EUCTR2016-002707-25-IT
Active, not recruiting
Phase 1
Comparison between two therapeutic strategies for the maintenance of clinical and endoscopic remission in patients with ulcerative colitis treated by infliximab (SCILLA). - n.a.
IRCCS ISTITUTO CLINICO HUMANITAS0 sites100 target enrollmentJanuary 13, 2021
Conditionspatients with ulcerative colitisMedDRA version: 20.0Level: LLTClassification code 10045282Term: UCSystem Organ Class: 100000004856MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- patients with ulcerative colitis
- Sponsor
- IRCCS ISTITUTO CLINICO HUMANITAS
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 (, according to the summary of product characteristics)
- •\- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
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.
Outcomes
Primary Outcomes
Not specified
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