| - candidate number | 2382 |
| - NTR Number | NTR856 |
| - ISRCTN | ISRCTN49455679 |
| - Date ISRCTN created | 22-jan-2007 |
| - date ISRCTN requested | 12-jan-2007 |
| - Date Registered NTR | 29-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | A randomized, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate. |
| - Scientific Title | A randomized, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate. |
| - ACRONYM | N/A |
| - hypothesis | MLN3897 is safe and improves signs and symptoms of rheumatoid arthritis. |
| - Healt Condition(s) or Problem(s) studied | Rheumatoid arthritis |
| - 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 | 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-sep-2006 |
| - planned closingdate | 1-sep-2007 |
| - Target number of participants | 186 |
| - Interventions | 12 week treatment with MLN3897 or placebo, taken orally once daily. |
| - Primary outcome | 1. Percentage of ACR20 response at day 84 in MLN3897 vs. placebo treated patients; 2. Safety assessments. |
| - Secondary outcome | 1. DAS28 response; 2. ACR50/ACR70 response; 3. Change in individual components of ACR criteria; 4. Time to ACR20 response. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Prof. Dr. P.P. Tak |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. P.P. Tak |
| - Sponsor/Initiator | Academic Medical Center (AMC) |
| - Funding (Source(s) of Monetary or Material Support) | Millennium Pharmaceuticals Inc. |
| - Publications | N/A |
| - Brief summary | Study Title: A ranomized, Double-Blind, Placebo-controlled, Phase 2a study of the Efficacy, safety and pharmacokinetics of MLN3897 in Patients with active Rheumatoid Arthritis (RA). Primary Objectives: To evaluate: -The ability of MLN3897 to modify signs and symptoms of RA -The safety and tolerability of MLN3897 in combination with methotrexate -the pharmacokinetic/pharmacodynamic profile of MLN3897 in the RA population Number of patients: 186. Study population: The study population will consist of male and female patients aged 18-70 years who have 1) RA with a duration of at least 6 months (based on ACR criteria); 2) an RA Global Functional Class of I,II or III; 3) at least 6 tender and 6 swollen joints at the time of randomization; and 4) at least 2 of 3 criteria (morning stiffness duration >45 minutes, CRP>15, ESR ¡Ý28 mm/hr). Patients must be taking methotrexate for a minimum of 6 months prior to screening. Eligible patients will receive MLN3897 or placebo for 84 days. After the treatment period, there is a 30-day follow-up period. |
| - Main changes (audit trail) | |
| - RECORD | 29-dec-2006 - 9-dec-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl