To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.
This study is a Belgian prospective open label multicenter study to evaluate the efficacy and safety of ustekinumab in the treatment of relapsing or chronic antibiotic refractory pouchitis during a 48-week treatment period. Twenty subjects with a RPC and IPAA for UC who have developed relapsing or chronic antibiotic refractory pouchitis will be enrolled. All patients will receive intravenously (IV) ustekinumab \~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48. All subjects will receive concomitant antibiotic treatment with ciprofloxacin or metronidazole from baseline through Week 4. Intravenous induction doses will be 260mg for patients \<55kg, 390mg for patients between 55 and 85kg, and 520mg for patients with a body weight \>85 kg. Clinical and biochemical evaluation will be planned every 8 weeks. Efficacy will be assessed at Week 16 and Week 48 using mPDAI and PDAI scores, therefor a pouchoscopy with biopsy sampling will be performed. Patients who do not achieve partial response (reduction of mPDAI score by ≥2 points from baseline) at Week 16 will be discontinued.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
All patients will receive intravenously (IV) ustekinumab \~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48.
UZ Leuven
Leuven, Flanders, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
CHU de Liège, Sart Tilman
Liège, Belgium
The percentage of subjects achieving clinically relevant steroid-free remission
mPDAI score \<5 and a reduction by ≥2 points from baseline
Time frame: 16 weeks after baseline
The percentage of subjects achieving clinically relevant steroid-free remission
mPDAI score \<5 and a reduction by ≥2 points from baseline, without need for steroids
Time frame: 48 weeks after baseline
The percentage of subjects achieving partial response
reduction of mPDAI score by ≥2 points from baseline
Time frame: 16 weeks after baseline
The percentage of subjects achieving partial response
reduction of mPDAI score by ≥2 points from baseline
Time frame: 48 weeks after baseline
Time to clinically relevant remission
Time to mPDAI score \<5 and a reduction by ≥2 points from baseline
Time frame: Within 48 weeks after baseline
Change in mPDAI endoscopic subscore
Change in mPDAI endoscopic subscore from baseline
Time frame: At Week 16 and 48 compared to baseline
Change in mPDAI symptomatic subscore
Change in mPDAI symptomatic subscore from baseline
Time frame: At Week 16 and 48 compared to baseline
Change in total mPDAI score
Change in total mPDAI score from baseline
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Time frame: At Week 16 and 48 compared to baseline
Change in European Quality of Life 5 Dimensions (EQ-5D)
Change in European Quality of Life 5 Dimensions (EQ-5D) from baseline
Time frame: At Week 16, 32 and 48 compared to baseline