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)

Centre Hospitalier - Princesse Grâce de Monaco; 🇲🇨 Monaco, Monaco

CH Saint Philibert; 🇫🇷 Lomme, France

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

CHU Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Polyclinique de Riaumont; 🇫🇷 Lievin, France

CHU de Limoges; 🇫🇷 Limoges, France

CHU de Reims - Hôpital Maison Blanche; 🇫🇷 Reims, France

CHU de Nancy - Hôpital Brabois; 🇫🇷 Vandoeuvre-les-nancy, France

Polyclinique de Picardie; 🇫🇷 Amiens, France

CHU Bordeaux - Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Ambroise Paré; 🇫🇷 Boulogne - Billancourt, France

Centre Hospitalier de Cannes; 🇫🇷 Cannes, France

CHU de la Cavale Blanche; 🇫🇷 Brest, France

CHU de Caen; 🇫🇷 Caen, France

Centre Hospitalier Jean Rougié; 🇫🇷 Cahors, France

Centre Hospitalier Régional d'Orléans, Hôpital de la Source; 🇫🇷 Orleans, France

Centre Hospitalier René Dubos; 🇫🇷 Pontoise, France

CHU de Grenoble - Hôpital Sud; 🇫🇷 Grenoble, France

Groupe Hospitalier du Havre - Hôpital J.Monod; 🇫🇷 Le Havre, France

Centre Hospitalier du Mans; 🇫🇷 Le Mans, France

CHU de Rennes - Hôpital Sud; 🇫🇷 Rennes, France

CHU Montpellier, Hôpital Lapeyronie; 🇫🇷 Montpellier, France

Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France

Hôpital Bicêtre; 🇫🇷 Kremlin Bicetre, France

CHRU Lille - Hôpital Salengro; 🇫🇷 Lille, France

Hôpital de la Conception; 🇫🇷 Marseille, France

CHU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France

Centre Hospitalier de Mulhouse - Hôpital Emile Muller; 🇫🇷 Mulhouse, France

CHU de Nantes - Hôtel Dieu; 🇫🇷 Nantes, France

CHU de Nice - Hôpital de l'Archet 1; 🇫🇷 Nice, France

CHU Chenevier - Mondor; 🇫🇷 Paris, France

Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon; 🇫🇷 Paris, France

Hôpital Saint-Antoine; 🇫🇷 Paris, France

CHU de Poitiers - Hôpital de la Milétrie; 🇫🇷 Poitiers, France

CHU de Rouen - Hôpital Bois Guillaume; 🇫🇷 Rouen, France

CHU de Toulouse - Hôpital Purpan; 🇫🇷 Toulouse, France

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

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

Hôpital Jean Verdier; 🇫🇷 Bondy, France

Centre Hospitalier Départemental Les Oudairies; 🇫🇷 La Roche Sur Yon, France

Hôpital Bichat; 🇫🇷 Paris, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital de la Pitié Salpétrière; 🇫🇷 Paris, France