Clinical trial NCT02885181: Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-08-31
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12
timeFrame: Baseline; Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved ACR50 Improvement at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved ACR70 Improvement at Week 12
timeFrame: Week 12
measure: Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
timeFrame: Baseline; Week 12
Other outcomes:
Locations:
city: DeBary
country: United States
facility: Omega Research Consultants
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Research Center
state: Florida
city: Canton
country: United States
facility: Medical Associates of North Georgia
state: Georgia
city: Elizabethtown
country: United States
facility: Center For Arthritis and Osteoporosis
state: Kentucky
city: Albuquerque
country: United States
facility: Albuquerque Center For Rheumatology
state: New Mexico
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Houston
country: United States
facility: Accurate Clinical Management - Najam
state: Texas
city: Stafford
country: United States
facility: Accurate Clinical Research Inc.
state: Texas
city: Webster
country: United States
facility: Medical Center Research LLC
state: Texas
city: Plovdiv
country: Bulgaria
facility: MHAT-Plovdiv AD
city: Plovdiv
country: Bulgaria
facility: Umhat Kaspela
city: Sofia
country: Bulgaria
facility: NMTH Tsar Boris III
city: Plzen
country: Czechia
facility: A-Shine s.r.o.
city: Uherske Hradiste
country: Czechia
facility: Medical Plus, S.R.O.
city: T'bilisi
country: Georgia
facility: LLC Arensia Exploratory Medicine
city: Chisinau
country: Moldova, Republic of
facility: ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital
city: Bialystok
country: Poland
facility: ClinicMed Badurski i wspolnicy Spolka Jawna
city: Kharkiv
country: Ukraine
facility: Kharkiv City Hospital 8
city: Kyiv
country: Ukraine
facility: Medical Center_Clinic of International Institute of clinical Studies
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: