SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases

NCT05598684 | Unknown

• 1 other identifier: 2022-A00946-37
• Study Type: observational
• Target: 600
• Locations: 3 countries
• Sites: 96

Brief Summary

A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.

Conditions

Crohn Disease; Ulcerative Colitis; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Clinical status

  Day 0

• Maintenance of therapeutic benefit

  Month 6

• Maintenance of therapeutic benefit

  Month 12

• Treatment acceptance

  Day 0

• Quality of life assessment

  Month 12

Study Arms (1)

Cohort

Adult patients who agreed to initiate treatment with a biosimilar (adalimumab FK) or to replace the reference adalimumab with the adalimumab FK biosimilar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with adalimumab for chronic inflammatory rheumatism (CIR) or inflammatory bowel disease (IBD).

You may qualify if:

• Patient aged 18 years or over
• Patient who have been informed of the objectives and the conditions of the study and who did not object to its participation
• Patient diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases
• Or to initiate adalimumab by prescribing a biosimilar (Adalimumab FK)
• Either to replace Humira® with a biosimilar (AdalimumabFK)

You may not qualify if:

• Patient refusing or unable to comply with the study follow-up procedures (patient not contactable by telephone, unable to complete the self-administered questionnaire, or having poor French language skills, etc.)

Sponsors & Collaborators

• Fresenius Kabi, France: lead

Study Sites (96)

