A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
- Conditions
- rheumatismRheumatoid Arthritis10023213
- Registration Number
- NL-OMON45740
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
For a complete list of study inclusion criteria, please refer to Section 4.2 of the study protocol.;Main Eligibility Criteria
1) Male or female subjects who are *18 years of age, on the day of signing informed consent.
2) Have a diagnosis of RA (2010 ACR/EULAR criteria) , and are ACR functional class I-III.
3) Have *6 swollen joints (from a SJC66) and *6 tender joints (from a TJC68) at both Screening and Day 1.
4) Must meet at least one of the following parameters at Screening:
a) *1 documented joint erosion on radiographs of the hands, wrists or feet by central reading AND a positive result for anti-CCP or RF at the central laboratory,
OR b) *3 documented erosions on radiographs of the hands, wrists or feet by central reading if both antibodies (ie, RF, anti-CCP) are negative (based on central laboratory),
OR c) Serum CRP * 6 mg/L based on central laboratory value
5) Ongoing treatment with a stable dose of MTX as described below:
a) Use of oral MTX on a continuous basis for at least 12 weeks prior to Day 1 and on a stably prescribed dose of 7.5-25 mg/weekly for at least 4 weeks prior to Day 1. Stable doses of <7.5 mg/week are allowed only in the presence of intolerance or toxicity to higher doses or where higher doses are prohibited by the local label or local clinical practice. Doses >25 mg weekly are not permitted during the study.
b) Subjects should be receiving an adequate and prescribed stable dose of folic acid (*5 mg/week total dose or as per local clinical practice) which should be confirmed or initiated at Screening,
and continued throughout the study.
c) Subjects may use concomitant hydroxychloroquine (HCQ) *400 mg/day or chloroquine *250 mg/day during the study with the prescription having been stable for at least 4 weeks prior to Day 1.
For a complete list of study exclusion criteria, please refer to section 4.3 of the study protocol:
Subjects that have failed prior therapy with a bDMARD are not eligible to participate. Subjects with prior exposure to one bDMARD may be enrolled (approximately 20% of total study population) if there is documented evidence of limited exposure (ie, less than 3 months) to the bDMARD
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety:<br /><br>Safety will be assessed by documentation of AEs, clinical laboratory tests,<br /><br>physical examinations, vital signs, and 12-lead ECGs during the study.<br /><br><br /><br>Efficacy:<br /><br>The primary endpoint is the proportion of subjects who achieve an ACR20<br /><br>response at Week 12.<br /><br><br /><br>Pharmacokinetics:<br /><br>Plasma concentrations of filgotinib and its metabolite (GS-829845) will be<br /><br>analyzed.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy:<br /><br>The key secondary endpoints are:<br /><br>* The proportion of subjects who achieve DAS28 (CRP)*3.2 at Week 12<br /><br>* Change from Baseline in the HAQ-DI score at Week 12<br /><br>* The proportion of subjects who achieve DAS28 (CRP)<2.6 at Week 24<br /><br>* Change from Baseline in mTSS at Week 24</p><br>