NCT04338204已完成不适用
OBSERVATIONAL STUDY OF TOFACITINIB IN ULCERATIVE COLITIS IN SWEDEN (ODEN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 102
- 试验地点
- 32
- 主要终点
- Proportion of Participants in Remission as Measured by Partial Mayo Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: tofacitinib (Drug)
结局指标
主要结局
Proportion of Participants in Remission as Measured by Partial Mayo Score
时间窗: Week 52
Clinical Remission is defined as a partial score of \<2 points with 0 points regarding rectal bleeding.
次要结局
- Proportion of participants with no bowel urgency(Baseline, Weeks 2, 8, 16, 52 and 104.)
- Proportion of Participants who are taking tofacitinib(Baseline, Weeks 8, 16, 52, 104)
- Proportion of Participants in Clinical Remission Based on Total Mayo Score(Weeks 8, 16, 52, and 104)
- Proportion of Participants in Clinical Response Based on Total Mayo Score(Weeks 8, 16, 52, and 104)
- Proportion of Participants in Clinical Remission Based on Partial Mayo Score(Weeks 8, 16, 52 and 104)
- Proportion of Participants in Clinical Response Based on Partial Mayo Score(Weeks 8, 16, 52 and 104)
- Change From Baseline In Partial Mayo Score(Baseline, Weeks 8, 16, 52 and 104)
- Change from Baseline of C-Reactive Protein (CRP)(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 Level of Fecal Calprotectin (f-calprotectin)(Baseline, Weeks 8, 16, 52 and 104)
- Proportion of Participants in Endoscopic Remission, Mucosal Healing or Endoscopic Response(Week 8, 16, 52 and 104)
- Proportion of Responders defined by a Fecal Calprotectin (f-calprotectin) Reduction of ≥50%, ≥75% or ≥90%(Weeks 8, 16, 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 Who Had a Colectomy(Weeks 8, 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 Endoscopic Remission, Mucosal Healing or Endoscopic Response(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(Week 16 to 52 and 104)
- Change From Baseline In Inflammatory Bowel Disease Fatigue (IBD-F) Score(Baseline, Weeks 8, 16, 52 and 104)
- Portion of participants with dose change of tofacitinib(Week 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)
- Portion of participants with dose and dose changes of tofacitinib and corticosteroids(Week 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 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(Week 16 to 52 and 104)
- Portion of participants with a termination of tofacitinib(Week 8, 16, 52 and 104)
- 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 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 reaching f-calprotectin below 250 mg/kg of those that had f-calprotectin above 250 mg/kg at baseline(Baseline, week 8, 16, 52 and 104)
- Proportion of particpants with changes in rectal bleeding and stool frequency(Baseline, Week 2)
- Proportion of participants with changes in EQ5D and SHS(Baseline, Week 2)
- Proportion of patients achieving symptomatic remission(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 participants with reduction of ≥ 1 point from baseline rectal bleeding and stool frequency sub score(Baseline, Week 2)
- 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(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.(Baseline, weeks 8, 16, 52 and 104)
- Change from baseline in bowel urgency (as measured by SCCAI)(Weeks 2, 8, 16, 52 and 104)
- Proportion of Participants in Steroid-Free Clinical Remission(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 (Total Mayo score)(Week 16 To Weeks 52 and 104)
- Proportion of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response(Week 8 to Week 16, 52 and 104)
研究者
研究点 (32)
Loading locations...
相似试验
已完成
不适用
Tofacitinib in Adult Patients With Moderate to Severe Ulcerative ColitisUlcerative ColitisNCT04424303Pfizer152
终止
不适用
Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center StudyUlcerative ColitisNCT03772145University of North Carolina, Chapel Hill103
Enrolling By Invitation
4 期
Efficacy and Safety of Tofacitinib in Refractory Blau SyndromeBlau SyndromeNCT06660329Peking Union Medical College Hospital30
终止
不适用
Tofacitinib Registry of Patients With Ulcerative Colitis in GermanyColitis, UlcerativeBiologicsTofacitiniibChronic Inflammatory Small Bowel DiseaseBowel Diseases, InflammatoryBowel DiseaseCEDNCT04032756Ced Service GmbH50
进行中（未招募）
2 期
Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis ManagementUlcerative Colitis AcuteNCT04925973McMaster University24