A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alfasigma S.p.A.
- Enrollment
- 2,731
- Locations
- 684
- Primary Endpoint
- Proportion of Participants Experiencing Adverse Events (AEs)
Study Overview
Brief Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
This study was originally designed and initiated as a double-blind study but the study design will change to open-label following implementation of the protocol amendment # 4.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below:
- •Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug
- •Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder status
- •Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the long term extension (LTE)
- •Females of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods of contraception
Exclusion Criteria
- •Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
- •Known hypersensitivity to the study drug or its excipients
- •Any medical condition which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Arms & Interventions
Blinded Phase: Filgotinib 200 mg
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Intervention: Filgotinib (Drug)
Blinded Phase: Filgotinib 200 mg
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Intervention: Placebo to match filgotinib (Drug)
Blinded Phase: Filgotinib 100 mg
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Intervention: Filgotinib (Drug)
Blinded Phase: Filgotinib 100 mg
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Intervention: Placebo to match filgotinib (Drug)
Open Label Phase: Filgotinib 200 mg
Filgotinib 200 mg for up to 6 years
Intervention: Filgotinib (Drug)
Open Label Phase: Filgotinib 100 mg
Filgotinib 100 mg for up to 6 years
Intervention: Filgotinib (Drug)
Outcomes
Primary Outcomes
Proportion of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to 6 years
Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities
Time Frame: Up to 6 years
Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: Day 1 to Week 376 (end of study)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant after administration of an investigational product, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or significant medical event. A TEAE was any AE with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or premature discontinuation of study drug.
Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Serum Chemistry Parameters
Time Frame: Day 1 to Week 376 (end of study)
Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment. Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening). Blood samples were collected by venipuncture in the arm at the specified time points. The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.
Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Hematology Parameters
Time Frame: Day 1 to Week 376 (end of study)
Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment. Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) and Grade 4 (life-threatening). Blood samples were collected by venipuncture in the arm at the specified time points. The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time Frame: Baseline and At Week 312
SBP and DBP were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
Change From Baseline in Pulse Rate
Time Frame: Baseline and At Week 312
Pulse rate was collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
Change From Baseline in Respiration Rate
Time Frame: Baseline and At Week 312
Changes in respiration rates were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
Secondary Outcomes
- Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm(Up to 6 years)
- Percentage of Participants Who Achieved American College of Rheumatology (ACR) for 20, 50 and 70(At Week 312)