A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease
- Conditions
- Moderately to Severely Active Crohn's Disease (CD)MedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-002763-34-SK
- Lead Sponsor
- Galapagos NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
• Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial
Criterion modified per amendment 9
2.1) Must have enrolled in a CD parent protocol, GS-US-419-4015, GS- US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos- sponsored filgotinib treatment study for CD
• Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
Criterion modified per amendment 9
4.1) Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
• 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
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 920
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
• Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for the present study.
• 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 or Sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
Criterion modified per amendment 9
4.1) Females who may wish to become pregnant and/or plan
to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and for at least 30 days after the last dose of study drug
• Criterion modified per amendment 9
6.1) Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined
in the protocol
• Use of prohibited concomitant medications as outlined in the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-Sponsored filgotinib treatment study in CD;Secondary Objective: To evaluate the effect of filgotinib on Patient Reported Outcomes (PRO2) and Crohn’s Disease Activity Index (CDAI) scores;Primary end point(s): Safety, evaluated through AEs, clinical laboratory tests, and vital signs;Timepoint(s) of evaluation of this end point: When filgotinib becomes<br>commercially available in the country or until the end of study (31<br>January 2025), whichever comes first.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline in PRO2 and CDAI scores;Timepoint(s) of evaluation of this end point: When filgotinib becomes<br>commercially available in the country or until the end of study (31<br>January 2025), whichever comes first.