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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885181
• Other study ID #: GS-US-379-1582
• Secondary ID: 2016-001496-75
• Status: Completed
• Phase: Phase 2
• Start date: September 21, 2016
• Est. completion date: September 20, 2017

Study information

• Verified date: August 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 20, 2017
• Est. primary completion date: August 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Bulgaria	MHAT-Plovdiv AD	Plovdiv
Bulgaria	Umhat Kaspela	Plovdiv
Bulgaria	NMTH Tsar Boris III	Sofia
Czechia	A-Shine s.r.o.	Plzen
Czechia	Medical Plus, S.R.O.	Uherske Hradiste
Georgia	LLC Arensia Exploratory Medicine	T'bilisi
Moldova, Republic of	ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital	Chisinau
Poland	ClinicMed Badurski i wspolnicy Spolka Jawna	Bialystok
Ukraine	Kharkiv City Hospital 8	Kharkiv
Ukraine	Medical Center_Clinic of International Institute of clinical Studies	Kyiv
United States	Albuquerque Center For Rheumatology	Albuquerque	New Mexico
United States	Medical Associates of North Georgia	Canton	Georgia
United States	Omega Research Consultants	DeBary	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Center For Arthritis and Osteoporosis	Elizabethtown	Kentucky
United States	Accurate Clinical Management - Najam	Houston	Texas
United States	Sarasota Arthritis Research Center	Sarasota	Florida
United States	Accurate Clinical Research Inc.	Stafford	Texas
United States	Medical Center Research LLC	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at 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.	Baseline; Week 12
Secondary	Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at 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).	Week 12
Secondary	Percentage of Participants Who Achieved ACR50 Improvement at 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.	Week 12
Secondary	Percentage of Participants Who Achieved ACR70 Improvement at 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.	Week 12
Secondary	Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at 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.	Baseline; Week 12