NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Ulcerative colitis
Date of first enrollment	24/08/2006
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : TA-650 (Infliximab) INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : Intravenous drip infusion

Outcome(s)

Primary Outcome	Efficacy (clinical response), Safety and Pharmacokinetics
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 16age old
Age maximum	Not applicable
Gender	Both
Include criteria	[Inclusion criteria] Patients with active ulcerative colitis, who have failed to response, have failed to successfully taper or have medical complications to other existing medications, 16 years and above, male and female. [Exclusion criteria] Patients who have received infliximab in the past, have a history of serious infection which caused hospitalization within 6 months before the registration, have an active tuberculosis, have a complication or a history of malignancy within 5 years before the registration.
Exclude criteria