A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITISâ??. - NA

Pfizer Limited0 个研究点目标入组 654 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
•2.Subjects who achieved clinical response in Study A3921094 or A3921095
•3.Women of childbearing potential must test negative for pregnancy prior to study enrollment
•4.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
•5.Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
•Note: There is no upper age limit mentioned in the protocol

•1. Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
•2. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns disease
•3. Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.

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