Observational Study To Assess The Effectiveness Of Tofacitinib In Ulcerative Colitis In Clinical Practice In Sweden
NCT04338204
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- 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 2 weeks prior onset to the initiation of tofacitinib treatment.
- 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.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Observational Study To Assess The Effectiveness Of Tofacitinib In Ulcerative Colitis In Clinical Practice In Sweden | ||||
| Official Title | Observational Study of Tofacitinib in Ulcerative Colitis in Sweden (ODEN) | ||||
| Brief Summary | This is a prospective observational study using data from an existing, ongoing National Swedish registery (SWIBREG). This study is designed to assess the effectiveness of tofacitinib treatment on clinical disease activity parameters in patients with ulcerative colitis in Swedish clinical practice. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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) | ||||
| Condition | Ulcerative Colitis | ||||
| Intervention | Drug: tofacitinib
Observational study | ||||
| Study Groups/Cohorts | 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). Intervention: Drug: tofacitinib | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment | 120 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | September 15, 2024 | ||||
| Estimated Primary Completion Date | September 15, 2024 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
| ||||
| Listed Location Countries | Sweden | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04338204 | ||||
| Other Study ID Numbers | A3921366 ODEN ( Other Identifier: Alias Study Number ) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | February 2021 | ||||