Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04338204
Other study ID # A3921366
Secondary ID ODEN
Status Recruiting
Phase
First received
Last updated
Start date September 18, 2020
Est. completion date August 14, 2026

Study information

Verified date April 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date August 14, 2026
Est. primary completion date August 14, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
tofacitinib
Observational study

Locations

Country Name City State
Sweden Ulf Eriksson Alingsås
Sweden Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53 Borås
Sweden Gävle Hospital Gävle
Sweden SU/Sahlgrenska, Gastroenterologi & Hepatologi Göteborg
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 Malmö
Sweden Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro Örebro
Sweden Capio S:t Görans Sjukhus, S:t Göransplan 1 Stockholm
Sweden Danderyds Hospital Stockholm
Sweden Ersta Sjukhus, Medicinkliniken, Fjällgatan 44 Stockholm
Sweden Karolinska Universitetssjukhuset i Solna, Eugeniavägen 3, B4-09, Stockholm
Sweden Stockholm Gastro Center Stockholm
Sweden Medicinkliniken, Umeås Universitetssjukhus Umeå
Sweden Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40 Uppsala
Sweden Medicinmottagningen gastroenterologi, Västmanlands sjukhus Västerås

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Participants in Remission as Measured by Partial Mayo Score Clinical Remission is defined as a partial score of <2 points with 0 points regarding rectal bleeding. Week 52
Secondary Proportion of Participants who are taking tofacitinib Baseline, Weeks 8, 16, 52, 104
Secondary Proportion of Participants in Clinical Remission Based on Total Mayo Score 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. Weeks 8, 16, 52, and 104
Secondary Proportion of Participants in Clinical Response Based on Total Mayo Score 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 Weeks 8, 16, 52, and 104
Secondary Proportion of Participants in Clinical Remission Based on Partial Mayo Score Clinical Remission is defined as a partial Mayo score <2 points with 0 points regarding rectal bleeding. Weeks 8, 16, 52 and 104
Secondary Proportion of Participants in Clinical Response Based on Partial Mayo Score 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 Weeks 8, 16, 52 and 104
Secondary Proportion of Participants in Steroid-Free Clinical Remission 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) Weeks 16, 52, and 104
Secondary Change from Baseline in Total Mayo Score Baseline, Weeks 8, 16, 52, and 104
Secondary Change From Baseline In Partial Mayo Score Baseline, Weeks 8, 16, 52 and 104
Secondary Change From Baseline In Level of Fecal Calprotectin (f-calprotectin) 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. Baseline, Weeks 8, 16, 52 and 104
Secondary Proportion of Responders defined by a Fecal Calprotectin (f-calprotectin) Reduction of =50%, =75% or =90% 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. Weeks 8, 16, 52, and 104
Secondary Change from Baseline of C-Reactive Protein (CRP) Baseline, Weeks 8, 16, 52, and 104
Secondary Proportion of Participants In Sustained Remission (Partial Mayo score) Week 8 To Weeks 16, 52 and 104
Secondary Proportion of Participants In Sustained Remission (Partial Mayo score) Week 16 To Weeks 52 and 104
Secondary Proportion of Participants in Sustained Steroid Free Remission (Partial Mayo Score) (for all patients and for those treated with corticosteroids at baseline) Weeks 16 through 52 and at Week 104
Secondary Proportion of Participants in Endoscopic Remission, Mucosal Healing or Endoscopic Response 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. Week 8, 16, 52 and 104
Secondary Proportion of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response 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. Week 8 to Week 16, 52 and 104
Secondary Proportion of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response 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. Week 16 to 52 and at Week 104
Secondary 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 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. Week 16 to 52 and 104
Secondary Change From Baseline In Inflammatory Bowel Disease Fatigue (IBD-F) Score Baseline, Weeks 8, 16, 52 and 104
Secondary Change From Baseline In EuroQol 5 Dimensions 5 Levels (EQ5D-5L) Baseline, Weeks 8, 16, 52, and 104
Secondary Change From Baseline In Short Health Scale (SHS) Baseline, Weeks 8, 16, 52 and 104
Secondary Proportion of Participants Who Had a Colectomy Weeks 8, 16, 52, and 104
Secondary Comparison of Response and Remission (Partial Mayo Score) Based on the Extent of Ulcerative Colitis According To the Montreal Classification Weeks 8, 16, 52 and 104
Secondary Proportion of Participants In Sustained Remission (Total Mayo score) Week 16 To Weeks 52 and 104
Secondary Proportion of Participants In Sustained Remission (Total Mayo score) Week 8 To Weeks 16, 52 and 104
Secondary 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 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. Week 16 to 52 and 104
Secondary Proportion of Participants in Sustained Steroid Free Remission (Total Mayo Score) (for all patients and for those treated with corticosteroids at baseline) Weeks 16 through 52 and at Week 104
Secondary Comparison of Response and Remission (Total Mayo Score) Based on the Extent of Ulcerative Colitis According To the Montreal Classification Weeks 8, 16, 52 and 104
Secondary Proportion of Participants in Steroid-Free Clinical Remission 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) Weeks 16, 52, and 104
Secondary Proportion of participants reaching f-calprotectin below 250 mg/kg of those that had f-calprotectin above 250 mg/kg at baseline 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. Baseline, week 8, 16, 52 and 104
Secondary Portion of participants with dose change of tofacitinib Week 8, 16, 52 and 104
Secondary Portion of participants with a termination of tofacitinib Week 8, 16, 52 and 104
Secondary Portion of participants with dose and dose changes of tofacitinib and corticosteroids Week 8, 16, 52 and 104
Secondary Proportion of particpants with changes in rectal bleeding and stool frequency Proportion of patients with improvement in rectal bleeding and stool frequency with a change in baseline sub score 1 Baseline, Week 2
Secondary Proportion of participants with changes in EQ5D and SHS Baseline, Week 2
Secondary Proportion of particpants with rectal bleeding and stool frequency sub score indicative of mild disease Baseline, Week 2
Secondary Proportion of participants with stool frequency and rectal bleeding subscore of 0 Baseline, Week 2
Secondary Proportion of participants with mild abdominal pain Baseline, Week 2
Secondary Proportion of participants with no abdominal pain Baseline, Week 2
Secondary Proportion of participants with no bowel urgency Baseline, Week 2
Secondary Proportion of participants with reduction of = 1 point from baseline rectal bleeding and stool frequency sub score Baseline, Week 2
See also
  Status Clinical Trial Phase
Recruiting NCT05702879 - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting NCT05953402 - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Recruiting NCT03950232 - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT03124121 - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels Phase 4
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Withdrawn NCT04209556 - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis Phase 2
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Recruiting NCT04398550 - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis N/A
Recruiting NCT04314375 - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis Phase 4
Active, not recruiting NCT04857112 - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis Phase 2
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting NCT04033445 - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2/Phase 3
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting NCT06221995 - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Completed NCT03760003 - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis Phase 2
Not yet recruiting NCT05539625 - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis Phase 2