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A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
In a population of adult patients who are targeted to initiate adalimumab or previously treated with Humira® to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions.
Primary objective: to define predictive factors for the persistence of treatment
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Adult patients who agreed to initiate treatment with a biosimilar (adalimumab FK) or to replace the reference adalimumab with the adalimumab FK biosimilar |
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| Measure | Description | Time Frame |
|---|---|---|
| Persistence of the biosimilar | Persistence of the biosimilar is defined as the maintenance of FK adalimumab for the twelve-month study period | Month 12 |
| Discontinuation of the biosimilar | Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical status | Clinical Global Impression (CGI)-severity scale graded from 0 to 7 (0 is not evaluated, 1 is the best case and 7 the worst case) | Day 0 |
| Maintenance of therapeutic benefit | Clinical Global Impression (CGI)-improvement scale graded from 0 to 7 (0 is not evaluated, 1 is the best case and 7 the worst case) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with adalimumab for chronic inflammatory rheumatism (CIR) or inflammatory bowel disease (IBD).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carole ROSATI | Contact | 06 26 42 70 58 | 33 | carole.rosati@fresenius-kabi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nouvelle Clinique BONNEFON | Not yet recruiting | Alès | 30100 | France |
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| Month 6 |
| Maintenance of therapeutic benefit | Clinical Global Impression (CGI)-improvement scale graded from 0 to 7 (0 is not evaluated, 1 is the best case and 7 the worst case) | Month 12 |
| Treatment acceptance | Acceptance of the chronic treatment assessed on D0 using the Accept® questionnaire | Day 0 |
| Quality of life assessment | Medical Outcome Study Short Form 12 (MOS SF-12) or "Short Form 12 " (SF-12) scale | Month 12 |
| Emotional state | Screening for symptoms of anxiety and depression involves the use of the HAD questionnaire. | Month 12 |
| Tolerability evaluation | Collection of all adverse events (serious or non serious) | Month 12 |
| Ch Amiens Nord | Recruiting | Amiens | 80054 | France |
|
| Chu Amiens Picardie Site Sud | Recruiting | Amiens | 80054 | France |
|
| Cabinet Médical | Not yet recruiting | Argeles | 66700 | France |
|
| Ch Armentieres | Not yet recruiting | Armentières | 59280 | France |
|
| CH d'ARDECHE MERDIONALE | Not yet recruiting | Aubenas | 07200 | France |
|
| Cabinet de Gastroentérologie | Recruiting | Bayonne | 64100aa | France |
|
| Cabinet Médical | Not yet recruiting | Besançon | 25000 | France |
|
| Chu Besancon Hopital Jean Minjoz | Recruiting | Besançon | 25000 | France |
|
| Clinique du Cèdre | Not yet recruiting | Bois-Guillaume | 76230 | France |
|
| AP HP Ambroise PARE | Not yet recruiting | Boulogne-Billancourt | 92100 | France |
|
| Ch Boulogne Sur Mer | Not yet recruiting | Boulogne-sur-Mer | 62321 | France |
|
| Hôpital Privé SAINT-MARTIN | Recruiting | Caen | 14050 | France |
|
| Centre Consultations Polyclinique St Jean | Recruiting | Cagnes-sur-Mer | 06800 | France |
|
| Ch Cahors | Recruiting | Cahors | 46000 | France |
|
| Infirmerie Protestante de Lyon | Recruiting | Caluire-et-Cuire | 69641 | France |
|
| Clinique du Parc | Recruiting | Castelnau-le-Lez | 34170 | France |
|
| Ch Chateauroux | Recruiting | Châteauroux | 36019 | France |
|
| Cabinet Médical | Not yet recruiting | Chilly-Mazarin | 91380 | France |
|
| CHU CLERMONT FERRAND, site ESTAING | Recruiting | Clermont-Ferrand | 63000 | France |
|
| Chu Gabriell Monpied | Recruiting | Clermont-Ferrand | 63000 | France |
|
| AP HP Hôpital BEAUJON | Recruiting | Clichy | 92110 | France |
|
| Ch Sud Francilien | Recruiting | Corbeil-Essonnes | 91100 | France |
|
| Clinique Claude BERNARD | Not yet recruiting | Ermont | 95120 | France |
|
| Chu Grenoble Sud | Recruiting | Échirolles | 38130 | France |
|
| Ch Annecy Genevois | Recruiting | Épagny | 74370 | France |
|
| Centre Gastro Loire | Not yet recruiting | Gien | 45500 | France |
|
| Ch Haguenau | Recruiting | Haguenau | 67504 | France |
|
| Cabinet Médical | Not yet recruiting | La Madeleine | 59110 | France |
|
| Forum Médica | Recruiting | Lattes | 34970 | France |
|
| Ch Chartres Louis Pasteur | Recruiting | Le Coudray | 28630 | France |
|
| Cabinet Médical Groupe | Not yet recruiting | Le Folgoët | 29260 | France |
|
| AP HP Hôpital BICETRE | Not yet recruiting | Le Kremlin-Bicêtre | 94270 | France |
|
| Cabinet Médical de Rhumatologie | Not yet recruiting | Lézignan-Corbières | 11200 | France |
|
| Chu Dupuytren 2 | Recruiting | Limoges | 87042 | France |
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| Ch Bretagne Sud | Recruiting | Lorient | 56322 | France |
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| Medipole de La Meurthe - Cabinet Médical | Not yet recruiting | Lunéville | 54300 | France |
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| Cabinet Médical TILSITT | Recruiting | Lyon | 69002 | France |
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| Hopital Prive Jean Mermoz Cabinet Medica | Recruiting | Lyon | 69008 | France |
