NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Ulcerative Colitis
Date of first enrollment	10/04/2009
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : golimumab INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : SC

Outcome(s)

Primary Outcome	Efficacy,Safety
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Have a biopsy consistent with the diagnosis of moderately to severely active ulcerative colitis (UC) prior to the beginning of the trial Must either be currently receiving treatment with, or have a history of having failed to respond to, or tolerate, at least 1 of the following therapies: oral 5-ASAs, oral corticosteroids, 6-mercaptopurine(6MP) and azathioprine (AZA ) Have or have had a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC)
Exclude criteria	Have severe extensive ulcerative colitis that is likely to require a colectomy within 12 weeks of study entry Have UC limited to the rectum only or to < 20 cm of the colon Presence of a stoma Presence or history of a fistula Previous exposure to anti-TNF therapies