A randomised, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate

Phase 2

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases; Arthropathies

• Registration Number: ISRCTN49455679
• Lead Sponsor: Academic Medical Center (AMC) (The Netherlands)

Brief Summary

2009 results in https://pubmed.ncbi.nlm.nih.gov/19950299/ (added 15/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-22
• Study Completion: 2007-09-01
• Last Update Posted: 25 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 191

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Percentage of ACR20 response at day 84 in MLN3897 versus placebo treated patients<br> 2. Safety assessments<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Disease Activity Scale (DAS28) response<br> 2. ACR50/ACR70 response<br> 3. Change in individual components of ACR criteria<br> 4. Time to ACR20 response<br>