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

Phase 2

• Conditions: arthritis; chronic joint inflammation; 10003816; 10023213

• Registration Number: NL-OMON30310
• Lead Sponsor: Millenium Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

Patients should:
- Meet the ACR diagnostic criteria for RA
- Have a RA Global Functional Class of I, II, or III
- Be taking MTX for a minimum of 6 months before screening
- If taking oral corticosteroids, no more than 10mg/day and dose unchanged for at least 4 weeks prior to screening
- If taking NSAIDs, stable regimen that has been unchanged for at least 2 weeks prior to screening
- Have at lease 6 swollen joints and 6 tender joints + at least 2 of the following: Morning stiffness with a duration of at least 45 minutes, CRP > 1.5ml.dL or ESR at least 28mm/h

Exclusion Criteria

Patients cannot:
- Be taking any DMARD other than MTX concomitantly or within 1 month prior to study enrollment.
- Currently being treated with TNF-antagonists. A wash out of 8 weeks is permitted.
- suffer from tuberculosis
- have a HIV, Hepatitis B or C infection
- Have evidence of an infectious or acute cardiopulonary process on chest X-ray completed at screening
- suffer from any other serious illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint for efficacy will be the percentage of patients achieving<br /><br>ACR20 at Day 84 in MLN3897 versus placebo-treated patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints for efficacy are as follows:<br /><br>* The percentage of patients achieving ACR50 and ACR70 at Day 84<br /><br>* DAS28-CRP score and the change from baseline to Day 84 in DAS28-CRP score<br /><br>* ACR-N at Day 84<br /><br>* Change from baseline to Day 84 in individual components of ACR response<br /><br>criteria assessment score<br /><br>* Time to ACR20 response</p><br>