A comparative study on how well upadacitinib performs compared to oral prednisolone in treating and sustaining remission in moderate to severe ulcerative colitis
Not Applicable
Active, not recruiting
- Conditions
- Moderate-to-severe ulcerative colitisDigestive System
- Registration Number
- ISRCTN15078551
- Lead Sponsor
- Ministry of Health Kuwait
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1.Males + Females with moderate-to-severe UC
2.Age 18 – 60 years
3.All durations of disease
4.All extents of disease (proctitis / left-sided colitis / pancolitis)
5.Previously failed to respond to conventional therapies and/or anti-TNF therapy
6.Biologic-naïve
7.On a stable dose of 5-ASA or immunomodulator four weeks prior to the start of the study
Exclusion Criteria
1.Pregnant / lactating
2.Crohn’s colitis
3.Latent or active TB
4.Active infection
5.Current or past malignancy
6.Active or past thromboembolic disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes for the induction trial (week 1 – 8): <br>1. Clinical response or clinical remission at week 8:<br>1.1. Clinical response – defined as a decrease in the MMS by =2 points with an overall decrease of =30% from baseline, in addition to either a rectal bleeding (RB) subscore of 0 or 1 or a decrease in RB subscore by =1 point from baseline.<br>1.2. Clinical remission – defined as a modified Mayo stool-frequency (SF) subscore of 0 or a SF subscore of 1 with a decrease of =1 point from baseline, in addition to a RB subscore of 0 and an endoscopic subscore (ES) of 0 or 1. <br><br>Primary outcomes for the maintenance trial (week 9 – 48):<br>2. Clinical remission at week 40 (i.e. at 48 weeks overall)<br>2.1. Clinical remission – defined as a modified Mayo stool-frequency (SF) subscore of 0 or a SF subscore of 1 with a decrease of =1 point from baseline, in addition to a RB subscore of 0 and an endoscopic subscore (ES) of 0 or 1.
- Secondary Outcome Measures
Name Time Method 1. Inflammatory bowel disease questionnaire (IBD-Q) score to assess health-related quality of life: This will be assessed at baseline (week 0) then repeated at week 8 and 48 of the study. <br>2. C-Reactive Protein (CRP) (<10): A blood sample will be taken to monitor the CRP level at baseline (week 0), week 8 and 48 of the study.<br>3. Fecal calprotectin (<200): A fecal sample will be collected to monitor the fecal calprotectin level at baseline (week 0), week 8 and 48 of the study. <br>