Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGOBSERVATIONAL

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

Observational Study of Tofacitinib in Ulcerative Colitis in Sweden (ODEN)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form before enrollment in the study. The willing to sign a consent form 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

tofacitinib

Observational study

Locations (17)

Ulf Eriksson
Alingsås, Sweden
Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53
Borås, Sweden
Gävle Hospital
Gävle, Sweden
SU/Sahlgrenska, Gastroenterologi & Hepatologi
Gothenburg, Sweden
Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan
Jönköping, Sweden
Daniel Molin
Kristianstad, Sweden
Shiprock Consulting AB,
Lidingö, Sweden
Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping
Linköping, Sweden
Region skåne, Skånes Universitetssjukhus
Malmo, Sweden
Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro
Örebro, Sweden
Stockholm Gastro Center
Stockholm, Sweden
Ersta Sjukhus, Medicinkliniken, Fjällgatan 44
Stockholm, Sweden
Karolinska Universitetssjukhuset i Solna, Eugeniavägen 3, B4-09,
Stockholm, Sweden
Danderyds Hospital
Stockholm, Sweden
Medicinkliniken, Umeås Universitetssjukhus
Umeå, Sweden
Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40
Uppsala, Sweden
Medicinmottagningen gastroenterologi, Västmanlands sjukhus
Västerås, Sweden