Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice.

Phase 3

• Conditions: Arthritis; Rheumatoid Arthritis; 10023213

• Registration Number: NL-OMON29750
• Lead Sponsor: Schering-Plough

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: 36

Inclusion Criteria

Subject has RA according to ACR criteria
Subject aged 18 years or more
Subject received the standard Remicad dosing schedule as per the EU label: 3mg/kg weeks 0, 2 and 6 followed by 1 or 2 intervals of 8 weeks.
DAS 28 worsening of at least 0.6 between the time of initial response and the next 8 weekly infusion and the resulting DAS28 value

Exclusion Criteria

pregnancy
Remicade allergy
patient didn't show an initial response on Remicade (infliximab) during the induction period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study eindpoint is the difference between the mean of the DAS28 in<br /><br>each dose intensification arm as compared to the mean in the control arm. The<br /><br>aim is to show that this differende between the means is at least 0.6.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints:<br /><br><br /><br>- Bone turnover as measured by urine CTX-II<br /><br>- Percentage of patients who regain initial (w6) response<br /><br>- Percentage of patients who drop out for (continued or new) flare<br /><br>- EULAR response, ACR response week 14/22- week 38/46<br /><br>- Other DAS28 cut-off scores for flare and response<br /><br>- Quality of Life measuremment: RA-QOL<br /><br>- Pharmaco-economic evaluation<br /><br>- % of patients who need rescue medication</p><br>