NCT02862574

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Andecaliximab	Administered via subcutaneous injection once weekly
DRUG	Placebo	Administered via subcutaneous injection once weekly
DRUG	Methotrexate	Administered orally weekly as part of the participant's current treatment regimen
DRUG	TNF Inhibitor	An approved stable subcutaneous formulation of one of the following TNF inhibitors may include adalimumab, certolizumab, etanercept, or golimumab.

Timeline

• Start date: 2016-12-15
• Primary completion: 2017-06-26
• Completion: 2017-08-07
• First posted: 2016-08-11
• Last updated: 2018-06-27
• Results posted: 2018-06-27

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study