|- candidate number||2382|
|- NTR Number||NTR856|
|- 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.|
|- 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|
|- Type||2 or more arms, randomized|
|- 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.
|- 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), Amsterdam|
(Source(s) of Monetary or Material Support)
|Millennium: The Takeda Oncology Company|
|- 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).
-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.
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|