Clinical trial NCT02412085: Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colitis, Ulcerative
Keywords: golimumab
ulcerative colitis
steroid-dependent
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* patients aged 18-65 years
* ability to understand the study procedures and sign the informed consent
* ulcerative colitis diagnosed at least 6 months before
* no previous exposure to anti-TNFs
* Global Mayo score ≥ 6 (with endoscopic sub-score ≥2) at baseline
* steroid-dependent disease
* women of childbearing potential must accept effective contraception during study participation and for at leas 6 months after the end of study participation

Exclusion Criteria:

* Crohn's disease or undetermined colitis
* active infections or previous infections not completely resolved at baseline
* malignancies in the previous 5 years
* suspected latent tuberculosis infection
* every other potentially harmful clinical condition, in the opinion of the investigator
* patients with moderately to severe heart failure (NYHA class III/IV)
* hepatic or renal failure
* pregnant or lactating women or women planning a pregnancy between baseline and the 3 months after study completion
* not permitted concomitant medications

Primary outcomes:
measure: clinical and endoscopic steroid-free remission
timeFrame: week 16
Secondary outcomes:
measure: clinical response
timeFrame: week 16
measure: percentage of patients in clinical and endoscopic remission
timeFrame: week 52
measure: percentage of patients in clinical remission
timeFrame: week 52
measure: percentage of patients with mucosal healing
timeFrame: week 16 and 52
measure: percentage of patients with histological healing
timeFrame: week 16 and 52
measure: quality of life
timeFrame: week 16 and 52
measure: percentage of infliximab responders
timeFrame: week 52
measure: identification of patients that would benefit from golimumab therapy
timeFrame: through week 52
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IBD Center
state: MI
Study officials:
affiliation: IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY
name: Silvio Danese, MD, PhD
role: STUDY_CHAIR
References: