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

June 1, 2026 updated by: Pfizer

OBSERVATIONAL STUDY OF TOFACITINIB IN ULCERATIVE COLITIS IN SWEDEN (ODEN)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Alingsås, Sweden, SE-441 33
        • Ulf Eriksson
      • Borås, Sweden
        • Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53
      • Gothenburg, Sweden, Göteborg
        • SU/Sahlgrenska, Gastroenterologi & Hepatologi
      • Gävle, Sweden, 80324
        • Gävle Hospital
      • Jönköping, Sweden, 55185
        • Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan
      • Kristianstad, Sweden, 29185
        • Daniel Molin
      • Lidingö, Sweden
        • Shiprock Consulting AB,
      • Linköping, Sweden, 58185
        • Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping
      • Malmö, Sweden, 20501
        • Region skåne, Skånes Universitetssjukhus
      • Stockholm, Sweden, 11486
        • Stockholm Gastro Center
      • Stockholm, Sweden, 11691
        • Ersta Sjukhus, Medicinkliniken, Fjällgatan 44
      • Stockholm, Sweden, 17176
        • Karolinska Universitetssjukhuset i Solna, Eugeniavägen 3, B4-09,
      • Stockholm, Sweden, 18257
        • Danderyds hospital
      • Umeå, Sweden, 50985
        • Medicinkliniken, Umeås Universitetssjukhus
      • Uppsala, Sweden, 75185
        • Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40
      • Västerås, Sweden, 72189
        • Medicinmottagningen gastroenterologi, Västmanlands sjukhus
      • Örebro, Sweden, 70185
        • Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-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)

Description

Inclusion Criteria:

