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

Completed

• Conditions: Rheumatoid arthritis (RA)

• Registration Number: NL-OMON27198
• Lead Sponsor: Millennium Pharmaceuticals Inc.

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 186

Inclusion Criteria

1. Age 18-70;

2. Meeting ACR criteria for RA;

Exclusion Criteria

1. Use of any other DMARDS than MTX concomitantly or within one month prior to enrollment (in case of leflunomide, 3 months prior to enrollment or washout with cholestyramine);

2. Currently being treated with TNF-antagonists or other biologicals (washout period 8 weeks);

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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