Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT02885181
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- Active RA disease as defined by: a tender joint count (TJC) of ≥ 6 (out of 68), a swollen joint count (SJC) of ≥ 6 (out of 66) at screening and Day 1
- Inadequate response to treatment with oral or parenteral methotrexate (MTX) 7.5 to 25 mg/week continuously for at least 12 weeks
- No evidence of active or latent tuberculosis
Key
- Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6 months prior to the first dose of study drug and documented return of CD19+ cells at screening
- Prior treatment with any commercially available or investigational spleen tyrosine kinase (SYK) inhibitor
- Concurrent treatment with any other conventional synthetic DMARD (csDMARD) other than MTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriate wash out as defined in the protocol)
- Concurrent treatment with any biological disease modifying anti-rheumatic drug (bDMARD)(prior bDMARD treatment allowed if appropriate wash out as defined in the protocol). Prior failure to treatment with bDMARDs is not an exclusion criterion.
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Filgotinib Filgotinib Filgotinib + GS-9876 placebo for 12 weeks Placebo Filgotinib placebo GS-9876 placebo + filgotinib placebo for 12 weeks GS-9876 - 30 mg GS-9876 GS-9876 30 mg + filgotinib placebo for 12 weeks GS-9876 - 30 mg Filgotinib placebo GS-9876 30 mg + filgotinib placebo for 12 weeks GS-9876 - 10 mg Filgotinib placebo GS-9876 10 mg + filgotinib placebo for 12 weeks GS-9876 - 10 mg GS-9876 GS-9876 10 mg + filgotinib placebo for 12 weeks Placebo GS-9876 placebo GS-9876 placebo + filgotinib placebo for 12 weeks Filgotinib GS-9876 placebo Filgotinib + GS-9876 placebo for 12 weeks GS-9876 - 30 mg Methotrexate GS-9876 30 mg + filgotinib placebo for 12 weeks GS-9876 - 10 mg Methotrexate GS-9876 10 mg + filgotinib placebo for 12 weeks Filgotinib Methotrexate Filgotinib + GS-9876 placebo for 12 weeks Placebo Methotrexate GS-9876 placebo + filgotinib placebo for 12 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12 Baseline; Week 12 Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved ACR50 Improvement at Week 12 Week 12 ACR50 response was defined as having ≥ 50% improvement from baseline in the number of tender and the number of swollen joints, and a 50% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP.
Percentage of Participants Who Achieved ACR70 Improvement at Week 12 Week 12 ACR70 response was defined as having ≥ 70% improvement from baseline in the number of tender and the number of swollen joints, and a 70% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP.
Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 Baseline; Week 12 The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported tool used to assess the ability to perform tasks in 8 functional categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional category were collected as 0 (without any difficulty) to 3 (unable to do a task in that area). The HAQ-DI score ranges from 0 (no disability) to 3 (completely disabled), when 6 or more categories are non-missing.
Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12 Week 12 American College of Rheumatology (ACR)20 response was defined as having ≥ 20% improvement from baseline in the number of tender and the number of swollen joints, and a 20% improvement in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity (PhGA), Participant's Global Assessment of Disease Activity (PtGA), Participant's pain assessment, Participant's assessment of physical function (HAQ-DI) score, and C-reactive protein (CRP).
Trial Locations
- Locations (19)
Center For Arthritis and Osteoporosis
🇺🇸Elizabethtown, Kentucky, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Albuquerque Center For Rheumatology
🇺🇸Albuquerque, New Mexico, United States
Medical Associates of North Georgia
🇺🇸Canton, Georgia, United States
Medical Center Research LLC
🇺🇸Webster, Texas, United States
Accurate Clinical Research Inc.
🇺🇸Stafford, Texas, United States
Medical Plus, S.R.O.
🇨🇿Uherske Hradiste, Czechia
A-Shine s.r.o.
🇨🇿Plzen, Czechia
Medical Center_Clinic of International Institute of clinical Studies
🇺🇦Kyiv, Ukraine
NMTH Tsar Boris III
🇧🇬Sofia, Bulgaria
LLC Arensia Exploratory Medicine
🇬🇪T'bilisi, Georgia
Omega Research Consultants
🇺🇸DeBary, Florida, United States
MHAT-Plovdiv AD
🇧🇬Plovdiv, Bulgaria
Umhat Kaspela
🇧🇬Plovdiv, Bulgaria
ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital
🇲🇩Chisinau, Moldova, Republic of
ClinicMed Badurski i wspolnicy Spolka Jawna
🇵🇱Bialystok, Poland
Kharkiv City Hospital 8
🇺🇦Kharkiv, Ukraine
Sarasota Arthritis Research Center
🇺🇸Sarasota, Florida, United States
Accurate Clinical Management - Najam
🇺🇸Houston, Texas, United States