A randomised, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate
| ISRCTN | ISRCTN49455679 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49455679 |
| Secondary identifying numbers | NL842, NTR856 |
- Submission date
- 22/01/2007
- Registration date
- 22/01/2007
- Last edited
- 15/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof P P Tak
Scientific
Scientific
Academic Medical Center (AMC)
Department of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 2171 |
|---|---|
| p.p.tak@amc.nl |
Study information
| Study design | Randomised, placebo controlled, parallel group, double blinded multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A randomised, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate |
| Study objectives | MLN3897 is safe and improves signs and symptoms of rheumatoid arthritis. |
| Ethics approval(s) | Approval received from the Medical Ethical Committee on the 16th November 2006, amendment one approved on the 29th November 2006 (ref: 06-139). |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | 12 week treatment with MLN3897 or placebo, taken orally once daily. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | MLN3897, methotrexate |
| Primary outcome measure | 1. Percentage of ACR20 response at day 84 in MLN3897 versus placebo treated patients 2. Safety assessments |
| Secondary outcome measures | 1. Disease Activity Scale (DAS28) response 2. ACR50/ACR70 response 3. Change in individual components of ACR criteria 4. Time to ACR20 response |
| Overall study start date | 01/09/2006 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 186 |
| Total final enrolment | 191 |
| Key inclusion criteria | 1. Age 18 to 70 2. Meeting American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis (RA) 3. RA Global Functional Class I,II or III 4. Taking MethoTreXate (MTX) for a minimum of six months before screening, dose stable three months 5. No more than 10 mg/day prednisone/equivalent 6. Stable use of (if on) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), for at least two 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 six tender and six swollen joints plus two of the following: a. morning stiffness more than 45 minutes b. Erythrocyte Sedimentation Rate (ESR) more than 28 mm/hr c. C-Reactive Protein (CRP) more than 1.5 mg/dl |
| Key exclusion criteria | 1. Use of any other Disease Modifying Anti-Rheumatic Drugs (DMARDs) than MTX concomitantly or within one month prior to enrolment (in case of leflunomide, three months prior to enrolment or washout with cholestyramine) 2. Currently being treated with Tumour Necrotising Factor (TNF)-antagonists or other biologicals (washout period eight weeks) 3. Tuberculosis (TB) infection 4. Have received investigational drug one month prior to day one 5. Have received intra-articular or systemic injection with corticosteroids within one month prior to screening 6 to 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 carcinoma in situ of the cervix or Basal Cell Carcinoma (BCC). |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/#http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Industry
Millennium Pharmaceuticals Inc (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2009 | 15/01/2021 | Yes | No |
Editorial Notes
15/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
