Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission (UC-GOL)
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|ClinicalTrials.gov Identifier: NCT02412085|
Recruitment Status : Unknown
Verified April 2015 by Istituto Clinico Humanitas.
Recruitment status was: Recruiting
First Posted : April 8, 2015
Last Update Posted : April 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative||Drug: Golimumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||January 2017|
Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2)
Other Name: Simponi
- clinical and endoscopic steroid-free remission [ Time Frame: week 16 ]Total Mayo score ≤2, with no sub-score >1. No concomitant corticosteroid therapy.
- clinical response [ Time Frame: week 16 ]Decrease in total Mayo score of at least 2 point and 30 %
- percentage of patients in clinical and endoscopic remission [ Time Frame: week 52 ]Total Mayo score ≤2, with no sub-score >1
- percentage of patients in clinical remission [ Time Frame: week 52 ]partial Mayo score ≤2, with no sub-score >1
- percentage of patients with mucosal healing [ Time Frame: week 16 and 52 ]complete mucosal healing: endoscopic sub-score 0
- percentage of patients with histological healing [ Time Frame: week 16 and 52 ]histological healing: Geboes score <3 and no Mayo sub-score >1
- quality of life [ Time Frame: week 16 and 52 ]IBDQ questionnaire
- percentage of infliximab responders [ Time Frame: week 52 ]
- identification of patients that would benefit from golimumab therapy [ Time Frame: through week 52 ]evaluation of baseline characteristics of patients to identify potential response-predictive factors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412085
|Contact: Silvio Danese, MD, PhD||0039028224 ext firstname.lastname@example.org|
|Contact: Gionata Fiorino, MD, PhD||0038028224 ext email@example.com|
|Rozzano, MI, Italy, 20089|
|Contact: Silvio Danese, MD, PhD 0039028224 ext 5555 firstname.lastname@example.org|
|Study Chair:||Silvio Danese, MD, PhD||IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY|