Rituximab plus leflunomide in rheumatoid arthritis: a randomized, placebo-controlled, investigator-initiated clinical trial (AMARA study).

ABSTRACT:

Objective

To investigate the efficacy and safety of rituximab + LEF in patients with RA.

Methods

In this investigator-initiated, randomized, double-blind, placebo-controlled phase 3 trial, patients with an inadequate response to LEF who had failed one or more DMARD were randomly assigned 2:1 to i.v. rituximab 1000 mg or placebo on day 1 and 15 plus ongoing oral LEF. The primary efficacy outcome was the difference between ≥50% improvement in ACR criteria (ACR50 response) rates at week 24 (P ≤ 0.025). Secondary endpoints included ACR20/70 responses, ACR50 responses at earlier timepoints and adverse event (AE) rates. The planned sample size was not achieved due to events beyond the investigators' control.

Results

Between 13 August 2010 and 28 January 2015, 140 patients r

SUBMITTER: Behrens F 

PROVIDER: S-EPMC8566251 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature