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

NCT02885181 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: GS-US-379-15822016-001496-75
• Study Type: interventional
• Target: 83
• Locations: 7 countries
• Sites: 19

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12

  Week 12

• Percentage of Participants Who Achieved ACR50 Improvement at Week 12

  Week 12

• Percentage of Participants Who Achieved ACR70 Improvement at Week 12

  Week 12

• Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12

  Baseline; Week 12

Study Arms (4)

GS-9876 - 30 mg

EXPERIMENTAL

GS-9876 30 mg + filgotinib placebo for 12 weeks

Drug: GS-9876; Drug: Filgotinib placebo; Drug: Methotrexate

GS-9876 - 10 mg

EXPERIMENTAL

GS-9876 10 mg + filgotinib placebo for 12 weeks

Drug: GS-9876; Drug: Filgotinib placebo; Drug: Methotrexate

Filgotinib

EXPERIMENTAL

Filgotinib + GS-9876 placebo for 12 weeks

Drug: Filgotinib; Drug: GS-9876 placebo; Drug: Methotrexate

Placebo

PLACEBO COMPARATOR

GS-9876 placebo + filgotinib placebo for 12 weeks

Drug: GS-9876 placebo; Drug: Filgotinib placebo; Drug: Methotrexate

Interventions

GS-9876 DRUG

One tablet administered orally once daily

GS-9876 - 10 mg; GS-9876 - 30 mg

Filgotinib DRUG

Two tablets administered orally once daily

Filgotinib

GS-9876 placebo DRUG

One tablet administered orally once daily

Filgotinib; Placebo

Filgotinib placebo DRUG

Two tablets administered orally once daily

GS-9876 - 10 mg; GS-9876 - 30 mg; Placebo

Methotrexate DRUG

Background therapy with methotrexate administered orally or parenterally once weekly

Filgotinib; GS-9876 - 10 mg; GS-9876 - 30 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (19)

Omega Research Consultants

DeBary, Florida, 32713, United States

Location

Sarasota Arthritis Research Center

Sarasota, Florida, 34239, United States

Location

Medical Associates of North Georgia

Canton, Georgia, 30114, United States

Location

Center For Arthritis and Osteoporosis

Elizabethtown, Kentucky, 42701, United States

Location

Albuquerque Center For Rheumatology

Albuquerque, New Mexico, 87102, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Accurate Clinical Management - Najam

Houston, Texas, 77084, United States

Location

Accurate Clinical Research Inc.

Stafford, Texas, 77477, United States

Location

Medical Center Research LLC

Webster, Texas, 77598, United States

Location

MHAT-Plovdiv AD

Plovdiv, 4000, Bulgaria

Location

Umhat Kaspela

Plovdiv, 4003, Bulgaria

Location

NMTH Tsar Boris III

Sofia, 1233, Bulgaria

Location

A-Shine s.r.o.

Pilsen, 31200, Czechia

Location

Medical Plus, S.R.O.

Uherské Hradiště, 68601, Czechia

Location

LLC Arensia Exploratory Medicine

Tbilisi, 0112, Georgia

Location

ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital

Chisinau, MD-2025, Moldova

Location

ClinicMed Badurski i wspolnicy Spolka Jawna

Bialystok, 15-879, Poland

Location

Kharkiv City Hospital 8

Kharkiv, 140176, Ukraine

Location

Medical Center_Clinic of International Institute of clinical Studies

Kyiv, 2068, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

GLPG0634; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: August 31, 2016
• Study Start: September 21, 2016
• Primary Completion: August 22, 2017
• Study Completion: September 20, 2017
• Last Updated: September 19, 2018
• Results First Posted: September 19, 2018

Record last verified: 2018-08

Locations

US (9); BU (3); MO (1); CZ (2); PL (1); UA (2); GE (1)