A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 950 人开始时间: 2016年10月31日最近更新: 2019年6月30日

研究概览

暂无简介。

•1. Subject has not responded at the end of the induction period (Week 8) in Study M14-234 (Substudy 1), who has been an inadequate responder during the maintenance period of Study M14-234 (Substudy 3), or who has responded and successfully completed Study M14-234 substudy 3.
•2. Women of childbearing potential (refer to Section 5.2.4) must have a negative urine pregnancy test at Week 0 visit.
•3. If female, subject must meet the criteria as stated in Section 5.2.4 of this protocol: Contraception Recommendations and Pregnancy Testing.
•4. Subject is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234).
•5. Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 800
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•1. For any reason subject is considered by the investigator to be an unsuitable candidate.
•2. Female subject with a positive pregnancy test at Baseline (final visit of Study M14-234) or who is considering becoming pregnant during the study.
•3. Subject with an active or recurrent infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
•4. Current evidence of active or untreated latent tuberculosis.
•5. Subject with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure (New
•York Heart Association class III or IV), recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.

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