A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)

Phase 3

Withdrawn

• Conditions: RA; Reumatoid Atrhritis; 10003816

• Registration Number: NL-OMON46338
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

Patients will be recruited with active RA:
1. Patients who have failed anti-TNF therapy (inadequate responders * ir). Note: this includes patients that have failed anti-TNF therapy because of reactions.
2. Who are eligible for Rituximab/TCZ therapy according the Dutch guidelines*
3. Patients should be receiving a stable dose Methotrexate for at least 4 weeks prior to biopsy visit.
4. 2010 ACR / EULAR Rheumatoid Arthritis classification criteria for a diagnosis of Rheumatoid Arthritis.
5. Over 18 years of age

Exclusion Criteria

1. Women who are pregnant or breast-feeding
2. Women of child-bearing potential, or males whose partners are women of child-bearing potential, unwilling to use effective contraception during the study and for at least 12 months after stopping study treatment.
3. History of or current primary inflammatory joint disease or primary autoimmune disease other than RA.
4. Prior exposure to Rituximab or Tocilizumab for the treatment of RA
5. Treatment with any investigational agent * 4 weeks prior to baseline (or < 5 half lives of the investigational drug, whichever is the longer).
6. Intra articular or parenteral corticosteroids * 4 weeks prior to biopsy visit (Visit 2).
7. Oral prednisolone more than 10mg per day or equivalent * 4 weeks prior to biopsy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patients will be assessed for disease activity using the CDAI (Clinical disease<br /><br>activity index), DAS 28 (CRP/ESR), Health Assessment Questionnaire (HAQ), Short<br /><br>Form 36 and FACIT Fatigue questionnaire as described below.<br /><br><br /><br>Primary Endpoint Efficacy Analysis<br /><br>Treatment response assessed using the Clinical Disease Activity Index (CDAI) at<br /><br>16 weeks. Section 4.11, defines treatment response/failure criteria.<br /><br>Patients deemed treatment failures at 16 weeks, will be switched to the other<br /><br>therapeutic option. Such patients will be considered a new patient starting at<br /><br>week 0 with treatment response assessed again at 16 weeks for primary response.<br /><br>The primary analysis will focus on whether there is a superiority of<br /><br>Tocilizumab over Rituximab in histologically defined *B cell poor* patients.</p><br>