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

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ClinicalTrials.gov Identifier: NCT04338204
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Ulcerative Colitis Drug: tofacitinib

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Tofacitinib in Ulcerative Colitis in Sweden (ODEN)
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : August 14, 2025
Estimated Study Completion Date : August 14, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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: Weeks 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: Weeks 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 ]
  39. Proportion of participants with no abdominal pain [ Time Frame: Baseline, Week 2 ]
  40. Proportion of participants with no bowel urgency [ Time Frame: Baseline, Week 2 ]
  41. Proportion of participants with reduction of ≥ 1 point from baseline rectal bleeding and stool frequency sub score [ Time Frame: Baseline, Week 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338204


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sweden
Ulf Eriksson Recruiting
Alingsås, Sweden, SE-441 33
Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53 Recruiting
Borås, Sweden
SU/Sahlgrenska, Gastroenterologi & Hepatologi Recruiting
Göteborg, Sweden, Göteborg
Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan Recruiting
Jönköping, Sweden, 55185
Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping Recruiting
Linköping, Sweden, 58185
Region skåne, Skånes Universitetssjukhus Recruiting
Malmö, Sweden, 20501
Stockholm Gastro Center Recruiting
Stockholm, Sweden, 11486
Ersta Sjukhus, Medicinkliniken, Fjällgatan 44 Recruiting
Stockholm, Sweden, 11691
Danderyds Hospital Recruiting
Stockholm, Sweden, 18257
Medicinkliniken, Umeås Universitetssjukhus Recruiting
Umeå, Sweden, 50985
Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40 Recruiting
Uppsala, Sweden, 75185
Medicinmottagningen gastroenterologi, Västmanlands sjukhus Recruiting
Västerås, Sweden, 72189
Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro Recruiting
Örebro, Sweden, 70185
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04338204    
Other Study ID Numbers: A3921366
ODEN ( Other Identifier: Alias Study Number )
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action