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

Academic Medical Center (AMC)
Department of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 566 2171
Email p.p.tak@amc.nl

Study information

Study designRandomised, placebo controlled, parallel group, double blinded multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA randomised, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate
Study objectivesMLN3897 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) studiedRheumatoid arthritis
Intervention12 week treatment with MLN3897 or placebo, taken orally once daily.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)MLN3897, methotrexate
Primary outcome measure1. Percentage of ACR20 response at day 84 in MLN3897 versus placebo treated patients
2. Safety assessments
Secondary outcome measures1. 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 date01/09/2006
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants186
Total final enrolment191
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2006
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.uva.nl/#http://www.amc.uva.nl/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.