Ulcerative ColitisTOURNCT03772145
Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center Study
An observational study of Ulcerative Colitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2018to 29 Jan 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 1. Patients will be excluded if they meet any of the following criteria:
- Inability to provide informed consent
- Patients presenting for a one-time consultation
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Gastroenterology and Hepatology
Chapel Hill, North Carolina, 27599
About this study
Official title: TOUR: Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center Study
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:
- 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.
- To determine clinical response rates and persistence of therapy with tofacitinib for induction and maintenance therapy
- Describe the incidence of specific drug-associated adverse events (shingles, serious infections), hospitalizations and surgeries in the standard of care setting.
- 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
Read the detailed description
The proposed prospective tofacitinib registry is a prospective patient cohort with the goal of evaluating the efficacy and safety of this drug in "real life". All patients starting tofacitinib for ulcerative colitis in the setting of standard of care therapy will be eligible within of 4 weeks of start of therapy. Preferentially, patients will be enrolled at the visit where therapy is initiated. At baseline patient characteristics including extent of disease, previous therapies (including number of previously failed biologics) and pro-inflammatory laboratory markers (CRP, if available calprotectin) will be captured in a prospective web-based database. Additionally, each consented study participant will be enrolled in a web-based prospective patient powered registry (PPR) to evaluate patient report outcomes (PRO's) (such as validated measures for depression, social satisfaction, pain, fatigue) and safety events (e.g. hospitalizations; herpes zoster, complications requiring discontinuation of tofacitinib).
The following outcomes will be assessed: Response and remission as assessed by the Simple Clinical Colitis Activity Index (SCCAI) (primary endpoint), in addition secondary outcomes will include: the partial Mayo score, the 6-point subscore of the Mayo score, and the Manitoba index, need for steroids, need for surgery or hospitalization, need for dosing intensification or reduction of dosing as well as persistence of tofacitinib therapy. Endoscopy information will be collected if done as part of routine care, but the study will not have an endoscopic requirement. Sites will be encouraged to report a Mayo endoscopic score if done as part of routine care as a secondary endpoint. The outcomes will be determined in the setting of the standard of care visits, which normally are scheduled at the end of induction (approx. 6-12 weeks after the start of tofacitinib) and during maintenance therapy after 4-6 and 9-12 months and then every 3-4 months up to 36 months. PRO's and safety will be assessed with the PPR instrument at baseline, daily in the first 2 weeks to better understand rapidity of onset, and after 6,10,14,22,30,38,46 and 54 weeks and then every 3-4 months up to 36 months. The analyses of these data will facilitate UC patient care and improve the overall quality of IBD therapy in the US and worldwide. This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Institutional research policies and procedures.
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, Inflammatory bowel diseases, Tofacitinib
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical response from baseline
Clinical response as assessed by the Simple Clinical Colitis Activity Index (SCCAI)
Measured: 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
Clinical remission as assessed by the Simple Clinical Colitis Activity Index (SCCAI)
Measured: At baseline and at approximately 2, 4, 8, 20 and 52
Persistence of the initial tofacitinib dose
Persistence of initial tofacitinib dose
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start27 Nov 2018
- Primary completion29 Jan 2023
- Study completion29 Jan 2024
Why it stopped: Futility; recruitment to slow to justify longer study duration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Hans Herfarth, MD, Principal investigator, University of North CarolinaMillie Long, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772145
- Sponsor's protocol ID
- 18-2435
- Acronym
- TOUR
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2018
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is currently no plan to share the anonymized data with other investigators. But this may change in the future
Publications
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.
PubMed 35700276Herfarth 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.
PubMed 38131617
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOUR: Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center Study
- ClinicalTrials.gov ID
- NCT03772145
- Acronym / sponsor ID
- TOUR / 18-2435
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, Inflammatory bowel diseases, Tofacitinib
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Futility; recruitment to slow to justify longer study duration
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 29 Jan 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To determine clinical response rates and persistence of therapy with tofacitinib for induction and maintenance therapy
- Describe the incidence of specific drug-associated adverse events (shingles, serious infections), hospitalizations and surgeries in the standard of care setting.
- 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
Detailed description
The proposed prospective tofacitinib registry is a prospective patient cohort with the goal of evaluating the efficacy and safety of this drug in "real life". All patients starting tofacitinib for ulcerative colitis in the setting of standard of care therapy will be eligible within of 4 weeks of start of therapy. Preferentially, patients will be enrolled at the visit where therapy is initiated. At baseline patient characteristics including extent of disease, previous therapies (including number of previously failed biologics) and pro-inflammatory laboratory markers (CRP, if available calprotectin) will be captured in a prospective web-based database. Additionally, each consented study participant will be enrolled in a web-based prospective patient powered registry (PPR) to evaluate patient report outcomes (PRO's) (such as validated measures for depression, social satisfaction, pain, fatigue) and safety events (e.g. hospitalizations; herpes zoster, complications requiring discontinuation of tofacitinib).
The following outcomes will be assessed: Response and remission as assessed by the Simple Clinical Colitis Activity Index (SCCAI) (primary endpoint), in addition secondary outcomes will include: the partial Mayo score, the 6-point subscore of the Mayo score, and the Manitoba index, need for steroids, need for surgery or hospitalization, need for dosing intensification or reduction of dosing as well as persistence of tofacitinib therapy. Endoscopy information will be collected if done as part of routine care, but the study will not have an endoscopic requirement. Sites will be encouraged to report a Mayo endoscopic score if done as part of routine care as a secondary endpoint. The outcomes will be determined in the setting of the standard of care visits, which normally are scheduled at the end of induction (approx. 6-12 weeks after the start of tofacitinib) and during maintenance therapy after 4-6 and 9-12 months and then every 3-4 months up to 36 months. PRO's and safety will be assessed with the PPR instrument at baseline, daily in the first 2 weeks to better understand rapidity of onset, and after 6,10,14,22,30,38,46 and 54 weeks and then every 3-4 months up to 36 months. The analyses of these data will facilitate UC patient care and improve the overall quality of IBD therapy in the US and worldwide. This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Institutional research policies and procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 1. Patients will be excluded if they meet any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in clinical response from baseline
Time frame: At baseline and at approximately 2, 4, 8, 20 and 52 weeks after start of tofacitinib
Clinical response as assessed by the Simple Clinical Colitis Activity Index (SCCAI)
2 secondary outcomes
Change in clinical remission from baseline
Time frame: At baseline and at approximately 2, 4, 8, 20 and 52
Persistence of the initial tofacitinib dose
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Futility; recruitment to slow to justify longer study duration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Results publication: PubMed 35700276Long 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.
- Results publication: PubMed 38131617Herfarth 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.
- Individual participant dataSharing planned: Undecided. There is currently no plan to share the anonymized data with other investigators. But this may change in the future
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Herfarth, MD principal investigator
University of North Carolina
Millie Long principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Futility; recruitment to slow to justify longer study duration). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical response from baseline (time frame: At baseline and at approximately 2, 4, 8, 20 and 52 weeks after start of tofacitinib). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03772145, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.