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 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 trial start date
01/09/2006
Overall trial end date
01/09/2007
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list