Observational Study To Assess The Effectiveness Of Tofacitinib In Ulcerative Colitis In Clinical Practice In Sweden

NCT04338204

Last updated date
Study Location
SU/Sahlgrenska, Gastroenterologi & Hepatologi
Göteborg, , Göteborg, Sweden
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
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
 (submitted: April 4, 2020)
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:

  • 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.

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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2021