Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by William Sandborn, MD
Photo of William Sandborn
William Sandborn

Description

Summary

This study aims to provide new mechanistic insights into the molecular determinants of response or nonresponse to tofacitinib therapy and the biological heterogeneity that exists in Ulcerative Colitis. This study will include patients who are initiating tofacitinib therapy according to standard of care. This study consists of: The main study: - Part 1: 8-week induction therapy followed by an 8-week maintenance therapy - Part 2: Patients who continue tofacitinib therapy after part 1 will be followed further for a total of 2 years, or until discontinuation of tofacitinib therapy (whichever is first) The pharmacokinetic and pharmacodynamic substudy: - Patients who consent to the substudy will be randomized (up to 30 subjects maximum) into 1 of 5 arms (different sampling time points), where pharmacokinetics and pharmacodynamics will be analyzed on day 1, week 4, and week 8 of induction of tofacitinib therapy

Official Title

PhaRmacOkinetics and PHarmacodynamic BiomarkErs of TofacItinib Therapy in Patients With Ulcerative Colitis (PROPHETIC)

Keywords

Ulcerative Colitis Colitis Colitis, Ulcerative Ulcer Tofacitinib

Eligibility

You can join if…

Open to people ages 18 years and up

1.18 years of age or older.

2.Male or nonpregnant, nonlactating females.

3.Diagnosis of Ulcerative Colitis for at least 3 months prior to screening.

4.Moderately to severely active Ulcerative Colitis (total Mayo Clinic Score ≥ 6), with objective evidence of inflammation defined by a Mayo endoscopic subscore (MES) ≥ 2 and disease extending > 15 cm from the anal verge.

5.Physician plans to administer tofacitinib for at least 8 weeks as part of Standard of Care (SOC).

6.Documentation of a negative test result for latent tuberculosis within the last 12 months, or according to routine clinical practice.

7.Able to participate fully in all aspects of this clinical trial, including collection of tissue biopsies.

8.Written informed consent must be obtained and documented.

You CAN'T join if...

  1. Diagnosis of Crohn's disease or indeterminate colitis.
  2. An active, serious infection, including localized infections.
  3. Concomitant administration of biological therapies for Ulcerative Colitis or potent immunosuppressants, such as azathioprine and cyclosporine. Subjects with previous exposure to these treatments should undergo an appropriate washout period according to local practice prior to starting tofacitinib, in keeping with routine clinical practice.
  4. Hematology laboratory results that meet the following:
  5. absolute lymphocyte count < 500 cells/mm3
  6. absolute neutrophil count < 1000 cells/mm3
  7. hemoglobin < 9 g/dL
  8. Interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
  9. Serious underlying disease other than Ulcerative Colitis that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
  10. Prior enrollment in the current study and having received tofacitinib.

Locations

  • UCSD accepting new patients
    La Jolla California 92037 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at UCSD

  • William Sandborn, MD
    Chief, Gastroenterology. Authored (or co-authored) 800 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Robarts Clinical Trials Inc.
ID
NCT04576000
Study Type
Observational
Last Updated