Rheumatoid arthritis (RA)
Conditions
Interventions
12 week treatment with MLN3897 or placebo, taken orally once daily.
Sponsors
Millennium Pharmaceuticals Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-70; 2. Meeting ACR criteria for RA; 3. RA Global Functional Class I,II or III; 4. Taking MTX for a minimum of 6 months before screening, dose stable 3 months; 5. No more than 10 mg/day prednisone/equivalent; 6. Stable use (if on) NSAIDs, at least 2 weeks; 7. Willing/able to comply to the protocol; 8. Female of childbearing potential must not be pregnant, or breastfeeding; 9. Females of childbearing potential and all males must use two accepted forms of contraception for the duration of the study; 10. Have at least 6 tender and 6 swollen joints plus two of the following: morning stiffness >45 minutes, ESR >28 mm/hr, CRP >1.5 mg/dl.
Exclusion criteria
Exclusion criteria: 1. Use of any other DMARDS than MTX concomitantly or within one month prior to enrollment (in case of leflunomide, 3 months prior to enrollment or washout with cholestyramine); 2. Currently being treated with TNF-antagonists or other biologicals (washout period 8 weeks); 3. TB infection; 4. Have received investigational drug one month prior to day1; 5. Have received intra-articular or systemic injection with corticosteroids within one month prior to screening; 6-26 summary: have any other condition or increased risk of a condition or concomitant use of medication incompatible with the study (including infections, liver and kidney diseases, cardiac conditions/arrythmia, etc.) or have a history of cancer, except for distant history of cured ca. in situ of the cervix or BCC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of ACR20 response at day 84 in MLN3897 vs. placebo treated patients; 2. Safety assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. DAS28 response; 2. ACR50/ACR70 response; 3. Change in individual components of ACR criteria; 4. Time to ACR20 response. | — |
Contacts
Public ContactP.P. Tak
Academic Medical Center (AMC), Department of Clinical Immunology and Rheumatology, P.O. Box 22660
Outcome results
None listed