NCT04424303 (TOFAST) is a clinical trial of Tofacitinib in Ulcerative Colitis, sponsored by Pfizer.

Who is sponsoring NCT04424303?

NCT04424303 is sponsored by Pfizer.

What drugs are being tested in NCT04424303?

Interventions in NCT04424303: Tofacitinib.

What condition does NCT04424303 study?

NCT04424303 studies Ulcerative Colitis.

Is NCT04424303 still recruiting?

NCT04424303 is currently completed. Last updated 15 January 2026.

Last reviewed 2026-01-15 · How we verify

NCT04424303: TOFAST

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

Completed Last updated 15 January 2026

What this trial tests

trial testing Tofacitinib in Ulcerative Colitis in 152 participants. Completed in 8 December 2025.

Timeline

4 December 2020

Primary endpoint
8 December 2025

8 December 2025

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	152
Start date	4 December 2020
Primary completion	8 December 2025
Estimated completion	8 December 2025
Sites	38 locations across France

Drugs / interventions tested

Tofacitinib (tofacitinib) — full drug profile →

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Anti-IL23/12 agents and JAK inhibitors for inflammatory bowel disease.
Tian Z, Zhao Q, Teng X. · · 2024 · cited 13× · PMID 39086483 · DOI 10.3389/fimmu.2024.1393463
Inflammatory bowel disease therapeutics: a bibliometric analysis of tofacitinib research in ulcerative colitis.
Zhou J, Xi Y, Zhang Y, Zhang R, et al · · 2025 · PMID 40235538 · DOI 10.3389/fphar.2025.1570238

Verify or expand the search:

Other trials of Tofacitinib

Trials testing the same drug.

NCT07530367 — A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Pati · Phase 3 · not yet recruiting
NCT07406204 — Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA) · Phase 4 · not yet recruiting
NCT07343635 — The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined · NA · recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT07297069 — Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial · Phase 2 · not yet recruiting

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04424303 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 15 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04424303.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing