Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis

• Status: Unknown status
• Trial end date: 2020-04-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Clinico Humanitas
• Collaborator: Agenzia Italiana del Farmaco
• Treatments: Azathioprine; Infliximab

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