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

Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002579-27-IT

Enrollment

100

Registered

2015-01-19

Start date

2015-03-03

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

active steroid-dependent ulcerative colitis MedDRA version: 17.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Trade Name: SIMPONI Product Name: SIMPONI Product Code: NA Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Secondary end point(s): xxx;Timepoint(s) of evaluation of this end point: week 16 and week 52	—

Countries

Italy

Contacts

Public ContactCentro per la Ricerca e la Cura del

Istituto Clinico Humanitas

IBDclinicaltrials@humanitas.it+3902822245556

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026