Clinical Trial: Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis

Brief Summary:

This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14.

At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.

Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.


Detailed Summary:
Sponsor: Istituto Clinico Humanitas

Current Primary Outcome: clinical and endoscopic steroid-free remission [ Time Frame: week 16 ]

Total Mayo score ≤2, with no sub-score >1. No concomitant corticosteroid therapy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • clinical response [ Time Frame: week 16 ]
    Decrease in total Mayo score of at least 2 point and 30 %
  • percentage of patients in clinical and endoscopic remission [ Time Frame: week 52 ]
    Total Mayo score ≤2, with no sub-score >1
  • percentage of patients in clinical remission [ Time Frame: week 52 ]
    partial Mayo score ≤2, with no sub-score >1
  • percentage of patients with mucosal healing [ Time Frame: week 16 and 52 ]
    complete mucosal healing: endoscopic sub-score 0
  • percentage of patients with histological healing [ Time Frame: week 16 and 52 ]
    histological healing: Geboes score <3 and no Mayo sub-score >1
  • quality of life [ Time Frame: week 16 and 52 ]
    IBDQ questionnaire
  • percentage of infliximab responders [ Time Frame: week 52 ]
  • identification of patients that would benefit from golimumab therapy [ Time Frame: through week 52 ]
    evaluation of baseline characteristics of patients to identify potential response-predictive factors.


Original Secondary Outcome: Same as current

Information By: Istituto Clinico Humanitas

Dates:
Date Received: March 26, 2015
Date Started: March 2015
Date Completion: January 2017
Last Updated: April 7, 2015
Last Verified: April 2015