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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 (2d anti-TNF): | Active Comparator | infliximab, etanercept, adalimumab |
|
| arm 2 (other biotherapy) | Active Comparator | abatacept, rituximab or tocilizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infliximab, etanercept, adalimumab | Drug |
| ||
| abatacept, rituximab or tocilizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of EULAR responders | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques-Eric GOTTENBERG, MD, PhD | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique de Picardie | Amiens | France | ||||
| Centre Hospitalier de Belfort-Montbéliard |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27654603 | Result | 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. | |
| 32212002 |
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| Drug |
|
| 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 |
| Derived |
| 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. |
| 31413865 | Derived | 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. |
| 29884223 | Derived | 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. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D000068800 | Etanercept |
| D000068879 | Adalimumab |
| D000069594 | Abatacept |
| D000069283 | Rituximab |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D018796 | Immunoconjugates |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
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