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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golimumab | Experimental | Subcutaneous golimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab | Drug | Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2) Maintenance regimen:
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvio Danese, MD, PhD | Contact | 0039028224 | 5555 | sdanese@hotmail.com |
| Gionata Fiorino, MD, PhD | Contact | 0038028224 | 5555 | gionata.fiorino@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Silvio Danese, MD, PhD | IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IBD Center | Recruiting | Rozzano | MI | 20089 | Italy |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C529000 | golimumab |
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|
| 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 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |