifier Source: org_study_id