Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: infliximab, etanercept, adalimumab; Drug: abatacept, rituximab or tocilizumab

• Registration Number: NCT01000441
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. No controlled trial compared these two strategies face to face. The present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Study Start: 2009-12-23
• Primary Completion: 2013-08-12
• Study Completion: 2013-08-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Active and erosive rheumatoid arthritis with a DAS28 equal or greater than 3.2
• Inadequate response to a 1st anti-TNF
• Stable or no treatment with any DMARDs, or oral corticosteroids (< or = to 10 mg/day of prednisone equivalent)during the preceding month

Exclusion Criteria

• Counter-indication to other anti-TNF, abatacept, rituximab or tocilizumab
• Pregnancy
• Age < 18 years
• Impossibility to give informed consent
• Impossibility to be followed for 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 1 (2d anti-TNF):	infliximab, etanercept, adalimumab	infliximab, etanercept, adalimumab
arm 2 (other biotherapy)	abatacept, rituximab or tocilizumab	abatacept, rituximab or tocilizumab

Primary Outcome Measures

Name	Time	Method
Proportion of EULAR responders	6 months

Trial Locations

Locations (44)

Polyclinique de Picardie; 🇫🇷 Amiens, France

Centre Hospitalier de Belfort-Montbéliard; 🇫🇷 Belfort, France

CHU de Besançon - Hôpital Jean Minjoz; 🇫🇷 Besançon, France

Hôpital Jean Verdier; 🇫🇷 Bondy, France

CHU Bordeaux - Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Ambroise Paré; 🇫🇷 Boulogne - Billancourt, France

CHU de la Cavale Blanche; 🇫🇷 Brest, France

CHU de Caen; 🇫🇷 Caen, France

Centre Hospitalier Jean Rougié; 🇫🇷 Cahors, France

Centre Hospitalier de Cannes; 🇫🇷 Cannes, France

Scroll for more (34 remaining)