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

August 5, 2021 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Polyclinique de Picardie
      • Belfort, France
        • Centre Hospitalier de Belfort-Montbeliard
      • Besançon, France
        • CHU de Besançon - Hôpital Jean Minjoz
      • Bondy, France
        • Hôpital Jean Verdier
      • Bordeaux, France
        • CHU Bordeaux - Hôpital Pellegrin
      • Boulogne - Billancourt, France
        • Hopital Ambroise Pare
      • Brest, France
        • CHU de la Cavale Blanche
      • Caen, France
        • CHU de Caen
      • Cahors, France
        • Centre Hospitalier Jean Rougie
      • Cannes, France
        • Centre Hospitalier de Cannes
      • Clermont-Ferrand, France
        • Chu Gabriel Montpied
      • Colmar, France
        • Hopitaux Civils de Colmar
      • Grenoble, France
        • CHU de Grenoble - Hôpital Sud
      • Kremlin Bicetre, France
        • Hôpital Bicêtre
      • La Roche Sur Yon, France
        • Centre Hospitalier Départemental Les Oudairies
      • Le Havre, France
        • Groupe Hospitalier du Havre - Hôpital J.Monod
      • Le Mans, France
        • Centre Hospitalier du Mans
      • Lievin, France
        • Polyclinique de Riaumont
      • Lille, France
        • CHRU Lille - Hôpital Salengro
      • Limoges, France
        • CHU de Limoges
      • Lomme, France
        • CH Saint Philibert
      • Marseille, France
        • Hôpital de la Conception
      • Montpellier, France
        • CHU de Montpellier - Hôpital Lapeyronie
      • Montpellier, France
        • CHU Montpellier, Hopital Lapeyronie
      • Mulhouse, France
        • Centre Hospitalier de Mulhouse - Hopital Emile Muller
      • Nantes, France
        • CHU de Nantes - Hôtel Dieu
      • Nice, France
        • CHU de Nice - Hôpital de l'Archet 1
      • Orleans, France
        • Centre Hospitalier Régional d'Orléans, Hôpital de la Source
      • Paris, France
        • Hôpital Saint-Antoine
      • Paris, France
        • Hôpital Lariboisière
      • Paris, France
        • Hopital Bichat
      • Paris, France
        • Hopital de la Pitie Salpetriere
      • Paris, France
        • CHU Chenevier - Mondor
      • Paris, France
        • Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon
      • Poitiers, France
        • CHU de Poitiers - Hôpital de la Milétrie
      • Pontoise, France
        • Centre Hospitalier Rene Dubos
      • Reims, France
        • CHU de Reims - Hôpital Maison Blanche
      • Rennes, France
        • CHU de RENNES - Hôpital Sud
      • Rouen, France
        • CHU de Rouen - Hôpital Bois Guillaume
      • Saint-Etienne, France
        • Chu de Saint-Etienne
      • Strasbourg, France
        • Hopital de Hautepierre
      • Toulouse, France
        • CHU de Toulouse - Hôpital Purpan
      • Vandoeuvre-les-nancy, France
        • CHU de Nancy - Hôpital Brabois
  • Monaco
      • Monaco, Monaco
        • Centre Hospitalier - Princesse Grâce de Monaco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: arm 1 (2d anti-TNF):
infliximab, etanercept, adalimumab
Drug: infliximab, etanercept, adalimumab
Active Comparator: arm 2 (other biotherapy)
abatacept, rituximab or tocilizumab
Drug: abatacept, rituximab or tocilizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of EULAR responders
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Jacques-Eric GOTTENBERG, MD, PhD, Hopitaux Universitaires de Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2009

Primary Completion (Actual)

August 12, 2013

Study Completion (Actual)

August 12, 2013

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 23, 2009

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4507

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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