Colitis, Ulcerative Clinical Trial
— SCILLAOfficial title:
Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | April 3, 2020 |
Est. primary completion date | October 3, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age 18 -65 years - Written informed consent and willing to adhere to study procedures. - Therapy with infliximab since at least 12 months, with one infusion every 8 weeks (a maximum interval between two infusions of ± 3 weeks is allowed) - Sustained steroid-free remission in the last 6 months prior to inclusion, except for use of steroids as a preventive measure for infliximab infusion reaction, if required by local guidelines. - Global Mayo score at baseline = 2 - All Mayo subscores = 1 - Absence of rectal bleeding - Effective methods to avoid pregnancy during the study period Exclusion Criteria: - Disabling and persisting extraintestinal manifestation at baseline - Patients unable to comply with study procedures - Known intolerance or previous allergic reaction to thiopurines - Concomitant therapy with allopurinol - Any disease not compatible with the use of infliximab or azathioprine, as per clinician's judgement. - Need for dose escalation of infliximab in the last 12 months prior to baseline. - White blood cell count < 3000/mmc or absolute clinically relevant lymphopenia at baseline - Active pregnancy or breastfeeding; willing for pregnancy during the study period |
Country | Name | City | State |
---|---|---|---|
Italy | IBD Center | Rozzano | MI |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas | Agenzia Italiana del Farmaco |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Direct costs [Pharmacokinetics] | Direct costs of the two treatment strategies | 12 months | |
Primary | Relapse rate | relapse rate in the two study groups. | 12 months | |
Secondary | Relapse time | Mean time to relapse in the two groups | 12 months | |
Secondary | Number of adverse events [Safety and Tolerability] | Number of adverse events of the two study strategies | 12 months | |
Secondary | Number of serious adverse events [Safety and Tolerability] | Number of serious adverse events of the two study strategies | 12 months | |
Secondary | Identification of potential risk factors for relapse. Age, sex, smoking habits, histological healing of mucosa and each Mayo subscore at baseline will be examined | 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. | 12 months |
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