A Phase 4 interventional study of Golimumab in Colitis, Ulcerative, sponsored by Istituto Clinico Humanitas. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-08.
Sponsored by Istituto Clinico Humanitas · Phase 4, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subcutaneous golimumab
Drug: Golimumab
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
Also known as: Simponi
clinical and endoscopic steroid-free remission
Total Mayo score ≤2, with no sub-score \>1. No concomitant corticosteroid therapy.
Time frame: week 16
clinical response
Decrease in total Mayo score of at least 2 point and 30 %
Time frame: week 16
percentage of patients in clinical and endoscopic remission
Total Mayo score ≤2, with no sub-score \>1
Time frame: week 52
percentage of patients in clinical remission
partial Mayo score ≤2, with no sub-score \>1
Time frame: week 52
percentage of patients with mucosal healing
complete mucosal healing: endoscopic sub-score 0
Time frame: week 16 and 52
percentage of patients with histological healing
histological healing: Geboes score \<3 and no Mayo sub-score \>1
Time frame: week 16 and 52
quality of life
IBDQ questionnaire
Time frame: week 16 and 52
percentage of infliximab responders
Time frame: week 52
identification of patients that would benefit from golimumab therapy
evaluation of baseline characteristics of patients to identify potential response-predictive factors.
Time frame: through week 52
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Istituto Clinico Humanitas