Clinical trial NCT01000441: Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
Official title: Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis with inadequate response to 1 anti-TNF
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of EULAR responders
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Polyclinique de Picardie
city: Belfort
country: France
facility: Centre Hospitalier de Belfort-Montbéliard
city: Besançon
country: France
facility: CHU de Besançon - Hôpital Jean Minjoz
city: Bondy
country: France
facility: Hôpital Jean Verdier
city: Bordeaux
country: France
facility: CHU Bordeaux - Hôpital Pellegrin
city: Boulogne - Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Brest
country: France
facility: CHU de la Cavale Blanche
city: Caen
country: France
facility: CHU de Caen
city: Cahors
country: France
facility: Centre Hospitalier Jean Rougié
city: Cannes
country: France
facility: Centre Hospitalier de Cannes
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital Sud
city: Kremlin Bicetre
country: France
facility: Hôpital Bicêtre
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Départemental Les Oudairies
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre - Hôpital J.Monod
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lievin
country: France
facility: Polyclinique de Riaumont
city: Lille
country: France
facility: CHRU Lille - Hôpital Salengro
city: Limoges
country: France
facility: CHU de Limoges
city: Lomme
country: France
facility: CH Saint Philibert
city: Marseille
country: France
facility: Hôpital de la Conception
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Montpellier
country: France
facility: CHU Montpellier, Hôpital Lapeyronie
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse - Hôpital Emile Muller
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet 1
city: Orleans
country: France
facility: Centre Hospitalier Régional d'Orléans, Hôpital de la Source
city: Paris
country: France
facility: CHU Chenevier - Mondor
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Poitiers
country: France
facility: CHU de Poitiers - Hôpital de la Milétrie
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Reims
country: France
facility: CHU de Reims - Hôpital Maison Blanche
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Sud
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Bois Guillaume
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Purpan
city: Vandoeuvre-les-nancy
country: France
facility: CHU de Nancy - Hôpital Brabois
city: Monaco
country: Monaco
facility: Centre Hospitalier - Princesse Grâce de Monaco
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Jacques-Eric GOTTENBERG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen 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.
citation: Virone 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.
citation: Riviere 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.
citation: 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.