Filgotinib in Long-Term Extension Study of Adults With Crohns Disease
- Conditions
- Health Condition 1: null- Crohn’s Disease
- Registration Number
- CTRI/2017/08/009477
- Lead Sponsor
- Gilead Sciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
• Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
• Must have met all eligibility criteria from a Gilead-sponsored CD parent protocol
• Females of childbearing potential must have a negative pregnancy test at Day 1
• Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method of contraception as described in the study protocol, for the duration described
• Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
• Must have completed all required procedures or met protocol specified
efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib
treatment study for CD
• Known hypersensitivity to the study drug
• Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol
• Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the study protocol
• Use of prohibited medications as outlined in the study protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and <br/ ><br>Abnormal Clinical Laboratory TestsTimepoint: Up to 432 weeks
- Secondary Outcome Measures
Name Time Method Change from Baseline in Crohns Disease Activity Index (CDAI) ScoresTimepoint: Baseline and up to 432 weeks;Change from Baseline in PRO2 Scores <br/ ><br>PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency.Timepoint: Baseline and up to 432 weeks