Lack of efficacy of oral bovine type II collagen added to existing therapyin rheumatoid arthritis

Objective, To investigate the efficacy of oral type II collagen (CII) in th e treatment of rheumatoid arthritis (RA), when added to existing therapy. Methods. Patients with active RA (n = 190) were randomized into a 6-month, double-blind, placebo-controlled trial, Patients continued to take their cu rrent arthritis medications. Patients received either placebo or bovine CII , 0.1 mg/day for 1 month, then 0.5 mg/day for 5 months. Results, There were no significant differences between the baseline charact eristics of either group. The primary response parameter was the American C ollege of Rheumatology (ACR) preliminary definition of improvement in RA (A CR 20). There was no statistically significant difference in the ACR 20 aft er 6 months (20.0% of placebo patients; 16.84% of bovine CII patients), The re were significant differences in several clinical variables after treatme nt, all favoring the placebo group. Conclusion. Oral solubilized bovine CII, added to existing therapy, did not improve disease activity in patients with RA.