Colitis, Ulcerative
Conditions
Keywords
golimumab, ulcerative colitis, steroid-dependent
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.
Interventions
DRUGGolimumab
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
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical and endoscopic steroid-free remission | week 16 | Total Mayo score ≤2, with no sub-score \>1. No concomitant corticosteroid therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients in clinical and endoscopic remission | week 52 | Total Mayo score ≤2, with no sub-score \>1 |
| percentage of patients in clinical remission | week 52 | partial Mayo score ≤2, with no sub-score \>1 |
| percentage of patients with mucosal healing | week 16 and 52 | complete mucosal healing: endoscopic sub-score 0 |
| clinical response | week 16 | Decrease in total Mayo score of at least 2 point and 30 % |
| quality of life | week 16 and 52 | IBDQ questionnaire |
| percentage of infliximab responders | week 52 | — |
| identification of patients that would benefit from golimumab therapy | through week 52 | evaluation of baseline characteristics of patients to identify potential response-predictive factors. |
| percentage of patients with histological healing | week 16 and 52 | histological healing: Geboes score \<3 and no Mayo sub-score \>1 |
Countries
Italy
Contacts
Primary ContactSilvio Danese, MD, PhD
Backup ContactGionata Fiorino, MD, PhD
Outcome results
None listed