Nouvelle Clinique BONNEFON

Alès, 30100, France

NOT YET RECRUITING

Ch Amiens Nord

Amiens, 80054, France

RECRUITING

Chu Amiens Picardie Site Sud

Amiens, 80054, France

RECRUITING

Cabinet Médical

Argeles, 66700, France

NOT YET RECRUITING

Ch Armentieres

Armentières, 59280, France

NOT YET RECRUITING

CH d'ARDECHE MERDIONALE

Aubenas, 07200, France

NOT YET RECRUITING

Cabinet de Gastroentérologie

Bayonne, 64100aa, France

RECRUITING

Cabinet Médical

Besançon, 25000, France

NOT YET RECRUITING

Chu Besancon Hopital Jean Minjoz

Besançon, 25000, France

RECRUITING

Clinique du Cèdre

Bois-Guillaume, 76230, France

NOT YET RECRUITING

AP HP Ambroise PARE

Boulogne-Billancourt, 92100, France

NOT YET RECRUITING

Ch Boulogne Sur Mer

Boulogne-sur-Mer, 62321, France

NOT YET RECRUITING

Hôpital Privé SAINT-MARTIN

Caen, 14050, France

RECRUITING

Centre Consultations Polyclinique St Jean

Cagnes-sur-Mer, 06800, France

RECRUITING

Ch Cahors

Cahors, 46000, France

RECRUITING

Infirmerie Protestante de Lyon

Caluire-et-Cuire, 69641, France

RECRUITING

Clinique du Parc

Castelnau-le-Lez, 34170, France

RECRUITING

Ch Chateauroux

Châteauroux, 36019, France

RECRUITING

Cabinet Médical

Chilly-Mazarin, 91380, France

NOT YET RECRUITING

CHU CLERMONT FERRAND, site ESTAING

Clermont-Ferrand, 63000, France

RECRUITING

Chu Gabriell Monpied

Clermont-Ferrand, 63000, France

RECRUITING

AP HP Hôpital BEAUJON

Clichy, 92110, France

RECRUITING

Ch Sud Francilien

Corbeil-Essonnes, 91100, France

RECRUITING

Clinique Claude BERNARD

Ermont, 95120, France

NOT YET RECRUITING

Chu Grenoble Sud

Échirolles, 38130, France

RECRUITING

Ch Annecy Genevois

Épagny, 74370, France

RECRUITING

Centre Gastro Loire

Gien, 45500, France

NOT YET RECRUITING

Ch Haguenau

Haguenau, 67504, France

RECRUITING

Cabinet Médical

La Madeleine, 59110, France

NOT YET RECRUITING

Forum Médica

Lattes, 34970, France

RECRUITING

Ch Chartres Louis Pasteur

Le Coudray, 28630, France

RECRUITING

Cabinet Médical Groupe

Le Folgoët, 29260, France

NOT YET RECRUITING

AP HP Hôpital BICETRE

Le Kremlin-Bicêtre, 94270, France

NOT YET RECRUITING

Cabinet Médical de Rhumatologie

Lézignan-Corbières, 11200, France

NOT YET RECRUITING

Chu Dupuytren 2

Limoges, 87042, France

RECRUITING

Ch Bretagne Sud

Lorient, 56322, France

RECRUITING

Medipole de La Meurthe - Cabinet Médical

Lunéville, 54300, France

NOT YET RECRUITING

Cabinet Médical TILSITT

Lyon, 69002, France

RECRUITING

Hopital Prive Jean Mermoz Cabinet Medica

Lyon, 69008, France

RECRUITING

Maison Médicale

Marolles-en-Brie, 94440, France

RECRUITING

Centre Mutualiste LA FEUILLERAIE

Marseille, 13004, France

NOT YET RECRUITING

AP HM Hôpital NORD

Marseille, 13015, France

RECRUITING

Cabinet de Rhumatologie

Mennecy, 91540, France

RECRUITING

Ch Montauban

Montauban, 82000, France

NOT YET RECRUITING

Clinique PONT DE CHAUME

Montauban, 82000, France

RECRUITING

MIMOUNE

Montereau-Fault-Yonne, 77130, France

RECRUITING

Ghi Le Raincy Montfermeil

Montfermeil, 93370, France

RECRUITING

Chu Hôtel Dieu

Nantes, 44093, France

RECRUITING

Institut Des Mici-Clinique Ambroise Paré

Neuilly-sur-Seine, 92 200, France

RECRUITING

Cabinet Médical

Nice, 06000, France

RECRUITING

Chu Nice Hôpital Pasteur

Nice, 06000, France

RECRUITING

AP HP Hôpital LARRIBOISIERE

Paris, 75010, France

RECRUITING

AP HP Hôpital SAINT ANTOINE

Paris, 75012, France

NOT YET RECRUITING

Cabinet Médical

Paris, 75012, France

NOT YET RECRUITING

Ap Hp Gh Pitie Salpetriere

Paris, 75013, France

RECRUITING

Cabinet Médical

Paris, 75013, France

RECRUITING

Chu Cochin

Paris, 75014, France

RECRUITING

Chu Bichat

Paris, 75018, France

RECRUITING

Ch Lyon Sud

Pierre-Bénite, 69495, France

RECRUITING

Cabinet Médical

Poissy, 78300, France

NOT YET RECRUITING

Cabinet Médical

Poitiers, 86000, France

RECRUITING

Clinique CROIX du SUD

Quint-Fonsegrives, 31130, France

NOT YET RECRUITING

Hôpital Robert DEBRE

Reims, 51092, France

RECRUITING

Chu Pontchaillou

Rennes, 35033, France

RECRUITING

Cabinet Médical

Rodez, 12000, France

RECRUITING

Cabinet Médical

Saint-Amand-les-Eaux, 59230, France

RECRUITING

Hôpital St-Avold Groupe Sos Santé

Saint-Avold, 57500, France

RECRUITING

Chu Saint Etienne Hôpital Nord

Saint-Etienne, 42055, France

RECRUITING

Cabinet Médical

Saint-Louis, 68300, France

RECRUITING

Hôpital d'Instruction des Armées BEGIN

Saint-Mandé, 94160, France

RECRUITING

Cabinet Médical

Sarreguemines, 57200, France

RECRUITING

Cabinet Médical

Sarreguemines, 57200, France

NOT YET RECRUITING

Cabinet Médical

Strasbourg, 6700, France

RECRUITING

Cabinet Médical

Strasbourg, 6700, France

NOT YET RECRUITING

Ch Strasbourg Hôpital Hautepierre

Strasbourg, 6700, France

RECRUITING

Nouvel Hôpital Civil

Strasbourg, 67091, France

RECRUITING

Ch Tarbes Lourdes

Tarbes, 65013, France

RECRUITING

Hôpital Bel Air

Thionville, 57126, France

RECRUITING

Cabinet Médical

Toulon, 83000, France

RECRUITING

HIA Hôpital SAINT-ANNE

Toulon, 83800, France

RECRUITING

CHU PURPAN Hôpital PIERRE PAUL RIQUET

Toulouse, 31059, France

RECRUITING

Chu Rangueil

Toulouse, 31059, France

RECRUITING

Clinique PASTEUR

Toulouse, 31076, France

RECRUITING

Clinique MEDIPOLE GARONNE

Toulouse, 31100, France

RECRUITING

Clinique PASTEUR

Toulouse, 31300, France

RECRUITING

Cabinet Médical

Tourcoing, 59200, France

NOT YET RECRUITING

Centre Rééd. Fonct. Trestel - Ch Lannion

Trévou-Tréguignec, 22660, France

RECRUITING

Hpda Site Clinique Générale

Valence, 26000, France

RECRUITING

Cabinet de Rhumatologie

Valenciennes, 59300, France

RECRUITING

Cabinet Médical

Vannes, 56000, France

RECRUITING

Cabinet Médical

Vannes, 56000, France

RECRUITING

Ghm Les Portes Du Sud

Vénissieux, 69200, France

RECRUITING

Ch Villeneuve Pôle de Sante Villeneuvois

Villeneuve-sur-Lot, 47305, France

RECRUITING

Cabinet Médical

Villeurbanne, 69100, France

RECRUITING

Cabinet Médical

Pointe-à-Pitre, 97110, Guadeloupe

RECRUITING

Cabinet Médical

Saint-Pierre, 97410, Martinique

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Central Study Contacts

Carole ROSATI

CONTACT

06 26 42 70 58; carole.rosati@fresenius-kabi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: November 24, 2022
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 12, 2024

Record last verified: 2023-07

Locations

FR (94); GU (1); MA (1)