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Ulcerative ColitisODENNCT04338204

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

An observational study of Ulcerative Colitis, run by Pfizer at 17 sites in Sweden.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
tofacitinib
How many people
102 participants
Where
17 sitesSweden
Study dates
14 Sep 2020to 30 Sep 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Sweden17 sites

  • Ulf Eriksson

    Alingsås, SE-441 33

  • Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53

    Borås

  • Gävle Hospital

    Gävle, 80324

  • SU/Sahlgrenska, Gastroenterologi & Hepatologi

    Gothenburg, Göteborg

  • Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan

    Jönköping, 55185

  • Daniel Molin

    Kristianstad, 29185

  • Shiprock Consulting AB,

    Lidingö

  • Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping

    Linköping, 58185

  • Region skåne, Skånes Universitetssjukhus

    Malmö, 20501

  • Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro

    Örebro, 70185

  • Stockholm Gastro Center

    Stockholm, 11486

  • Ersta Sjukhus, Medicinkliniken, Fjällgatan 44

    Stockholm, 11691

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

    Stockholm, 17176

  • Danderyds Hospital

    Stockholm, 18257

  • Medicinkliniken, Umeås Universitetssjukhus

    Umeå, 50985

  • Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40

    Uppsala, 75185

  • Medicinmottagningen gastroenterologi, Västmanlands sjukhus

    Västerås, 72189

Other trials in Sweden

About this study

Official title: 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.

Being tested
tofacitinib
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tofacitinibDrug

    Observational study

Study groups in NCT04338204
Study groupRoleWhat they receive
Patients prescribed tofacitinibPatients 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).
Receives: Drug: tofacitinib

What is being measured

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

  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.

    Measured: Week 52

Secondary outcomes (47)

  1. Proportion of Participants who are taking tofacitinib

    Measured: Baseline, Weeks 8, 16, 52, 104

  2. Proportion of Participants in Clinical Remission Based on Total Mayo Score

    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.

    Measured: Weeks 8, 16, 52, and 104

  3. Proportion of Participants in Clinical Response Based on Total Mayo Score

    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

    Measured: Weeks 8, 16, 52, and 104

  4. Proportion of Participants in Clinical Remission Based on Partial Mayo Score

    Clinical Remission is defined as a partial Mayo score <2 points with 0 points regarding rectal bleeding.

    Measured: Weeks 8, 16, 52 and 104

  5. Proportion of Participants in Clinical Response Based on Partial Mayo Score

    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

    Measured: Weeks 8, 16, 52 and 104

  6. Proportion of Participants in Steroid-Free Clinical Remission

    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)

    Measured: Baseline, weeks 8, 16, 52, and 104

  7. Change from Baseline in Total Mayo Score

    Measured: Baseline, Weeks 8, 16, 52, and 104

  8. Change From Baseline In Partial Mayo Score

    Measured: Baseline, Weeks 8, 16, 52 and 104

  9. Change From Baseline In Level of Fecal Calprotectin (f-calprotectin)

    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.

    Measured: Baseline, Weeks 8, 16, 52 and 104

  10. Proportion of Responders defined by a Fecal Calprotectin (f-calprotectin) Reduction of ≥50%, ≥75% or ≥90%

    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.

    Measured: Weeks 8, 16, 52, and 104

  11. Change from Baseline of C-Reactive Protein (CRP)

    Measured: Baseline, Weeks 8, 16, 52, and 104

  12. Proportion of Participants In Sustained Remission (Partial Mayo score)

    Measured: Week 8 To Weeks 16, 52 and 104

  13. Proportion of Participants In Sustained Remission (Partial Mayo score)

    Measured: Week 16 To Weeks 52 and 104

  14. Proportion of Participants in Sustained Steroid Free Remission (Partial Mayo Score) (for all patients and for those treated with corticosteroids at baseline)

    Measured: Weeks 16 through 52 and at Week 104

  15. Proportion of Participants in Endoscopic Remission, Mucosal Healing or Endoscopic Response

    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.

    Measured: Week 8, 16, 52 and 104

  16. Proportion of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response

    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.

    Measured: Week 8 to Week 16, 52 and 104

  17. Proportion of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response

    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.

    Measured: Week 16 to 52 and at Week 104

  18. 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

    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.