  • 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.
  • The patient must have active disease as confirmed by fecal calprotectin >250 mg/kg or endoscopic assessment corresponding to a Mayo endoscopic subscore ≥2 not more than 4 weeks prior onset to the initiation of tofacitinib treatment. This inclusion criteria applies also to patients that have already been enrolled in the study.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Observational study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants in Remission as Measured by Partial Mayo Score
Time Frame: Week 52
Clinical Remission is defined as a partial score of <2 points with 0 points regarding rectal bleeding.
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants who are taking tofacitinib
Time Frame: Baseline, Weeks 8, 16, 52, 104
Baseline, Weeks 8, 16, 52, 104
Proportion of Participants in Clinical Remission Based on Total Mayo Score
Time Frame: Weeks 8, 16, 52, and 104
Clinical Remission is defined as a total Mayo score of ≤2 points with no individual subscore exceeding 1 point, with 0 points regarding rectal bleeding.
Weeks 8, 16, 52, and 104
Proportion of Participants in Clinical Response Based on Total Mayo Score
Time Frame: Weeks 8, 16, 52, and 104
Clinical Response is defined as a total Mayo score decrease of ≥3 points and a decrease of ≥30% from baseline, with a decrease of ≥1 point on the rectal bleeding subscore or an absolute rectal bleeding score of ≤1
Weeks 8, 16, 52, and 104
Proportion of Participants in Clinical Remission Based on Partial Mayo Score
Time Frame: Weeks 8, 16, 52 and 104
Clinical Remission is defined as a partial Mayo score <2 points with 0 points regarding rectal bleeding.
Weeks 8, 16, 52 and 104
Proportion of Participants in Clinical Response Based on Partial Mayo Score
Time Frame: Weeks 8, 16, 52 and 104
Clinical Response is defined as a partial Mayo score decrease of ≥2 points and reduction of at least 25% in partial Mayo (pMayo) score from baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point
Weeks 8, 16, 52 and 104
Change from Baseline in Total Mayo Score
Time Frame: Baseline, Weeks 8, 16, 52, and 104
Baseline, Weeks 8, 16, 52, and 104
Change From Baseline In Partial Mayo Score
Time Frame: Baseline, Weeks 8, 16, 52 and 104
Baseline, Weeks 8, 16, 52 and 104
Change From Baseline In Level of Fecal Calprotectin (f-calprotectin)
Time Frame: Baseline, Weeks 8, 16, 52 and 104
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Baseline, Weeks 8, 16, 52 and 104
Proportion of Responders defined by a Fecal Calprotectin (f-calprotectin) Reduction of ≥50%, ≥75% or ≥90%
Time Frame: Weeks 8, 16, 52, and 104
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Weeks 8, 16, 52, and 104
Change from Baseline of C-Reactive Protein (CRP)
Time Frame: Baseline, Weeks 8, 16, 52, and 104
Baseline, Weeks 8, 16, 52, and 104
Proportion of Participants In Sustained Remission (Partial Mayo score)
Time Frame: Week 8 To Weeks 16, 52 and 104
Week 8 To Weeks 16, 52 and 104
Proportion of Participants In Sustained Remission (Partial Mayo score)
Time Frame: Week 16 To Weeks 52 and 104
Week 16 To Weeks 52 and 104
Proportion of Participants in Sustained Steroid Free Remission (Partial Mayo Score) (for all patients and for those treated with corticosteroids at baseline)
Time Frame: Weeks 16 through 52 and at Week 104
Weeks 16 through 52 and at Week 104
Proportion of Participants in Endoscopic Remission, Mucosal Healing or Endoscopic Response
Time Frame: Week 8, 16, 52 and 104
Endoscopic remission is defined as a subscore of 0. Mucosal healing is defined as a subscore of 0-1. Endoscopic response is defined as a subscore reduction from baseline of ≥1.
Week 8, 16, 52 and 104
Proportion of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response
Time Frame: Week 8 to Week 16, 52 and 104
Endoscopic remission is defined as a subscore of 0. Mucosal healing is defined as a subscore of 0-1. Endoscopic response is defined as a subscore reduction from baseline of ≥1.
Week 8 to Week 16, 52 and 104
Proportion of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response
Time Frame: Week 16 to 52 and at Week 104
Endoscopic remission is defined as a subscore of 0. Mucosal healing is defined as a subscore of 0-1. Endoscopic response is defined as a subscore reduction from baseline of ≥1.
Week 16 to 52 and at Week 104
Proportion of Participants in Sustained Steroid Free Remission (Partial Mayo Score) (For All Participants and for Those Treated With Corticosteroids at Baseline) and Endoscopic Remission, Mucosal Healing or Endoscopic Response
Time Frame: Week 16 to 52 and 104
Endoscopic remission is defined as a subscore of 0. Mucosal healing is defined as a subscore of 0-1. Endoscopic response is defined as a subscore reduction from baseline of ≥1.
Week 16 to 52 and 104
Change From Baseline In Inflammatory Bowel Disease Fatigue (IBD-F) Score
Time Frame: Baseline, Weeks 8, 16, 52 and 104
Baseline, Weeks 8, 16, 52 and 104
Change From Baseline In EuroQol 5 Dimensions 5 Levels (EQ5D-5L)
Time Frame: Baseline, Weeks 8, 16, 52, and 104
Baseline, Weeks 8, 16, 52, and 104
Change From Baseline In Short Health Scale (SHS)
Time Frame: Baseline, Weeks 8, 16, 52 and 104
Baseline, Weeks 8, 16, 52 and 104
Proportion of Participants Who Had a Colectomy
Time Frame: Weeks 8, 16, 52, and 104
Weeks 8, 16, 52, and 104
Comparison of Response and Remission (Partial Mayo Score) Based on the Extent of Ulcerative Colitis According To the Montreal Classification
Time Frame: Weeks 8, 16, 52 and 104
