No registrations found.
ID
Source
Brief title
Health condition
Rheumatoid arthritis (RA)
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
MLN3897 is safe and improves signs and symptoms of rheumatoid arthritis.
Study design
N/A
Intervention
12 week treatment with MLN3897 or placebo, taken orally once daily.
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL842 |
| NTR-old | NTR856 |
| Other | : N/A |
| ISRCTN | ISRCTN49455679 |