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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 April 2015 |
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Main ID: |
NCT02412085 |
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Date of registration:
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26/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission
UC-GOL |
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Scientific 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 |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02412085 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Silvio Danese, MD, PhD |
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Address:
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Telephone:
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0039028224 |
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Email:
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sdanese@hotmail.com |
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Affiliation:
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Name:
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Silvio Danese, MD, PhD |
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Address:
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Telephone:
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0039028224 |
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Email:
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sdanese@hotmail.com |
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Affiliation:
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Name:
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Silvio Danese, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colitis, Ulcerative
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Intervention(s)
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Drug: Golimumab
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Primary Outcome(s)
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clinical and endoscopic steroid-free remission
[Time Frame: week 16]
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Secondary Outcome(s)
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percentage of patients in clinical and endoscopic remission
[Time Frame: week 52]
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percentage of patients with mucosal healing
[Time Frame: week 16 and 52]
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percentage of infliximab responders
[Time Frame: week 52]
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percentage of patients in clinical remission
[Time Frame: week 52]
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clinical response
[Time Frame: week 16]
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percentage of patients with histological healing
[Time Frame: week 16 and 52]
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quality of life
[Time Frame: week 16 and 52]
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identification of patients that would benefit from golimumab therapy
[Time Frame: through week 52]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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