Weeks 8, 16, 52 and 104
Proportion of Participants In Sustained Remission (Total Mayo score)
Time Frame: Week 16 To Weeks 52 and 104
Week 16 To Weeks 52 and 104
Proportion of Participants In Sustained Remission (Total Mayo score)
Time Frame: Week 8 To Weeks 16, 52 and 104
Week 8 To Weeks 16, 52 and 104
Proportion of Participants in Sustained Steroid Free Remission (Total Mayo Score) (For All Participants and for Those Treated With Corticosteroids at Baseline) and Endoscopic Remission, Mucosal Healing or Endoscopic Response
Time Frame: Week 16 to 52 and 104
Endoscopic remission is defined as a subscore of 0. Mucosal healing is defined as a subscore of 0-1. Endoscopic response is defined as a subscore reduction from baseline of ≥1.
Week 16 to 52 and 104
Proportion of Participants in Sustained Steroid Free Remission (Total Mayo Score) (for all patients and for those treated with corticosteroids at baseline)
Time Frame: Weeks 16 through 52 and at Week 104
Weeks 16 through 52 and at Week 104
Comparison of Response and Remission (Total Mayo Score) Based on the Extent of Ulcerative Colitis According To the Montreal Classification
Time Frame: Weeks 8, 16, 52 and 104
Weeks 8, 16, 52 and 104
Proportion of participants reaching f-calprotectin below 250 mg/kg of those that had f-calprotectin above 250 mg/kg at baseline
Time Frame: Baseline, week 8, 16, 52 and 104
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Baseline, week 8, 16, 52 and 104
Portion of participants with dose change of tofacitinib
Time Frame: Week 8, 16, 52 and 104
Week 8, 16, 52 and 104
Portion of participants with a termination of tofacitinib
Time Frame: Week 8, 16, 52 and 104
Week 8, 16, 52 and 104
Portion of participants with dose and dose changes of tofacitinib and corticosteroids
Time Frame: Week 8, 16, 52 and 104
Week 8, 16, 52 and 104
Proportion of particpants with changes in rectal bleeding and stool frequency
Time Frame: Baseline, Week 2
Proportion of patients with improvement in rectal bleeding and stool frequency with a change in baseline sub score 1
Baseline, Week 2
Proportion of participants with changes in EQ5D and SHS
Time Frame: Baseline, Week 2
Baseline, Week 2
Proportion of particpants with rectal bleeding and stool frequency sub score indicative of mild disease
Time Frame: Baseline, Week 2
Baseline, Week 2
Proportion of participants with stool frequency and rectal bleeding subscore of 0
Time Frame: Baseline, Week 2
Baseline, Week 2
Proportion of participants with reduction of ≥ 1 point from baseline rectal bleeding and stool frequency sub score
Time Frame: Baseline, Week 2
Baseline, Week 2
Proportion of Participants in Steroid-Free Clinical Remission
Time Frame: Baseline, weeks 8, 16, 52, and 104
Steroid-Free Clinical Remission is defined by a total Mayo Score who did not require any corticosteroid treatment during the period ≥4 weeks prior to the visit (for all patients and for those treated with corticosteroids at baseline)
Baseline, weeks 8, 16, 52, and 104
Proportion of Participants in Steroid-Free Clinical Remission
Time Frame: Baseline, weeks 8, 16, 52, and 104
Steroid-Free Clinical Remission is defined by a partial Mayo Score who did not require any corticosteroid treatment during the period ≥4 weeks prior to the visit (for all patients and for those treated with corticosteroids at baseline)
Baseline, weeks 8, 16, 52, and 104
Proportion of participants with mild abdominal pain
Time Frame: Baseline, week 2, 8, 16, 52 and 104
Baseline, week 2, 8, 16, 52 and 104
Proportion of participants with no abdominal pain
Time Frame: Baseline, week 2, 8, 16, 52 and 104
Baseline, week 2, 8, 16, 52 and 104
Proportion of participants with no bowel urgency
Time Frame: Baseline, Weeks 2, 8, 16, 52 and 104.
Baseline, Weeks 2, 8, 16, 52 and 104.
Proportion of patients achieving symptomatic remission
Time Frame: Baseline, weeks 2, 8, 16, 52 and 104.
Symptomatic remission is defined as a total sum of 0 of the to Mayo sub-scores stool frequency(SF) and rectal bleeding (RB)
Baseline, weeks 2, 8, 16, 52 and 104.
Proportion of patients achieving symptomatic remission stratified on steroid use at baseline or not.
Time Frame: Baseline, weeks 2, 8, 16, 52 and 104
Baseline, weeks 2, 8, 16, 52 and 104
Proportion of patients achieving symptomatic response
Time Frame: Baseline, weeks 2, 8, 16, 52 and 104
Symptomatic response is defined as a decrease of at least 50% of the sum of the Mayo-sub-scores stool frequency (SF) and rectal bleeding (RB).
Baseline, weeks 2, 8, 16, 52 and 104
Proportion of patients achieving symptomatic response stratified on steroid use at baseline
Time Frame: Baseline, weeks 2, 8, 16, 52 and 104
Baseline, weeks 2, 8, 16, 52 and 104
Proportion of patients in steroid-free clinical remission (pMayo and full Mayo score)stratified based on steroid use at baseline or not.
Time Frame: Baseline, weeks 8, 16, 52 and 104
Steroid-Free Clinical Remission is defined by a partial Mayo Score who did not require any corticosteroid treatment during the period ≥4 weeks prior to the visit (for all patients and for those treated with corticosteroids at baseline)
Baseline, weeks 8, 16, 52 and 104
Change from baseline in bowel urgency (as measured by SCCAI)
Time Frame: Weeks 2, 8, 16, 52 and 104
SCCAI is the Simple Clinical Colitis Activity Index bowel urgency sub-score used to assess the bowel urgency.
Weeks 2, 8, 16, 52 and 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3921366
  • ODEN (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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