Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
ROC
1 other identifier
interventional
300
2 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 rheumatoid-arthritis
Started Dec 2009
Typical duration for phase_4 rheumatoid-arthritis
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2009
CompletedFirst Posted
Study publicly available on registry
October 23, 2009
CompletedStudy Start
First participant enrolled
December 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2013
CompletedJanuary 20, 2026
January 1, 2026
3.6 years
October 22, 2009
January 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of EULAR responders
6 months
Study Arms (2)
arm 1 (2d anti-TNF):
ACTIVE COMPARATORinfliximab, etanercept, adalimumab
arm 2 (other biotherapy)
ACTIVE COMPARATORabatacept, rituximab or tocilizumab
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
CHU Gabriel Montpied
Clermont-Ferrand, France
Hôpitaux Civils de Colmar
Colmar, France
CHU de Grenoble - Hôpital Sud
Grenoble, France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, France
Groupe Hospitalier du Havre - Hôpital J.Monod
Le Havre, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Centre Hospitalier du Mans
Le Mans, France
Polyclinique de Riaumont
Liévin, France
CHRU Lille - Hôpital Salengro
Lille, France
CHU de Limoges
Limoges, France
CH Saint Philibert
Lomme, France
Hôpital de la Conception
Marseille, France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France
CHU 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
Centre Hospitalier Régional d'Orléans, Hôpital de la Source
Orléans, France
CHU Chenevier - Mondor
Paris, France
Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon
Paris, France
Hôpital Bichat
Paris, France
Hôpital de la Pitié Salpétrière
Paris, France
Hôpital Lariboisière
Paris, France
Hôpital Saint-Antoine
Paris, France
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, France
Centre Hospitalier René Dubos
Pontoise, France
CHU de Reims - Hôpital Maison Blanche
Reims, France
CHU de Rennes - Hôpital Sud
Rennes, France
CHU de Rouen - Hôpital Bois Guillaume
Rouen, France
CHU de Saint-Etienne
Saint-Etienne, France
Hôpital de Hautepierre
Strasbourg, France
CHU de Toulouse - Hôpital Purpan
Toulouse, France
CHU de Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy, France
Centre Hospitalier - Princesse Grâce de Monaco
Monaco, Monaco
Related Publications (4)
Gottenberg JE, Brocq O, Perdriger A, Lassoued S, Berthelot JM, Wendling D, Euller-Ziegler L, Soubrier M, Richez C, Fautrel B, Constantin AL, Mariette X, Morel J, Gilson M, Cormier G, Salmon JH, Rist S, Liote F, Marotte H, Bonnet C, Marcelli C, Sellam J, Meyer O, Solau-Gervais E, Guis S, Ziza JM, Zarnitsky C, Chary-Valckenaere I, Vittecoq O, Saraux A, Pers YM, Gayraud M, Bolla G, Claudepierre P, Ardizzone M, Dernis E, Breban MA, Fain O, Balblanc JC, Aberkane O, Vazel M, Back C, Candon S, Chatenoud L, Perrodeau E, Sibilia J, Ravaud P. Non-TNF-Targeted Biologic vs a Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients With Insufficient Response to a First Anti-TNF Drug: A Randomized Clinical Trial. JAMA. 2016 Sep 20;316(11):1172-1180. doi: 10.1001/jama.2016.13512.
PMID: 27654603RESULTNguyen MVC, Courtier A, Adrait A, Defendi F, Coute Y, Baillet A, Guigue L, Gottenberg JE, Dumestre-Perard C, Brun V, Gaudin P. Fetuin-A and thyroxin binding globulin predict rituximab response in rheumatoid arthritis patients with insufficient response to anti-TNFalpha. Clin Rheumatol. 2020 Sep;39(9):2553-2562. doi: 10.1007/s10067-020-05030-6. Epub 2020 Mar 24.
PMID: 32212002DERIVEDVirone A, Bastard JP, Fellahi S, Capeau J, Rouanet S, Sibilia J, Ravaud P, Berenbaum F, Gottenberg JE, Sellam J. Comparative effect of tumour necrosis factor inhibitors versus other biological agents on cardiovascular risk-associated biomarkers in patients with rheumatoid arthritis. RMD Open. 2019 Jul 21;5(2):e000897. doi: 10.1136/rmdopen-2019-000897. eCollection 2019.
PMID: 31413865DERIVEDRiviere E, Sellam J, Pascaud J, Ravaud P, Gottenberg JE, Mariette X. Serum IL-33 level is associated with auto-antibodies but not with clinical response to biologic agents in rheumatoid arthritis. Arthritis Res Ther. 2018 Jun 8;20(1):122. doi: 10.1186/s13075-018-1628-6.
PMID: 29884223DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques-Eric GOTTENBERG, MD, PhD
Hôpitaux Universitaires de Strasbourg
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2009
First Posted
October 23, 2009
Study Start
December 23, 2009
Primary Completion
August 12, 2013
Study Completion
August 12, 2013
Last Updated
January 20, 2026
Record last verified: 2026-01