Chronic antibiotic refractory and relapsing pouchitis
Conditions
Interventions
Trade Name: ustekinumab (Stelara)
Product Name: Stelara
Pharmaceutical Form: Injection
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The subject is male or female and aged 18 to 80 years inclusive • The subject has a history of ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC) • The subject has pouchitis that is (a) relapsing or (b) chronic antibiotic refractory, defined by an mPDAI score =5 assessed as the average from 3 days immediately prior to the baseline endoscopy visit and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either (a) =3 recurrent episodes within the last year, each treated with =2 weeks of antibiotic or other prescription therapy, or (b) requiring maintenance antibiotic therapy taken continuously for =4 weeks immediately prior to the baseline endoscopy visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Crohn’s disease (CD), CD-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (IPS), isolated or predominant cuffitis, infectiouw pouchitis, diverting ostomy or mechanical complications of the pouch • Previous treatment with an anti-IL12/23 or an anti-IL23 antibody • Any investigational or approved biologic agent within 30 days of baseline • Nonbiologic investigational therapy or tofacitinib within 30 days prior to baseline • Active or untreated latent tuberculosis (TB) • Chronic hepatitis B virus (HBV) infection, chronic hepatitis C virus (HCV) infection, a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at screening) or subject is immunodeficient • Active severe infection (e.g. sepsis, cytomegalovirus, listeriosis or C. difficile) • History of malignancy or current malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Percentage of subjects achieving clinically relevant steroid-free remission;Secondary Objective: •Percentage of subjects achieving partial response •Time to clinically relevant steroid-free remission •Change in mPDAI endoscopic subscore •Change in mPDAI symptomatic subscore •Change in total mPDAI score •Change in European Quality of Life 5 Dimensions (EQ-5D) ;Primary end point(s): The percentage of subjects achieving clinically relevant steroid-free remission (mPDAI score <5 and a reduction by =2 points from baseline) after 16 weeks of treatment;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The percentage of subjects achieving clinically relevant steroid-free remission (mPDAI score <5 and a reduction by =2 points from baseline) after 48 weeks of treatment • The percentage of subjects achieving partial response (reduction of mPDAI score by =2 points from baseline) after 16 weeks of treatment • The percentage of subjects achieving partial response (reduction of mPDAI score by =2 points from baseline) after 48 weeks of treatment • Time to clinically relevant remission • Change in mPDAI endoscopic subscore at Week 16 and 48 compared to baseline • Change in mPDAI symptomatic subscore at Week 16 and 48 compared to baseline • Change in total mPDAI score at Week 16 and 48 compared to baseline • Change in European Quality of Life 5 Dimensions (EQ-5D) at Week 16, 32 and 48 compared to baseline ;Timepoint(s) of evaluation of this end point: See above | — |
Countries
Belgium
Contacts
Public ContactClinical trial assistant
UZ Leuven
Outcome results
None listed