drugset / Trial / NCT02862574
Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2016-12-15
- Primary completion
- 2017-06-26
- Completion
- 2017-08-07
Outcome
Outcome not reported
Stopped: “Study was terminated by sponsor and decision was not due to any safety signals.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Andecaliximab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Andecaliximab | Monoclonal antibody | 300 mg | Subcutaneous |
| Background | Adalimumab | Monoclonal antibody | — | Subcutaneous |
| Background | Certolizumab | Protein / enzyme biologic | — | Subcutaneous |
| Background | Etanercept | Protein / enzyme biologic | — | Subcutaneous |
| Background | Golimumab | Monoclonal antibody | — | Subcutaneous |
| Background | Methotrexate | Small molecule | — | Oral |