Canakinumab for Treatment of Adult-Onset Still's Disease to Achieve Reduction of Arthritic Manifestation (CONSIDER): phase II, randomised, double-blind, placebo-controlled, multicentre, investigator-initiated trial.

ABSTRACT:

Background

Inhibition of interleukin (IL)-1 represents a promising treatment option in adult-onset Still's disease (AOSD).

Objective

To investigate the efficacy and safety of canakinumab in patients with AOSD and active joint involvement by means of a multicentre, double-blind, randomised, placebo-controlled trial.

Methods

Patients with AOSD and active joint involvement (tender and swollen joint counts of ≥4 each) were treated with canakinumab (4 mg/kg, maximum 300 mg subcutaneous every 4 weeks) or placebo. The primary endpoint was the proportion of patients with a clinically relevant reduction in disease activity at week 12 as determined by the change in disease activity score (ΔDAS28>1.2).

Results

At enrolment, patients had high active disease with a mean DAS

SUBMITTER: Kedor C 

PROVIDER: S-EPMC7392486 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature