MedTrace Logo

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

NCT03151525 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-05-12

No results posted yet for this study

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.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Azathioprine

AZA treatment after IFX withdrawal for maintenance of remission

DRUG

Infliximab

IFX treatment for maintenance of remission

Sponsors & Collaborators

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2019-10-03
Completion
2020-04-03

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03151525 on ClinicalTrials.gov