Oral type II collagen treatment in early rheumatoid arthritis. A double-blind, placebo-controlled, randomized trial

Arthritis Rheum. 1996 Jan;39(1):41-51. doi: 10.1002/art.1780390106.


Objective: To investigate the efficacy of oral type II collagen in the treatment of early rheumatoid arthritis (RA).

Methods: Ninety patients with RA (disease duration < or = 3 years) were treated for 12 weeks with oral bovine type II collagen at 1 mg/day (n = 30) or 10 mg/day (n = 30) or with placebo (n = 30), in a double-blind randomized study.

Results: There were no significant difference between the 3 groups in terms of response to treatment. However, we observed a higher prevalence of responders in the type II collagen-treated groups: 7 responders in the 10-mg type II collagen group and 6 in the 1-mg group, versus 4 in the placebo group. Furthermore, 3 patients in the 10-mg type II collagen group and 1 patient in the 1-mg type II group, but no patients in the placebo group, had very good response. A total of 14 patients had to be withdrawn from the study: 2 because of side effects (nausea) and 12 because of lack of efficacy.

Conclusion: Only a minority of patients responded to treatment with oral type II collagen. These results justify further efforts to identify which patients will have good response to such therapy.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Animals
  • Arthritis, Rheumatoid / complications
  • Arthritis, Rheumatoid / pathology
  • Arthritis, Rheumatoid / therapy*
  • Cattle
  • Collagen / administration & dosage*
  • Collagen / adverse effects
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Treatment Outcome


  • Collagen