Effects of Abatacept in Patients With Early Rheumatoid Arthritis

Summary

The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

Timeline

Start

2015-09-03

Primary completion

2017-01-16

Completion

2020-03-19

Outcome

Missed primary endpoint

paper Primary study endpoint was not met: PMID 36869251 ↗

paper 21.3% (48/225) of patients in the combination and 16.0% (24/150) in the abatacept placebo + methotrexate arm achieved SDAI remission at week 24 (p = 0.2359). PMID 36869251 ↗

Publications

• Emery P, Fleischmann R, Wong R, Lozenski K, Tanaka Y, Bykerk V, Bingham CO 3rd, Huizinga TWJ, Citera G, Perera V, Murthy B, Maxwell KF, Passarell J, Hedrich WD, Williams D. Association Between Abatacept Exposure Levels and Infection Occurrence in Patients With Rheumatoid Arthritis: Post Hoc Analysis of the AVERT-2 Study. J Rheumatol. 2025 May 1;52(5):426-435. doi: 10.3899/jrheum.2024-0498.
• Emery P, Tanaka Y, Bykerk VP, Bingham CO, Huizinga TWJ, Citera G, Huang KG, Wu C, Connolly SE, Elbez Y, Wong R, Lozenski K, Fleischmann R. The trajectory of clinical responses in patients with early rheumatoid arthritis who achieve sustained remission in response to abatacept: subanalysis of AVERT-2, a randomized phase IIIb study. Arthritis Res Ther. 2023 Apr 22;25(1):67. doi: 10.1186/s13075-023-03038-2.
• Emery P, Tanaka Y, Bykerk VP, Huizinga TWJ, Citera G, Bingham CO 3rd, Banerjee S, Soule BP, Nys M, Connolly SE, Lozenski KL, Zhuo J, Wong R, Huang KG, Fleischmann R. Sustained Remission and Outcomes with Abatacept plus Methotrexate Following Stepwise Dose De-escalation in Patients with Early Rheumatoid Arthritis. Rheumatol Ther. 2023 Jun;10(3):707-727. doi: 10.1007/s40744-022-00519-9. Epub 2023 Mar 3.
• Wu C, Hu Y, Schafer P, Connolly SE, Wong R, Nielsen SH, Bay-Jensen AC, Emery P, Tanaka Y, Bykerk VP, Bingham CO, Huizinga TW, Fleischmann R, Liu J. Baseline serum levels of cross-linked carboxy-terminal telopeptide of type I collagen predict abatacept treatment response in methotrexate-naive, anticitrullinated protein antibody-positive patients with early rheumatoid arthritis. RMD Open. 2022 Dec;8(2):e002683. doi: 10.1136/rmdopen-2022-002683.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abatacept	Other / unclassified	125 mg	Subcutaneous
Background	Methotrexate	Small molecule	15 mg	Oral

Indications