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A randomized, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate.


- candidate number2382
- NTR NumberNTR856
- ISRCTNISRCTN49455679
- Date ISRCTN created22-jan-2007
- date ISRCTN requested12-jan-2007
- Date Registered NTR29-dec-2006
- Secondary IDsN/A 
- Public TitleA randomized, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate.
- Scientific TitleA randomized, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate.
- ACRONYMN/A
- hypothesisMLN3897 is safe and improves signs and symptoms of rheumatoid arthritis.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2006
- planned closingdate1-sep-2007
- Target number of participants186
- Interventions12 week treatment with MLN3897 or placebo, taken orally once daily.
- Primary outcome1. Percentage of ACR20 response at day 84 in MLN3897 vs. placebo treated patients;
2. Safety assessments.
- Secondary outcome1. DAS28 response;
2. ACR50/ACR70 response;
3. Change in individual components of ACR criteria;
4. Time to ACR20 response.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.P. Tak
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Millennium Pharmaceuticals Inc.
- PublicationsN/A
- Brief summaryStudy 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 28 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)
- RECORD29-dec-2006 - 9-dec-2009


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