Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis

Summary

Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health problem. The purpose of this study is to determine the safety and effectiveness of lovastatin for controlling inflammation in mildly active RA.

Timeline

Start

2007-11-06

Primary completion

2012-04-30

Completion

2012-04-30

Outcome

Missed primary endpoint

Stopped (Enrollment): “Slow enrollment \&Study Drug Expiration (Target: 40 randomized participants /arm)”

registry analysis (unspecified test); Lovastatin 80 mg vs Placebo; p = 0.79; ANCOVA; NCT00302952 ↗

paper No significant difference in mean log CRP reduction between the two groups was observed PMID 31628482 ↗

Publications

• Background Abud-Mendoza C, de la Fuente H, Cuevas-Orta E, Baranda L, Cruz-Rizo J, Gonzalez-Amaro R. Therapy with statins in patients with refractory rheumatic diseases: a preliminary study. Lupus. 2003;12(8):607-11. doi: 10.1191/0961203303lu429oa.
• Background McCarey DW, McInnes IB, Madhok R, Hampson R, Scherbakov O, Ford I, Capell HA, Sattar N. Trial of Atorvastatin in Rheumatoid Arthritis (TARA): double-blind, randomised placebo-controlled trial. Lancet. 2004 Jun 19;363(9426):2015-21. doi: 10.1016/S0140-6736(04)16449-0.
• Results Aranow C, Cush J, Bolster MB, Striebich CC, Dall'era M, Mackay M, Olech E, Frech T, Box J, Keating R, Wasko MC, St Clair W, Kivitz A, Huang W, Ricketts P, Welch B, Callahan S, Spychala M, Boyle K, York K, Keyes-Elstein L, Goldmuntz E, Diamond B, Davidson A. A double-blind, placebo-controlled, phase II, randomized study of lovastatin therapy in the treatment of mildly active rheumatoid arthritis. Rheumatology (Oxford). 2020 Jul 1;59(7):1505-1513. doi: 10.1093/rheumatology/kez471.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lovastatin	Small molecule	80 mg	Oral

Indications