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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03151525
Date of registration: 08/05/2017
Prospective Registration: Yes
Primary sponsor: Istituto Clinico Humanitas
Public title: Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis SCILLA
Scientific title: Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab
Date of first enrolment: May 8, 2017
Target sample size: 100
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03151525
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Italy
Contacts
Name:     Silvio Danese, MD, PhD
Address: 
Telephone: 0039028224
Email: IBDclinicaltrials@humanitas.it
Affiliation: 
Name:     Silvio Danese, MD, PhD
Address: 
Telephone: +390282245555
Email: IBDclinicaltrials@humanitas.it
Affiliation: 
Key inclusion & exclusion 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 (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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Colitis, Ulcerative
Intervention(s)
Drug: Azathioprine
Drug: Infliximab
Primary Outcome(s)
Relapse rate [Time Frame: 12 months]
Secondary Outcome(s)
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]
Number of adverse events [Safety and Tolerability] [Time Frame: 12 months]
Number of serious adverse events [Safety and Tolerability] [Time Frame: 12 months]
Relapse time [Time Frame: 12 months]
Secondary ID(s)
1685
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Agenzia Italiana del Farmaco
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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