Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
NCT ID: NCT02885181
Last Updated: 2018-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2016-09-21
2017-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GS-9876 - 30 mg
GS-9876 30 mg + filgotinib placebo for 12 weeks
GS-9876
One tablet administered orally once daily
Filgotinib placebo
Two tablets administered orally once daily
Methotrexate
Background therapy with methotrexate administered orally or parenterally once weekly
GS-9876 - 10 mg
GS-9876 10 mg + filgotinib placebo for 12 weeks
GS-9876
One tablet administered orally once daily
Filgotinib placebo
Two tablets administered orally once daily
Methotrexate
Background therapy with methotrexate administered orally or parenterally once weekly
Filgotinib
Filgotinib + GS-9876 placebo for 12 weeks
Filgotinib
Two tablets administered orally once daily
GS-9876 placebo
One tablet administered orally once daily
Methotrexate
Background therapy with methotrexate administered orally or parenterally once weekly
Placebo
GS-9876 placebo + filgotinib placebo for 12 weeks
GS-9876 placebo
One tablet administered orally once daily
Filgotinib placebo
Two tablets administered orally once daily
Methotrexate
Background therapy with methotrexate administered orally or parenterally once weekly
Interventions
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GS-9876
One tablet administered orally once daily
Filgotinib
Two tablets administered orally once daily
GS-9876 placebo
One tablet administered orally once daily
Filgotinib placebo
Two tablets administered orally once daily
Methotrexate
Background therapy with methotrexate administered orally or parenterally once weekly
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Omega Research Consultants
DeBary, Florida, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Medical Associates of North Georgia
Canton, Georgia, United States
Center For Arthritis and Osteoporosis
Elizabethtown, Kentucky, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Accurate Clinical Management - Najam
Houston, Texas, United States
Accurate Clinical Research Inc.
Stafford, Texas, United States
Medical Center Research LLC
Webster, Texas, United States
MHAT-Plovdiv AD
Plovdiv, , Bulgaria
Umhat Kaspela
Plovdiv, , Bulgaria
NMTH Tsar Boris III
Sofia, , Bulgaria
A-Shine s.r.o.
Pilsen, , Czechia
Medical Plus, S.R.O.
Uherské Hradiště, , Czechia
LLC Arensia Exploratory Medicine
T'bilisi, , Georgia
ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital
Chisinau, , Moldova
ClinicMed Badurski i wspolnicy Spolka Jawna
Bialystok, , Poland
Kharkiv City Hospital 8
Kharkiv, , Ukraine
Medical Center_Clinic of International Institute of clinical Studies
Kyiv, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001496-75
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-379-1582
Identifier Type: -
Identifier Source: org_study_id
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