Xeljanz Special Investigation for Long-term Use in UC Patients

An observational study of Ulcerative Colitis, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice Read more about this study

Who is it for?: Ages 0 years and older
Conditions the study is for: Ulcerative Colitis
How many people: 2,016 participants
Where: 1 siteJapan
Study dates: 8 Jun 2018to 10 Nov 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 0 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: UC patients who were confirmed to have received Xeljanz after the approval date of dosage and administration of Xeljanz for UC patients

Who may be able to join

Patients with ulcerative colitis treated with XELJANZ
Patients naive to XELJANZ in the treatment of ulcerative colitis

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Japan1 site

Pfizer Local Country Office
Tokyo

Other trials in Japan

About this study

Official title: XELJANZ(REGISTERED) TABLETS 5 MG SPECIAL INVESTIGATION(INVESTIGATION OF LONG-TERM USE IN PATIENTS WITH ULCERATIVE COLITIS)

Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

Read the detailed description

This investigation aims to examine the safety and effectiveness of Xeljanz in post-marketing clinical settings when it is administered chronically to patients with ulcerative colitis, based on the approval conditions.

Conditions: Ulcerative Colitis
Keywords: Xeljanz, Ulcerative colitis, UC, Long-term
Medical subject headings: Colitis, Ulcerative

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Drug Reactions
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician.
Measured: 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 201810 Nov 2022

First posted22 Aug 2018
Study start8 Jun 2018
Primary completion10 Nov 2022
Study completion10 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: Case only
Time perspective: Prospective
Enrolment: 2,016 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03643211
Sponsor's protocol ID: A3921248
Status last verified: Sep 2024
First submitted: 21 Aug 2018
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Matsuoka K, Motoya S, Shinzaki S, Mikami Y, Adachi C, Arai S, Endo Y, Sato K, Yuasa H, Mizuno Y, Hisamatsu T. Post-marketing Surveillance of Tofacitinib in Patients With Ulcerative Colitis in Japan: A Post Hoc Analysis of Safety and Effectiveness by Prior Biologic Status. Crohns Colitis 360. 2025 Nov 22;7(4):otaf065. doi: 10.1093/crocol/otaf065. eCollection 2025 Oct.
PubMed 41425505
Matsuoka K, Motoya S, Yamamoto T, Matsuura M, Fujii T, Shinzaki S, Mikami Y, Arai S, Oshima J, Endo Y, Yuasa H, Hoshi M, Sato K, Hisamatsu T. Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data. J Gastroenterol. 2025 Aug;60(8):979-989. doi: 10.1007/s00535-025-02249-5. Epub 2025 Apr 21.
PubMed 40259041

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: XELJANZ(REGISTERED) TABLETS 5 MG SPECIAL INVESTIGATION(INVESTIGATION OF LONG-TERM USE IN PATIENTS WITH ULCERATIVE COLITIS)
ClinicalTrials.gov ID: NCT03643211
Acronym / sponsor ID: A3921248
Conditions: Ulcerative Colitis
Keywords: Xeljanz, Ulcerative colitis, UC, Long-term
Study type: Observational
Recruitment status: Completed
Enrolment: 2,016 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 8 Jun 2018 (actual)
Primary completion: 10 Nov 2022 (actual)
Study completion: 10 Nov 2022 (actual)
First posted: 22 Aug 2018 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 0 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: UC patients who were confirmed to have received Xeljanz after the approval date of dosage and administration of Xeljanz for UC patients

Key inclusion criteria (2 listed)

Patients with ulcerative colitis treated with XELJANZ
Patients naive to XELJANZ in the treatment of ulcerative colitis

Key exclusion criteria (1 listed)

None

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

Number of Participants With Adverse Drug Reactions
Time frame: 60 weeks
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician.

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
XELJANZ Tablets 5 mg (Tofacitinib Citrate)	2,016	1,995

Primary outcome: Number of Participants With Adverse Drug Reactions

Time frame: 60 weeks. Number. Unit: Participants

Measure	XELJANZ Tablets 5 mg (Tofacitinib Citrate) n = 1995
ADR	466
Serious ADR	46

Population analysed: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received XELJANZ at least once. Participants with contract violation/deficiency, invalid registration, no treatment information, and no adverse event information - no revisit were excluded.

Adverse events

Time frame: 60 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
XELJANZ Tablets 5 mg (Tofacitinib Citrate)	103 of 1,995 (5.2%)	586 of 1,995 (29.4%)	1 of 1,995

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41425505Matsuoka K, Motoya S, Shinzaki S, Mikami Y, Adachi C, Arai S, Endo Y, Sato K, Yuasa H, Mizuno Y, Hisamatsu T. Post-marketing Surveillance of Tofacitinib in Patients With Ulcerative Colitis in Japan: A Post Hoc Analysis of Safety and Effectiveness by Prior Biologic Status. Crohns Colitis 360. 2025 Nov 22;7(4):otaf065. doi: 10.1093/crocol/otaf065. eCollection 2025 Oct.
Derived from this study: PubMed 40259041Matsuoka K, Motoya S, Yamamoto T, Matsuura M, Fujii T, Shinzaki S, Mikami Y, Arai S, Oshima J, Endo Y, Yuasa H, Hoshi M, Sato K, Hisamatsu T. Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data. J Gastroenterol. 2025 Aug;60(8):979-989. doi: 10.1007/s00535-025-02249-5. Epub 2025 Apr 21.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Ulcerative Colitis

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RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
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RecruitingObservational study
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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.

Pfizer CT.gov Call Center study director

Pfizer

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 Pfizer at 1 site in Japan.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 8 Oct 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 Japan. 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?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Drug Reactions (time frame: 60 weeks). 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 NCT03643211, 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 8 Oct 2024.