Safety and Efficacy of the Combination of Diacerein 100 mg Daily and MTX Versus MTX Alone in the Treatment of Early Rheumatoid Arthritis (RA)

Summary

To evaluate the efficacy of Diacerein 100 mg daily versus placebo in reducing rheumatoid arthritis symptoms, when added to stable oral MTX therapy in patients with active early RA. To evaluate the safety of Diacerein 100 mg daily when administrated in combination with oral MTX therapy in those patients for up to 24 weeks To investigate a potential persistent effect, 4 weeks after Diacerein treatment is stopped (carry-over effect)

Timeline

Start

2010-10

Primary completion

2012-06

Completion

2014-04

Outcome

Missed primary endpoint

paper The ACR20 response at week 24 was similar in the diacerein and placebo groups (65% vs 45%, P = .20). PMID 31104217 ↗

Publications

• Louthrenoo W, Nilganuwong S, Nanagara R, Siripaitoon B, Collaud Basset S. Diacerein for the treatment of rheumatoid arthritis in patients with inadequate response to methotrexate: a pilot randomized, double-blind, placebo-controlled add-on trial. Clin Rheumatol. 2019 Sep;38(9):2461-2471. doi: 10.1007/s10067-019-04587-1. Epub 2019 May 19.

Drugs

Indications