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| Maison Médicale | Recruiting | Marolles-en-Brie | 94440 | France |
|
| Centre Mutualiste LA FEUILLERAIE | Not yet recruiting | Marseille | 13004 | France |
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| AP HM Hôpital NORD | Recruiting | Marseille | 13015 | France |
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| Cabinet de Rhumatologie | Recruiting | Mennecy | 91540 | France |
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| Ch Montauban | Not yet recruiting | Montauban | 82000 | France |
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| Clinique PONT DE CHAUME | Recruiting | Montauban | 82000 | France |
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| MIMOUNE | Recruiting | Montereau-Fault-Yonne | 77130 | France |
|
| Ghi Le Raincy Montfermeil | Recruiting | Montfermeil | 93370 | France |
|
| Chu Hôtel Dieu | Recruiting | Nantes | 44093 | France |
|
| Institut Des Mici-Clinique Ambroise Paré | Recruiting | Neuilly-sur-Seine | 92 200 | France |
|
| Cabinet Médical | Recruiting | Nice | 06000 | France |
|
| Chu Nice Hôpital Pasteur | Recruiting | Nice | 06000 | France |
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| AP HP Hôpital LARRIBOISIERE | Recruiting | Paris | 75010 | France |
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| AP HP Hôpital SAINT ANTOINE | Not yet recruiting | Paris | 75012 | France |
|
| Cabinet Médical | Not yet recruiting | Paris | 75012 | France |
|
| Ap Hp Gh Pitie Salpetriere | Recruiting | Paris | 75013 | France |
|
| Cabinet Médical | Recruiting | Paris | 75013 | France |
|
| Chu Cochin | Recruiting | Paris | 75014 | France |
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| Chu Bichat | Recruiting | Paris | 75018 | France |
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| Ch Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
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| Cabinet Médical | Not yet recruiting | Poissy | 78300 | France |
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| Cabinet Médical | Recruiting | Poitiers | 86000 | France |
|
| Clinique CROIX du SUD | Not yet recruiting | Quint-Fonsegrives | 31130 | France |
|
| Hôpital Robert DEBRE | Recruiting | Reims | 51092 | France |
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| Chu Pontchaillou | Recruiting | Rennes | 35033 | France |
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| Cabinet Médical | Recruiting | Rodez | 12000 | France |
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| Cabinet Médical | Recruiting | Saint-Amand-les-Eaux | 59230 | France |
|
| Hôpital St-Avold Groupe Sos Santé | Recruiting | Saint-Avold | 57500 | France |
|
| Chu Saint Etienne Hôpital Nord | Recruiting | Saint-Etienne | 42055 | France |
|
| Cabinet Médical | Recruiting | Saint-Louis | 68300 | France |
|
| Hôpital d'Instruction des Armées BEGIN | Recruiting | Saint-Mandé | 94160 | France |
|
| Cabinet Médical | Recruiting | Sarreguemines | 57200 | France |
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| Cabinet Médical | Not yet recruiting | Sarreguemines | 57200 | France |
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| Cabinet Médical | Recruiting | Strasbourg | 6700 | France |
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| Cabinet Médical | Not yet recruiting | Strasbourg | 6700 | France |
|
| Ch Strasbourg Hôpital Hautepierre | Recruiting | Strasbourg | 6700 | France |
|
| Nouvel Hôpital Civil | Recruiting | Strasbourg | 67091 | France |
|
| Ch Tarbes Lourdes | Recruiting | Tarbes | 65013 | France |
|
| Hôpital Bel Air | Recruiting | Thionville | 57126 | France |
|
| Cabinet Médical | Recruiting | Toulon | 83000 | France |
|
| HIA Hôpital SAINT-ANNE | Recruiting | Toulon | 83800 | France |
|
| CHU PURPAN Hôpital PIERRE PAUL RIQUET | Recruiting | Toulouse | 31059 | France |
|
| Chu Rangueil | Recruiting | Toulouse | 31059 | France |
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| Clinique PASTEUR | Recruiting | Toulouse | 31076 | France |
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| Clinique MEDIPOLE GARONNE | Recruiting | Toulouse | 31100 | France |
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| Clinique PASTEUR | Recruiting | Toulouse | 31300 | France |
|
| Cabinet Médical | Not yet recruiting | Tourcoing | 59200 | France |
|
| Centre Rééd. Fonct. Trestel - Ch Lannion | Recruiting | Trévou-Tréguignec | 22660 | France |
|
| Hpda Site Clinique Générale | Recruiting | Valence | 26000 | France |
|
| Cabinet de Rhumatologie | Recruiting | Valenciennes | 59300 | France |
|
| Cabinet Médical | Recruiting | Vannes | 56000 | France |
|
| Cabinet Médical | Recruiting | Vannes | 56000 | France |
|
| Ghm Les Portes Du Sud | Recruiting | Vénissieux | 69200 | France |
|
| Ch Villeneuve Pôle de Sante Villeneuvois | Recruiting | Villeneuve-sur-Lot | 47305 | France |
|
| Cabinet Médical | Recruiting | Villeurbanne | 69100 | France |
|
| Cabinet Médical | Recruiting | Pointe-à-Pitre | 97110 | Guadeloupe |
|
| Cabinet Médical | Recruiting | Saint-Pierre | 97410 | Martinique |
|
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| 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 |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
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