Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
NCT ID: NCT01000441
Last Updated: 2021-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2009-12-23
2013-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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arm 1 (2d anti-TNF):
infliximab, etanercept, adalimumab
infliximab, etanercept, adalimumab
arm 2 (other biotherapy)
abatacept, rituximab or tocilizumab
abatacept, rituximab or tocilizumab
Interventions
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infliximab, etanercept, adalimumab
abatacept, rituximab or tocilizumab
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
* Age \< 18 years
* Impossibility to give informed consent
* Impossibility to be followed for 12 months
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
Principal Investigators
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Jacques-Eric GOTTENBERG, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Locations
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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
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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4507
Identifier Type: -
Identifier Source: org_study_id
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