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Completed

NCT Number: NCT04338204

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ulf Eriksson, Alingsås, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tofacitinib

Drug

Observational study

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of Participants who are taking tofacitinib

    Time frame: Baseline, Weeks 8, 16, 52, 104

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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)

  7. Change from Baseline in Total Mayo Score

    Time frame: Baseline, Weeks 8, 16, 52, and 104

  8. Change From Baseline In Partial Mayo Score

    Time frame: Baseline, Weeks 8, 16, 52 and 104

  9. 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.

  10. 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.

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

    Time frame: Baseline, Weeks 8, 16, 52, and 104

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

    Time frame: Week 8 To Weeks 16, 52 and 104

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

    Time frame: 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)

    Time frame: Weeks 16 through 52 and at Week 104

  15. 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.

  16. 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.

  17. 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.

  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

    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.

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

    Time frame: Baseline, Weeks 8, 16, 52 and 104

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

    Time frame: Baseline, Weeks 8, 16, 52, and 104

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

    Time frame: Baseline, Weeks 8, 16, 52 and 104

  22. Proportion of Participants Who Had a Colectomy

    Time frame: 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

    Time frame: Weeks 8, 16, 52 and 104

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

    Time frame: Week 16 To Weeks 52 and 104

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

    Time frame: 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

    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.

  27. 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

  28. 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

  29. 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)

  30. 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.

  31. Portion of participants with dose change of tofacitinib

    Time frame: Week 8, 16, 52 and 104

  32. Portion of participants with a termination of tofacitinib

    Time frame: Week 8, 16, 52 and 104

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

    Time frame: Week 8, 16, 52 and 104

  34. 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

  35. Proportion of participants with changes in EQ5D and SHS

    Time frame: Baseline, Week 2

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

    Time frame: Baseline, Week 2

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

    Time frame: Baseline, Week 2

  38. Proportion of participants with mild abdominal pain

    Time frame: Baseline, week 2, 8, 16, 52 and 104

  39. Proportion of participants with no abdominal pain

    Time frame: Baseline, week 2, 8, 16, 52 and 104

  40. Proportion of participants with no bowel urgency

    Time frame: 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

    Time frame: Baseline, Week 2

  42. 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)

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

    Time frame: Baseline, weeks 2, 8, 16, 52 and 104

  44. 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).

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

    Time frame: 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.

    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)

  47. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: ODEN

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2020
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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