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| ID | Type | Description | Link |
|---|---|---|---|
| ODEN | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tofacitinib | Drug | Observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants who are taking tofacitinib | Baseline, Weeks 8, 16, 52, 104 | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulf Eriksson | Alingsås | SE-441 33 | Sweden | |||
| Medicinkliniken, Södra Älvsborgs Sjukhus Borås, Brämhultsvägen 53 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40535533 | Derived | Nyberg L, Halfvarson J, Soderling J, Olen O, Strid H, Hedin CRH, Jonsdottir SB, Hjortswang H, Jaghult S, Cappelleri JC, Henrohn D, Seddighzadeh M, Marsal J, Grip O; SWIBREG ODEN Study Group. Prospective observational study of tofacitinib in ulcerative colitis - analysis of clinical data, fatigue and health-related quality of life during the induction phase. Ther Adv Gastroenterol. 2025 Jun 16;18:17562848251343427. doi: 10.1177/17562848251343427. eCollection 2025. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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/data\_requests.
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| Weeks 8, 16, 52, and 104 |
| 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 |
| 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 |
| 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 |
| 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) | Baseline, weeks 8, 16, 52, and 104 |
| Change from Baseline in Total Mayo Score | Baseline, Weeks 8, 16, 52, and 104 |
| Change From Baseline In Partial Mayo Score | Baseline, Weeks 8, 16, 52 and 104 |
| 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 |
| 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 |
| Change from Baseline of C-Reactive Protein (CRP) | Baseline, Weeks 8, 16, 52, and 104 |
| Proportion of Participants In Sustained Remission (Partial Mayo score) | Week 8 To Weeks 16, 52 and 104 |
| Proportion of Participants In Sustained Remission (Partial Mayo score) | Week 16 To Weeks 52 and 104 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change From Baseline In Inflammatory Bowel Disease Fatigue (IBD-F) Score | Baseline, Weeks 8, 16, 52 and 104 |
| Change From Baseline In EuroQol 5 Dimensions 5 Levels (EQ5D-5L) | Baseline, Weeks 8, 16, 52, and 104 |
| Change From Baseline In Short Health Scale (SHS) | Baseline, Weeks 8, 16, 52 and 104 |
| Proportion of Participants Who Had a Colectomy | Weeks 8, 16, 52, and 104 |
| 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 |
| Proportion of Participants In Sustained Remission (Total Mayo score) | Week 16 To Weeks 52 and 104 |
| Proportion of Participants In Sustained Remission (Total Mayo score) | Week 8 To Weeks 16, 52 and 104 |
| 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 |
| 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 |
| 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 |
| 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) | Baseline, weeks 8, 16, 52, and 104 |
| 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 |
| Portion of participants with dose change of tofacitinib | Week 8, 16, 52 and 104 |
| Portion of participants with a termination of tofacitinib | Week 8, 16, 52 and 104 |
| Portion of participants with dose and dose changes of tofacitinib and corticosteroids | Week 8, 16, 52 and 104 |
| 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 |
| Proportion of participants with changes in EQ5D and SHS | Baseline, Week 2 |
| Proportion of particpants with rectal bleeding and stool frequency sub score indicative of mild disease | Baseline, Week 2 |
| Proportion of participants with stool frequency and rectal bleeding subscore of 0 | Baseline, Week 2 |
| Proportion of participants with mild abdominal pain | Baseline, week 2, 8, 16, 52 and 104 |
| Proportion of participants with no abdominal pain | Baseline, week 2, 8, 16, 52 and 104 |
| Proportion of participants with no bowel urgency | Baseline, Weeks 2, 8, 16, 52 and 104. |
| Proportion of participants with reduction of ≥ 1 point from baseline rectal bleeding and stool frequency sub score | Baseline, Week 2 |
| Proportion of patients achieving symptomatic remission | Symptomatic remission is defined as a total sum of 0 of the to Mayo sub-scores stool frequency(SF) and rectal bleeding (RB) | Baseline, weeks 2, 8, 16, 52 and 104. |
| Proportion of patients achieving symptomatic remission stratified on steroid use at baseline or not. | Baseline, weeks 2, 8, 16, 52 and 104 |
| Proportion of patients achieving symptomatic response | Symptomatic response is defined as a decrease of at least 50% of the sum of the Mayo-sub-scores stool frequency (SF) and rectal bleeding (RB). | Baseline, weeks 2, 8, 16, 52 and 104 |
| Proportion of patients achieving symptomatic response stratified on steroid use at baseline | Baseline, weeks 2, 8, 16, 52 and 104 |
| Proportion of patients in steroid-free clinical remission (pMayo and full Mayo score)stratified based on steroid use at baseline or not. | 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) | Baseline, weeks 8, 16, 52 and 104 |
| Change from baseline in bowel urgency (as measured by SCCAI) | SCCAI is the Simple Clinical Colitis Activity Index bowel urgency sub-score used to assess the bowel urgency. | Weeks 2, 8, 16, 52 and 104 |
| Borås |
| Sweden |
| Gävle Hospital | Gävle | 80324 | Sweden |
| SU/Sahlgrenska, Gastroenterologi & Hepatologi | Gothenburg | Göteborg | Sweden |
| Medicinkliniken, Länssjukhuset Ryhov, Sjukhusgatan | Jönköping | 55185 | Sweden |
| Daniel Molin | Kristianstad | 29185 | Sweden |
| Shiprock Consulting AB, | Lidingö | Sweden |
| Mag-Tarmmedicinska kliniken, Universitetssjukhuset i Linköping | Linköping | 58185 | Sweden |
| Region skåne, Skånes Universitetssjukhus | Malmö | 20501 | Sweden |
| Medicinmottagning 4, Medicinska Kliniken, Universitetssjukhuset Örebro | Örebro | 70185 | Sweden |
| Stockholm Gastro Center | Stockholm | 11486 | Sweden |
| Ersta Sjukhus, Medicinkliniken, Fjällgatan 44 | Stockholm | 11691 | Sweden |
| Karolinska Universitetssjukhuset i Solna, Eugeniavägen 3, B4-09, | Stockholm | 17176 | Sweden |
| Danderyds Hospital | Stockholm | 18257 | Sweden |
| Medicinkliniken, Umeås Universitetssjukhus | Umeå | 50985 | Sweden |
| Specialmedicin, Akademiska Sjukhuset, Sjukhusvägen ing 40 | Uppsala | 75185 | Sweden |
| Medicinmottagningen gastroenterologi, Västmanlands sjukhus | Västerås | 72189 | Sweden |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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