Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Necrosis

Arthritis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Analgesics

Gastrointestinal Agents

Micronutrients

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Methotrexate

Tumor Necrosis Factor Inhibitors

Etanercept

Adalimumab

Certolizumab Pegol

Golimumab

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

Andecaliximab 300 mg for 12 weeks, in addition to their current regimen of a TNF inhibitor and methotrexate.

Andecaliximab 150 mg + placebo for 12 weeks, in addition to their current regimen of a TNF inhibitor and methotrexate.

Placebo weekly for 12 weeks, in addition to their current regimen of a TNF inhibitor and methotrexate.

On the Week 12 visit, eligible participants may choose to participate in the open-label portion of the study to receive open-label andecaliximab 300 mg for 52 weeks, in addition to their current regimen of a TNF inhibitor and methotrexate.

Administered via subcutaneous injection once weekly

Andecaliximab

Placebo

Administered orally weekly as part of the participant's current treatment regimen

An approved stable subcutaneous formulation of one of the following TNF inhibitors may include adalimumab, certolizumab, etanercept, or golimumab.

TNF Inhibitor

Gilead Study Director

The primary objective of this study is to evaluate the efficacy of andecaliximab (GS-5745) versus placebo as an add-on therapy to a tumor necrosis factor (TNF) inhibitor and methotrexate in adults with moderate to severe rheumatoid arthritis (RA).

Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid Arthritis

The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.

The plasma concentrations of andecaliximab were not collected and were not analyzed.

Gilead Sciences

Safety Analysis Set: participants who received at least 1 dose of study drug

Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Andecaliximab 300 mg (Double-Blind)

Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Andecaliximab 150 mg (Double-Blind)

Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Placebo (Double-Blind)

Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Andecaliximab 300 mg (Open-Label)

Double-Blind Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Andecaliximab 300 mg

Double-Blind Period: Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Andecaliximab 150 mg

Double-Blind Period: Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient'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 2 to 10. Higher values indicate higher disease activity.

Disease Activity Score C-reactive Protein (DAS28(CRP))

Gilead decided to discontinue the development of andecaliximab in RA and this study was terminated. The decision was not due to any safety concerns. Because only 15 participants were enrolled, no formal statistical testing was completed.

Gilead Clinical Study Information Center

Participants in the Full Analysis Set (all randomized participants who received at least 1 dose of study drug) with available data were analyzed.

Change From Baseline in DAS28(CRP) at Week 12

Full Analysis Set: all randomized participants who received at least 1 dose of study drug

Percentage of Participants That Achieve DAS28(CRP) ≤ 3.2 at Week 12

Percentage of Participants That Achieve DAS28(CRP) < 2.6 at Week 12

Plasma Concentration of Andecaliximab

Double-Blind Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a tumor necrosis factor (TNF) inhibitor and methotrexate

Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Spots Global Cancer Trial Database for Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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