Condition category
Musculoskeletal Diseases
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
26/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof P P Tak

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 2171
p.p.tak@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

MLN3897 is safe and improves signs and symptoms of rheumatoid arthritis.

Ethics approval

Approval received from the Medical Ethical Committee on the 16th November 2006, amendment one approved on the 29th November 2006 (ref: 06-139).

Study design

Randomised, placebo controlled, parallel group, double blinded multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Rheumatoid arthritis

Intervention

12 week treatment with MLN3897 or placebo, taken orally once daily.

Intervention type

Drug

Phase

Phase II

Drug names

MLN3897, methotrexate

Primary outcome measures

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 trial start date

01/09/2006

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

186

Participant 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).

Recruitment start date

01/09/2006

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/#http://www.amc.uva.nl/

Funders

Funder type

Industry

Funder name

Millennium Pharmaceuticals Inc (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes