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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: Golimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Golimumab<br>Subcutaneous golimumab | Drug: Golimumab<br>* Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2) Maintenance regimen: body weight < 80kg: 50 mg every 4 weeks body weight ≥ 80 kg: 100 mg every 4 weeks<br>* Other names: Simponi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and endoscopic steroid-free remission | Total Mayo score ≤2, with no sub-score >1. No concomitant corticosteroid therapy. | week 16 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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golimumab, ulcerative colitis, steroid-dependent