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

January 16, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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-Montbéliard
      • Besançon, France
        • CHU de Besançon - Hôpital Jean Minjoz
      • Bondy, France
        • Hôpital Jean Verdier
      • Bordeaux, France
        • CHU bordeaux - Hopital Pellegrin
      • Boulogne-Billancourt, France
        • Hôpital Ambroise Paré
      • Brest, France
        • CHU de la Cavale Blanche
      • Caen, France
        • CHU de Caen
      • Cahors, France
        • Centre Hospitalier Jean Rougié
      • Cannes, France
        • Centre Hospitalier de Cannes
      • Clermont-Ferrand, France
        • Chu Gabriel Montpied
      • Colmar, France
        • Hôpitaux civils de Colmar
      • Grenoble, France
        • CHU de Grenoble - Hôpital Sud
      • La Roche-sur-Yon, France
        • Centre Hospitalier Departemental Les Oudairies
      • Le Havre, France
        • Groupe Hospitalier du Havre - Hôpital J.Monod
      • Le Kremlin-Bicêtre, France
        • Hôpital Bicêtre
      • Le Mans, France
        • Centre Hospitalier du Mans
      • Lille, France
        • CHRU Lille - Hôpital Salengro
      • Limoges, France
        • CHU de Limoges
      • Liévin, France
        • Polyclinique de Riaumont
      • Lomme, France
        • CH Saint Philibert
      • Marseille, France
        • Hopital de la Conception
      • Montpellier, France
        • CHU de Montpellier - Hôpital Lapeyronie
      • Montpellier, France
        • CHU Montpellier, Hopital Lapeyronie
      • Mulhouse, France
        • Centre Hospitalier de Mulhouse - Hôpital Emile Muller
      • Nantes, France
        • CHU de Nantes - Hôtel Dieu
      • Nice, France
        • CHU de Nice - Hôpital de l'Archet 1
      • Orléans, France
        • Centre Hospitalier Régional d'Orléans, Hôpital de la Source
      • Paris, France
        • Hôpital Saint-Antoine
      • Paris, France
        • Hôpital Lariboisière
      • Paris, France
        • Hôpital Bichat
      • Paris, France
        • Hôpital de la Pitié Salpêtrière
      • 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 René Dubos
      • Reims, France
        • CHU de Reims - Hôpital Maison Blanche
      • Rennes, France
        • CHU de Rennes - Hôpital Sud
      • Rouen, France
        • CHU de Rouen - HOPITAL Bois Guillaume
      • Saint-Etienne, France
        • CHU de Saint-Etienne
      • Strasbourg, France
        • Hôpital de Hautepierre
      • Toulouse, France
        • CHU de Toulouse - Hôpital Purpan
      • Vandœuvre-lès-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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Strasbourg, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 12, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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