Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis (SCILLA)
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|ClinicalTrials.gov Identifier: NCT03151525|
Recruitment Status : Unknown
Verified May 2017 by Istituto Clinico Humanitas.
Recruitment status was: Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine (AZA).
Each patient will be followed for 12 months.
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative||Drug: Azathioprine Drug: Infliximab||Phase 4|
All eligible subjects will be able to participate in the study at any infusion occurred after 12 months since the beginning. They will be screened by medical history, physical examination, blood and faecal tests (included C-reactive protein and faecal calprotectin), as required by clinical practice. No children, pregnant or breastfeeding women, or elder subjects will be included. A colonoscopy + biopsies in the area of greater inflammation will be performed within ± 3 weeks since the baseline visit. The subjects can then be randomized and receive their first dose of study medication.
Subjects will be then evaluated every 8 weeks for the following 12 months from the randomization. Clinical and blood tests will be performed, and the partial Mayo Score will be calculated at each visit, until the final visit, when a new colonoscopy with biopsies will be repeated and the global Mayo Score will be evaluated. At final visit a new faecal sample for calprotectin will be collected.
Safety of the study treatments will be evaluated at each study visit. In case of study agent discontinuation, the patient will be managed according to usual practice and followed for the entire study period. Patients randomized in AZA arm, could restart IFX.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized parallel two-arm prospective open-label study|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab|
|Actual Study Start Date :||May 8, 2017|
|Estimated Primary Completion Date :||October 3, 2019|
|Estimated Study Completion Date :||April 3, 2020|
Azathioprine 2-2.5 mg/kg/day, according to approved indication
AZA treatment after IFX withdrawal for maintenance of remission
Active Comparator: Infliximab
Infliximab 5 mg/kg every 8 weeks
IFX treatment for maintenance of remission
- Relapse rate [ Time Frame: 12 months ]relapse rate in the two study groups.
- Relapse time [ Time Frame: 12 months ]Mean time to relapse in the two groups
- Number of adverse events [Safety and Tolerability] [ Time Frame: 12 months ]Number of adverse events of the two study strategies
- Number of serious adverse events [Safety and Tolerability] [ Time Frame: 12 months ]Number of serious adverse events of the two study strategies
- Identification of potential risk factors for relapse. Age, sex, smoking habits, histological healing of mucosa and each Mayo subscore at baseline will be examined [ Time Frame: 12 months ]Potential risk factor for relapse will be evaluated by univariable analysis, and a multivariable analysis will be performed for all factors with p<0.30. Risk factors will be also analysed by logistic regression. Analysis of predetermined baseline characteristics (age, sex, smoking habits, histological healing of mucosa at baseline, and each Mayo subscore (stool number, presence of blood, colonic ulcerations) excluding the physician global assessment) to identify predictive factors for relapse.
- Direct costs [Pharmacokinetics] [ Time Frame: 12 months ]Direct costs of the two treatment strategies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151525
|Contact: Silvio Danese, MD, PhD||+390282245555||IBDclinicaltrials@humanitas.it|
|Contact: Gionata Fiorino, MD, PhDfirstname.lastname@example.org|