Brief Summary

This is a prospective observational study using data from an existing, ongoing National Swedish registry (SWIBREG). This study is designed to assess the effectiveness and treatment adherence of tofacitinib on clinical disease activity parameters in patients with ulcerative colitis in Swedish clinical practice. The study will also assess treatment adherence of tofacitinib using the Swedish Prescribed Drug Register.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

120

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach

1 country

17 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.5 years study duration

First Submitted

Initial submission to the registry

April 4, 2020

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed

5 months until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed

5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

5.5 years

First QC Date

April 4, 2020

Last Update Submit

March 11, 2026

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

Proportion of Participants in Remission as Measured by Partial Mayo Score
Clinical Remission is defined as a partial score of \<2 points with 0 points regarding rectal bleeding.
Week 52

Secondary Outcomes (47)

Proportion of Participants who are taking tofacitinib
Baseline, Weeks 8, 16, 52, 104
Proportion of Participants in Clinical Remission Based on Total Mayo Score
Weeks 8, 16, 52, and 104
Proportion of Participants in Clinical Response Based on Total Mayo Score
Weeks 8, 16, 52, and 104
Proportion of Participants in Clinical Remission Based on Partial Mayo Score
Weeks 8, 16, 52 and 104
Proportion of Participants in Clinical Response Based on Partial Mayo Score
Weeks 8, 16, 52 and 104
+42 more secondary outcomes

Study Arms (1)

Patients prescribed tofacitinib

Patients with a confirmed diagnosis of ulcerative colitis with confirmed active disease (biomarker or endoscopy) initiating tofacitinib as per the Swedish summary of product characteristics (SmPC).

Drug: tofacitinib

Interventions

tofacitinibDRUG

Observational study

Patients prescribed tofacitinib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with a confirmed diagnosis of ulcerative colitis, ≥18years of age, with confirmed active disease (biomarker or endoscopy) initiating tofacitinib as per the Swedish summary of product characteristics (SmPC)

You may qualify if:

The assignment of the patient to tofacitinib is not decided in advance by the protocol but falls within clinical practice and the prescription of the medicine is done according to the SmPC and is clearly separated from the decision to include the patient in the study.
The patient must sign the informed consent before enrollment in the study. The informed consent permits extraction of data from SWIBREG at baseline and during the duration of the study. For patients not registered in SWIBREG, they must complete all SWIBREG consents and registration at the time of treatment initiation. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Patients, male or female, must be 18 years old or above.

You may not qualify if:

The patient is enrolled in a clinical trial in which the treatment of ulcerative colitis is dictated by a study protocol. If the patient is participating in another ongoing observational study (non-interventional), the patient may be included in this observational study.
Patients that fulfill any of the contraindications according to the latest version of the SmPC. Any SmPC label updates will be communicated to all study sites.
For whatever reason the physician feels the patient unsuitable to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (17)

Ulf Eriksson

Alingsås, SE-441 33, Sweden

ACTIVE NOT RECRUITING

Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53

Borås, Sweden

ACTIVE NOT RECRUITING

Gävle Hospital

Gävle, 80324, Sweden

ACTIVE NOT RECRUITING

SU/Sahlgrenska, Gastroenterologi & Hepatologi

Gothenburg, Göteborg, Sweden

ACTIVE NOT RECRUITING

Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan

Jönköping, 55185, Sweden

ACTIVE NOT RECRUITING

Daniel Molin

Kristianstad, 29185, Sweden

RECRUITING

Shiprock Consulting AB,

Lidingö, Sweden

ACTIVE NOT RECRUITING

Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping

Linköping, 58185, Sweden

ACTIVE NOT RECRUITING

Region skåne, Skånes Universitetssjukhus

Malmo, 20501, Sweden

ACTIVE NOT RECRUITING

Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro

Örebro, 70185, Sweden

ACTIVE NOT RECRUITING

Stockholm Gastro Center

Stockholm, 11486, Sweden

ACTIVE NOT RECRUITING

Ersta Sjukhus, Medicinkliniken, Fjällgatan 44

Stockholm, 11691, Sweden

ACTIVE NOT RECRUITING

Karolinska Universitetssjukhuset i Solna, Eugeniavägen 3, B4-09,

Stockholm, 17176, Sweden

ACTIVE NOT RECRUITING

Danderyds Hospital

Stockholm, 18257, Sweden

ACTIVE NOT RECRUITING

Medicinkliniken, Umeås Universitetssjukhus

Umeå, 50985, Sweden

ACTIVE NOT RECRUITING

Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40

Uppsala, 75185, Sweden

ACTIVE NOT RECRUITING

Medicinmottagningen gastroenterologi, Västmanlands sjukhus

Västerås, 72189, Sweden

ACTIVE NOT RECRUITING

Related Publications (1)

Nyberg L, Halfvarson J, Soderling J, Olen O, Strid H, Hedin CRH, Jonsdottir SB, Hjortswang H, Jaghult S, Cappelleri JC, Henrohn D, Seddighzadeh M, Marsal J, Grip O; SWIBREG ODEN Study Group. Prospective observational study of tofacitinib in ulcerative colitis - analysis of clinical data, fatigue and health-related quality of life during the induction phase. Therap Adv Gastroenterol. 2025 Jun 16;18:17562848251343427. doi: 10.1177/17562848251343427. eCollection 2025.
PMID: 40535533DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 4, 2020

First Posted

April 8, 2020

Study Start

September 14, 2020

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing: Will not share

Locations

SE(17)

Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (47)

Study Arms (1)

Patients prescribed tofacitinib

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (17)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (47)

Study Arms (1)

Patients prescribed tofacitinib

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (17)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations