|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR856 |
|
Date of registration:
|
29/12/2006 |
|
Primary sponsor: |
|
|
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. - N/A |
|
Date of first enrolment:
|
1/9/2006 |
|
Target sample size:
|
186 |
|
Recruitment status: |
complete |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=856 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
P.P.
Tak |
|
Address:
|
Academic Medical Center (AMC), Department of Clinical Immunology and Rheumatology,
P.O. Box 22660
1100 DD
Amsterdam
The Netherlands |
|
Telephone:
|
+31 (0)20 5662171 |
|
Email:
|
p.p.tak@amc.nl |
|
Affiliation:
|
|
|
|
Name:
|
P.P.
Tak |
|
Address:
|
Academic Medical Center (AMC), Department of Clinical Immunology and Rheumatology,
P.O. Box 22660
1100 DD
Amsterdam
The Netherlands |
|
Telephone:
|
+31 (0)20 5662171 |
|
Email:
|
p.p.tak@amc.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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: 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.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Rheumatoid arthritis
|
|
Intervention(s)
|
|
12 week treatment with MLN3897 or placebo, taken orally once daily.
|
|
Primary Outcome(s)
|
1. Percentage of ACR20 response at day 84 in MLN3897 vs. placebo treated patients;
2. Safety assessments.
|
|
Secondary Outcome(s)
|
1. DAS28 response;
2. ACR50/ACR70 response;
3. Change in individual components of ACR criteria;
4. Time to ACR20 response.
|
|
Secondary ID(s)
|
|
ISRCTN49455679
|
|
N/A
|
|
Source(s) of Monetary Support
|
|
Millennium Pharmaceuticals Inc.
|
|