A Phase 2 Study to Evaluate the Efficacy and Safety of 60mg of MM-093 in Patients With Active Rheumatoid Arthritis
A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 60mg of MM-093 Versus Placebo in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate
1 other identifier
interventional
100
1 country
20
Brief Summary
The purpose of this study is to determine whether MM-093 is safe and effective in the treatment of RA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
20 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, 2007
CompletedFirst Submitted
Initial submission to the registry
April 5, 2007
CompletedFirst Posted
Study publicly available on registry
April 9, 2007
CompletedMarch 27, 2008
March 1, 2008
April 5, 2007
March 24, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy of MM-093 using ACR20 response rate
After three months of treatment
Secondary Outcomes (1)
Evaluate the efficacy of MM-093 using DAS-28 and EULAR
After three months of treatment
Study Arms (2)
1
EXPERIMENTALMM-093
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Meet American College of Rheumatology (ACR) criteria for RA.
- Have active RA consisting of \> or equal to 6 tender joints and \> or equal to 6 swollen joints and one of the following:CRP or ESR levels of ULN
- Have an ACR functional class of I-III.
- Have had RA for at least 6 months.
- Had disease onset at \> 16 years of age.
- Aged 18 - 80 years.
- Currently being treated with a stable, well tolerated weekly dose of MTX between 10-25 mg for at least 6 consecutive prior to screening visit.
- Currently being treated with folic/folinic acid in conjunction with their MTX treatment.
- (Note: Patients may begin folic/folinic acid treatment after their screening visit, but must remain on stable dose for two weeks before undergoing the Day 1 assessments.)
- Willing to remain on a constant, weekly dose of MTX and folic/folinic acid through out 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.
- Women of childbearing potential must use a medically acceptable means of birth control in an effective manner and agree to continue its use during the study and for 4 weeks after the last dose of study drug. Women who have had a complete surgical hysterectomy or are postmenopausal (absence of menstrual period for at least one year or \> 52 years old) are exempt from this requirement. Medically acceptable forms of birth control include oral contraceptives, injectable or implantable methods, intrauterine devices, tubal ligation (if performed more than 1 year before screening), or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
- 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.
- Able to store patient kit/cooler containing drug in a refrigerator at home.
You may not qualify if:
- Patient will be excluded if any of the following prior medications are currently being used or have used within the designated time interval before the screening visit:
- Any B - cell or antibody depleting therapy , including plasmaphoresis or Prosorba columns (6 months)
- Leflunomide, Adalimumab (Humira)(3 months)
- Investigational biologics (2 months)
- Infliximab (Remicade) (2 months)
- Cyclosporine, sulphasalazine, auranofin, intramuscular gold, azathioprine, D-penicillamine, tacrolimus (6 weeks)
- Investigational small molecules (e.g. NSAIDS or Cox-2 inhibitors)(4 weeks)
- Use more than 10mg/day of prednisone or equivalent (4 weeks)
- Bolus intramuscular/intravenous (IM/IV) treatment with corticosteroids (\>20 mg prednisone or equivalent)(4 weeks)
- Intra-articular corticosteroid injection (4 weeks)
- Etanercept (Enbrel) (4 weeks)
- Anakinra (Kineret) (2 weeks)
- Use of more than one NSAID (current)
- Dose of NSAID greater than maximum recommended dose in the product information (current)
- Significant concurrent medical diseases including:
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Montgomery Rheumatology Associates
Montgomery, Alabama, 36111, United States
East Valley Rheumatology & Osteoporosis
Gilbert, Arizona, 85234, United States
Radiant Research
Scottsdale, Arizona, 85251, United States
Arthritis Medical Center of the Central Coast
Santa Maria, California, 93454, 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
Trumbull, Connecticut, 06611, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Paddock Park Clinical Research
Ocala, Florida, 34474, United States
Arthritis Research of Florida, Inc.
Palm Harbor, Florida, 34684, United States
Sarasota Arthritis Research Center
Sarasota, Florida, 34239, United States
Illinois Bone & Joint Institute
Morton Grove, Illinois, 60053, United States
Wichita Clinic
Wichita, Kansas, 67208, United States
Arthritis Center of Nebraska
Lincoln, Nebraska, 68516, United States
Arthritis Center of Reno
Reno, Nevada, 89502, United States
Arthritis Center and Carolina Bone and Joint
Charlotte, North Carolina, 28210, United States
East Pennsylvania Rheumatology Association
Bethlehem, Pennsylvania, 18015, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Rheumatology and Internal Medicine
Amarillo, Texas, 79106, 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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 5, 2007
First Posted
April 9, 2007
Study Start
February 1, 2007
Last Updated
March 27, 2008
Record last verified: 2008-03