Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center Study

NCT03772145 | Terminated

• 1 other identifier: 18-2435
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.To determine clinical response rates and persistence of therapy with tofacitinib for induction and maintenance therapy
3. 3.Describe the incidence of specific drug-associated adverse events (shingles, serious infections), hospitalizations and surgeries in the standard of care setting.
4. 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

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Inflammatory bowel diseases; Tofacitinib

Outcome Measures

Primary Outcomes (1)

• Change in clinical response from baseline

  Clinical response as assessed by the Simple Clinical Colitis Activity Index (SCCAI)

  At baseline and at approximately 2, 4, 8, 20 and 52 weeks after start of tofacitinib

Secondary Outcomes (2)

• Change in clinical remission from baseline

  At baseline and at approximately 2, 4, 8, 20 and 52

• Persistence of the initial tofacitinib dose

  12 months

Study Arms (1)

Tofacitinib

Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on tofacitinib therapy for moderate to severe UC or who plan to start this therapy within the next 2 weeks. The start of the tofacitinib therapy must have been or be initiated in the setting of standard of care therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on tofacitinib therapy for moderate to severe UC or who plan to start this therapy within the next 2 weeks. The start of the tofacitinib therapy must have been or be initiated in the setting of standard of care therapy

You may qualify if:

• Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on tofacitinib therapy for moderate to severe UC or who plan to start this therapy within the next 2 weeks. The start of the tofacitinib therapy must have been or be initiated in the setting of standard of care therapy
• Anticipation that the patient will be followed by the participating center at least for the next 12 months
• Diagnosis of UC must be established on the basis of standard clinical, radiographic, endoscopic, and histologic criteria as described below.

You may not qualify if:

• \. Patients will be excluded if they meet any of the following criteria:
• Inability to provide informed consent
• Patients presenting for a one-time consultation

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Pfizer: collaborator

Study Sites (1)

Division of Gastroenterology and Hepatology

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

• Long MD, Afzali A, Fischer M, Hudesman D, Abdalla M, McCabe R, Cohen BL, Ungaro RC, Harlan W, Hanson J, Konijeti G, Polyak S, Ritter T, Salzberg B, Seminerio J, English E, Zhang X, Sharma PP, Herfarth HH. Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting. Inflamm Bowel Dis. 2023 Apr 3;29(4):570-578. doi: 10.1093/ibd/izac121.

  PMID: 35700276 RESULT

• Herfarth HH, Afzali A, Fischer M, Hudesman D, Abdalla M, McCabe R, Cohen BL, Ungaro RC, Harlan W, Hanson J, Konijeti GG, Polyak S, Ritter T, Salzberg B, Seminerio J, English E, Zhang X, Long MD. Clinical Long-Term Outcomes of Patient-Reported Outcomes in the Prospective Real-World Tofacitinib Response in Ulcerative Colitis Registry. Clin Transl Gastroenterol. 2024 Mar 1;15(3):e00669. doi: 10.14309/ctg.0000000000000669.

  PMID: 38131617 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Hans Herfarth, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Millie Long

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 11, 2018
• Study Start: November 27, 2018
• Primary Completion: January 29, 2023
• Study Completion: January 29, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

US (1)