Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisone

Phase 1

Conditions: active steroid-dependent ulcerative colitis
MedDRA version: 17.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2014-002579-27-IT

Lead Sponsor: Istituto Clinico Humanitas

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

a. Patients aged between 18 and 65 at the moment of the inclusion
b. Ability to understand the procedures of the study and sign the informed consent form
c. Confirmed diagnosis of ulcerative colitis for at least 6 months.
d. Naïve to therapy with monoclonal antibodies (both conventional and experimental)
and.
e. Mayo Score global = 6 at baseline
f. Steroid-dependence

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a) Diagnosis of Crohn's disease or indeterminate colitis (IBD-U).
b) Active infection at baseline or a previous infection that has not healed at baseline.
c) History of solid tumors or blood cancers within 5 years of the inclusion.
d) Suspected latent tuberculosis infection.
e) Any other condition deemed risky for the patient during the study.
f) Pregnancy or lactation at baseline, or planned pregnancy screening up to 3 months after the end of the study.
g) Concomitant medications at baseline that should be continued during the study and are included in the list of treatments not allowed

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy evaluation of golimumab in inducing clinical and endoscopic remission at week 16 steroid-free;Secondary Objective: 1 Efficacy of golimumab in inducing and maintaining clinical response at week 16; <br>2 Efficacy of golimumab in maintaining clinical remission at week 52;<br>3 Efficacy of golimumab in maintaining the clinical and endoscopic remission at week 52; <br>4 Efficacy of golimumab in inducing and maintaining mucosal healing at week 16 and week 52; <br>5 Efficacy of golimumab in inducing healing histological week 16 and week 52;<br>6 Impact of golimumab on the patients quality of life; <br>7 Efficacy of the switch, from golinumab to infliximab, for non-responders subjects at week 16;<br>8 To identify predictors of response to golimumab (including biomarkers of inflammation, sex, age, medical history, baseline and histological healing at week 16).<br>;Primary end point(s): xxx;Timepoint(s) of evaluation of this end point: 16 weeks

Secondary Outcome Measures