Last reviewed · How we verify
NCT03772145: TOUR
Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center Study
trial in Ulcerative Colitis in 103 participants. Terminated before completion.
29 January 2023
Quick facts
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 103 |
| Start date | 27 November 2018 |
| Primary completion | 29 January 2023 |
| Estimated completion | 29 January 2024 |
| Sites | 1 location across United States |
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
University of North Carolina, Chapel Hill
Who can join
Adults 18 to 80, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overarching goal of this study, is to create a longitudinally followed, well phenotyped cohort of patients with UC starting treatment with tofacitinib in the setting of standard of care who have linked clinical data and self-reported outcome data that will lead to evaluation of efficacy and safety of tofacitinib in the real-life setting. The specific aims for the study are: 1. Create a prospective cohort of well phenotyped (proctitis vs. rectosigmoiditis vs. extensive) adult UC patients with serial clinical and patient-reported data collected throughout the course of 12 months of tofacitinib therapy. Enrolled patients on therapy will be followed up to 36 months after the start of therapy. 2. To determine clinical response rates and persistence of therapy with tofacitinib for induction and maintenance therapy 3. Describe the incidence of specific drug-associated adverse events (shingles, serious infections), hospitalizations and surgeries in the standard of care setting. 4. Assess the correlation of various outcome measures in ulcerative colitis (Simple Clinical Colitis Activity Index (SCCAI), partial Mayo index, 6-point index) and endoscopic outcomes via the endoscopic Mayo Score
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting.
Long MD, Afzali A, Fischer M, Hudesman D, et al · · 2023 · cited 22× · PMID 35700276 · DOI 10.1093/ibd/izac121 -
Real-world characteristics, treatment experiences and corticosteroid utilisation of patients treated with tofacitinib for moderate to severe ulcerative colitis.
Chiorean MV, Allegretti JR, Sharma PP, Chastek B, et al · · 2022 · cited 4× · PMID 35397501 · DOI 10.1186/s12876-022-02215-y -
Clinical Long-Term Outcomes of Patient-Reported Outcomes in the Prospective Real-World Tofacitinib Response in Ulcerative Colitis Registry.
Herfarth HH, Herfarth HH, Afzali A, Fischer M, et al · · 2024 · cited 1× · PMID 38131617 · DOI 10.14309/ctg.0000000000000669
Verify or expand the search:
- PubMed search for NCT03772145
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 University of North Carolina, Chapel Hill trials
Trials by the same sponsor.
- NCT06841913 — Woodsmoke Exposure, Influenza Infection, and Nasal Immunity · Phase 4 · suspended
- NCT07383428 — The INICIO-Guatemala Study · NA · not yet recruiting
- NCT07528443 — Ultraprocessed Foods in Colombia · NA · not yet recruiting
- NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
- NCT07534254 — Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03772145 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 University of North Carolina, Chapel Hill
- Last refreshed: 31 January 2024
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/NCT03772145.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing