Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02885181
• Date of registration: 26/08/2016
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
• Scientific 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
• Date of first enrolment: September 21, 2016
• Target sample size: 83
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02885181
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Czech Republic, Czechia, Georgia, Hungary, Moldova, Republic of, Poland, Ukraine, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Methotrexate

Drug: GS-9876

Drug: Filgotinib placebo

Drug: Filgotinib

Drug: GS-9876 placebo

Primary Outcome(s)

Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12 [Time Frame: Baseline; Week 12]

Secondary Outcome(s)

Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 [Time Frame: Baseline; Week 12]

Percentage of Participants Who Achieved ACR50 Improvement at Week 12 [Time Frame: Week 12]

Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12 [Time Frame: Week 12]

Percentage of Participants Who Achieved ACR70 Improvement at Week 12 [Time Frame: Week 12]

Secondary ID(s)

2016-001496-75

GS-US-379-1582

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02885181