    Measured: Week 16 to 52 and 104

  19. Change From Baseline In Inflammatory Bowel Disease Fatigue (IBD-F) Score

    Measured: Baseline, Weeks 8, 16, 52 and 104

  20. Change From Baseline In EuroQol 5 Dimensions 5 Levels (EQ5D-5L)

    Measured: Baseline, Weeks 8, 16, 52, and 104

  21. Change From Baseline In Short Health Scale (SHS)

    Measured: Baseline, Weeks 8, 16, 52 and 104

  22. Proportion of Participants Who Had a Colectomy

    Measured: Weeks 8, 16, 52, and 104

  23. Comparison of Response and Remission (Partial Mayo Score) Based on the Extent of Ulcerative Colitis According To the Montreal Classification

    Measured: Weeks 8, 16, 52 and 104

  24. Proportion of Participants In Sustained Remission (Total Mayo score)

    Measured: Week 16 To Weeks 52 and 104

  25. Proportion of Participants In Sustained Remission (Total Mayo score)

    Measured: Week 8 To Weeks 16, 52 and 104

  26. 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

    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.

    Measured: Week 16 to 52 and 104

  27. Proportion of Participants in Sustained Steroid Free Remission (Total Mayo Score) (for all patients and for those treated with corticosteroids at baseline)

    Measured: Weeks 16 through 52 and at Week 104

  28. Comparison of Response and Remission (Total Mayo Score) Based on the Extent of Ulcerative Colitis According To the Montreal Classification

    Measured: Weeks 8, 16, 52 and 104

  29. Proportion of Participants in Steroid-Free Clinical Remission

    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)

    Measured: Baseline, weeks 8, 16, 52, and 104

  30. Proportion of participants reaching f-calprotectin below 250 mg/kg of those that had f-calprotectin above 250 mg/kg at baseline

    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.

    Measured: Baseline, week 8, 16, 52 and 104

  31. Portion of participants with dose change of tofacitinib

    Measured: Week 8, 16, 52 and 104

  32. Portion of participants with a termination of tofacitinib

    Measured: Week 8, 16, 52 and 104

  33. Portion of participants with dose and dose changes of tofacitinib and corticosteroids

    Measured: Week 8, 16, 52 and 104

  34. Proportion of particpants with changes in rectal bleeding and stool frequency

    Proportion of patients with improvement in rectal bleeding and stool frequency with a change in baseline sub score 1

    Measured: Baseline, Week 2

  35. Proportion of participants with changes in EQ5D and SHS

    Measured: Baseline, Week 2

  36. Proportion of particpants with rectal bleeding and stool frequency sub score indicative of mild disease

    Measured: Baseline, Week 2

  37. Proportion of participants with stool frequency and rectal bleeding subscore of 0

    Measured: Baseline, Week 2

  38. Proportion of participants with mild abdominal pain

    Measured: Baseline, week 2, 8, 16, 52 and 104

  39. Proportion of participants with no abdominal pain

    Measured: Baseline, week 2, 8, 16, 52 and 104

  40. Proportion of participants with no bowel urgency

    Measured: Baseline, Weeks 2, 8, 16, 52 and 104.

  41. Proportion of participants with reduction of ≥ 1 point from baseline rectal bleeding and stool frequency sub score

    Measured: Baseline, Week 2

  42. Proportion of patients achieving symptomatic remission

    Symptomatic remission is defined as a total sum of 0 of the to Mayo sub-scores stool frequency(SF) and rectal bleeding (RB)

    Measured: Baseline, weeks 2, 8, 16, 52 and 104.

  43. Proportion of patients achieving symptomatic remission stratified on steroid use at baseline or not.

    Measured: Baseline, weeks 2, 8, 16, 52 and 104

  44. Proportion of patients achieving symptomatic response

    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).

    Measured: Baseline, weeks 2, 8, 16, 52 and 104

  45. Proportion of patients achieving symptomatic response stratified on steroid use at baseline

    Measured: Baseline, weeks 2, 8, 16, 52 and 104

  46. Proportion of patients in steroid-free clinical remission (pMayo and full Mayo score)stratified based on steroid use at baseline or not.

    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)

    Measured: Baseline, weeks 8, 16, 52 and 104

  47. Change from baseline in bowel urgency (as measured by SCCAI)

    SCCAI is the Simple Clinical Colitis Activity Index bowel urgency sub-score used to assess the bowel urgency.

    Measured: Weeks 2, 8, 16, 52 and 104

Timeline

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

  1. First posted8 Apr 2020
  2. Study start14 Sep 2020
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

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
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04338204
Sponsor's protocol ID
A3921366
Other IDs
ODEN
Acronym
ODEN
Status last verified
Jun 2026
First submitted
4 Apr 2020
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
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

  • 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. Ther Adv Gastroenterol. 2025 Jun 16;18:17562848251343427. doi: 10.1177/17562848251343427. eCollection 2025.

    PubMed 40535533

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by Pfizer at 17 sites in Sweden.

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 4 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: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of Participants in Remission as Measured by Partial Mayo Score (time frame: Week 52). 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 NCT04338204, which also lists 1 linked publication.

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 3 Jun 2026.

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