Assessing the effectiveness of tofacitinib for ulcerative colitis in Sweden
Observational Study of Tofacitinib in Ulcerative Colitis in Sweden (ODEN)
Pfizer · NCT04338204
This study looks at how well tofacitinib works for people with ulcerative colitis in Sweden and how consistently they take the medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer (industry) |
| Drugs / interventions | tofacitinib |
| Locations | 17 sites (Alingsås and 16 other locations) |
| Trial ID | NCT04338204 on ClinicalTrials.gov |
What this trial studies
This observational study utilizes data from the National Swedish registry (SWIBREG) to evaluate how effective tofacitinib is in treating ulcerative colitis in clinical practice. It focuses on measuring clinical disease activity parameters and treatment adherence among patients prescribed tofacitinib. The study aims to gather real-world evidence on the medication's performance and adherence patterns in a Swedish population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with active ulcerative colitis who are prescribed tofacitinib as part of their clinical care.
Not a fit: Patients who do not have active ulcerative colitis or are not prescribed tofacitinib will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of tofacitinib, potentially improving treatment strategies for ulcerative colitis.
How similar studies have performed: While this study is observational and builds on existing data, similar studies have shown promise in assessing treatment adherence and effectiveness in chronic conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Alingsås and 16 other locations
- Ulf Eriksson — Alingsås, Sweden (ACTIVE_NOT_RECRUITING)
- Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53 — Borås, Sweden (ACTIVE_NOT_RECRUITING)
- Gävle Hospital — Gävle, Sweden (ACTIVE_NOT_RECRUITING)
- SU/Sahlgrenska, Gastroenterologi & Hepatologi — Gothenburg, Sweden (ACTIVE_NOT_RECRUITING)
- Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan — Jönköping, Sweden (ACTIVE_NOT_RECRUITING)
- Daniel Molin — Kristianstad, Sweden (RECRUITING)
- Shiprock Consulting AB, — Lidingö, Sweden (ACTIVE_NOT_RECRUITING)
- Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping — Linköping, Sweden (ACTIVE_NOT_RECRUITING)
- Region skåne, Skånes Universitetssjukhus — Malmö, Sweden (ACTIVE_NOT_RECRUITING)
- Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro — Örebro, Sweden (ACTIVE_NOT_RECRUITING)
- Stockholm Gastro Center — Stockholm, Sweden (ACTIVE_NOT_RECRUITING)
- Ersta Sjukhus, Medicinkliniken, Fjällgatan 44 — Stockholm, Sweden (ACTIVE_NOT_RECRUITING)
- Karolinska Universitetssjukhuset i Solna, Eugeniavägen 3, B4-09, — Stockholm, Sweden (ACTIVE_NOT_RECRUITING)
- Danderyds Hospital — Stockholm, Sweden (ACTIVE_NOT_RECRUITING)
- Medicinkliniken, Umeås Universitetssjukhus — Umeå, Sweden (ACTIVE_NOT_RECRUITING)
- Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40 — Uppsala, Sweden (ACTIVE_NOT_RECRUITING)
- Medicinmottagningen gastroenterologi, Västmanlands sjukhus — Västerås, Sweden (ACTIVE_NOT_RECRUITING)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis