A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

Summary

The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.

Timeline

Start

2023-08-15

Primary completion

2024-08-29

Completion

2024-10-29

Outcome

Missed primary endpoint

registry analysis (superiority test); Group 1: Certolizumab and Placebo vs Group 2: Certolizumab and Nipocalimab; p =0.822 NCT06028438 ↗

paper At week 12, the primary endpoint was similar between groups PMID 41781163 ↗

Publications

• Taylor PC, Schett G, Huizinga TWJ, Ibrahim F, Zhou B, Huang S, Gambale J, Wang Q, Liva SG, Leu JH, Hubbard JJ, Leonardo S, Panchakshari RA, Loza MJ, Fei K. Nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis despite prior treatment with advanced therapies: results from the phase 2a DAISY-RA study. RMD Open. 2026 Mar 4;12(1):e006464. doi: 10.1136/rmdopen-2025-006464.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Certolizumab	Protein / enzyme biologic	200 mg	Subcutaneous
Subject	Nipocalimab	Monoclonal antibody	30 mg/kg	Intravenous

Indications