Evaluating tofacitinib for treating moderate to severe ulcerative colitis in adults
Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study
This study is testing if the medication tofacitinib can help adults with moderate to severe ulcerative colitis feel better over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | tofacitinib |
| Locations | 38 sites (Amiens and 37 other locations) |
| Trial ID | NCT04424303 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of tofacitinib in adult patients with moderate to severe ulcerative colitis over a two-year period in France. It will track clinical benefits one and two years after treatment initiation, analyze predictors of response, and gather real-world data on treatment patterns and patient adherence. The study is designed to provide insights into the efficacy of tofacitinib in routine clinical practice, enhancing understanding of its use in managing ulcerative colitis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of moderate to severe ulcerative colitis who are starting treatment with tofacitinib.
Not a fit: Patients who have previously received tofacitinib or those with contraindications according to the latest guidelines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of tofacitinib, potentially improving treatment strategies for ulcerative colitis patients.
How similar studies have performed: While this study focuses on real-world data, similar studies evaluating tofacitinib have shown promising results in controlled settings, suggesting potential for success in this observational approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of 18 years old or above * Patients with confirmed diagnosis of moderate to severe ulcerative colitis * Patients for whom gastroenterologist decides to initiate treatment with tofacitinib as per the French SmPC * Patients informed about the study procedures and receiving an information letter signed by the investigator Exclusion Criteria: * Patients who have already received tofacitinib treatment before baseline * Patients that fulfill any of the contrindications according to the latest version of the SmPC
Where this trial is running
Amiens and 37 other locations
- Clinique de l Europe — Amiens, France (Active_not_recruiting)
- Hopital Sud — Amiens, France (Active_not_recruiting)
- Hopital Jean Minjoz — Besancon, France (Active_not_recruiting)
- Hopital de La Cote de Nacre — Caen, France (Recruiting)
- Centre Hospitalier de Cahors — Cahors, France (Active_not_recruiting)
- Infirmerie Protestante de Lyon — Caluire, France (Recruiting)
- Hopital Trousseau — Chambray Les Tours, France (Recruiting)
- Hopital D'Estaing — Clermont Ferrand, France (Recruiting)
- Aphp - Hopital Beaujon — Clichy Cedex, France (Active_not_recruiting)
- Ch Intercommunal de Creteil — Creteil Cedex, France (Recruiting)
- Ch Dunkerque — Dunkerque, France (Active_not_recruiting)
- Hopital Albert Michallon — La Tronche, France (Recruiting)
- Ch Bicetre — Le Kremlin Bicetre, France (Active_not_recruiting)
- CH Le Mans — Le Mans, France (Active_not_recruiting)
- Ch Emile Roux — Le Puy En Velay, France (Active_not_recruiting)
- Hopital Claude Huriez — Lille, France (Recruiting)
- Ch Saint Joseph Saint Luc — Lyon, France (Active_not_recruiting)
- Ch Montfermeil — Montfermeil, France (Active_not_recruiting)
- Hopital Saint Eloi — Montpellier Cedex 5, France (Recruiting)
- Clinique Beau Soleil — Montpellier, France (Active_not_recruiting)
- Chu Nantes — Nantes, France (Recruiting)
- Clinique Jules Verne — Nantes, France (Recruiting)
- Hopital de L'Archet — Nice, France (Active_not_recruiting)
- Hopital Caremeau — Nimes, France (Active_not_recruiting)
- Aphp - Hopital Saint Louis — Paris Cedex 10, France (Active_not_recruiting)
- Hopital Europeen Georges Pompidou — Paris, France (Active_not_recruiting)
- Groupe Hospitalier Saint Joseph — Paris, France (Recruiting)
- Chu Bichat Claude Bernard — Paris, France (Active_not_recruiting)
- Chu de Bordeaux - Hopital Haut Leveque — Pessac, France (Recruiting)
- Chu Lyon — Pierre Benite, France (Active_not_recruiting)
- Ch Annecy Genevois — Pringy, France (Active_not_recruiting)
- Chu Rennes — Rennes, France (Recruiting)
- Hopital Nord — St Priest En Jarez Cedex, France (Active_not_recruiting)
- Hopital Rangueil — Toulouse cedex 04, France (Recruiting)
- Clinique Pasteur — Toulouse, France (Recruiting)
- Ch Valence — Valence, France (Active_not_recruiting)
- Ch Valenciennes — Valenciennes, France (Active_not_recruiting)
- Groupe Hospitalier Mutualiste Les Portes du Sud — Venissieux, France (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.