Clinical Research of Calorad®
& Collagen
Treatment of rheumatoid arthritis with oral type II
collagen. Results of a multicenter, double-blind, placebo-controlled
trial.
Barnett ML, Kremer JM, St Clair EW, Clegg DO, Furst D, Weisman
M, Fletcher MJ, Chasan-Taber S, Finger E, Morales A, Le
CH, Trentham DE.
Beth Israel Deaconess Medical Center, Boston, Massachusetts
02215, USA.
Objective
Oral administration of cartilage-derived type II collagen
(CII) has been shown to ameliorate arthritis in animal
models of joint inflammation, and preliminary studies
have suggested that this novel therapy is clinically beneficial
and safe in patients with rheumatoid arthritis (RA). The
present study was undertaken to test the safety and efficacy
of 4 different dosages of orally administered CII in patients
with RA.
Methods
Two hundred and seventy-four patients with active RA were
enrolled at 6 different sites and randomized to receive
placebo or 1 of 4 dosages (20, 100, 500, or 2,500 microg/day)
of oral CII for 24 weeks. Efficacy parameters were assessed
monthly. Cumulative response rates (percentage of patients
meeting the criteria for response at any time during the
study) were analyzed utilizing 3 sets of composite criteria:
the Paulus criteria, the American College of Rheumatology
criteria for improvement in RA, and a requirement for
> or = 30 per cent reduction in both swollen and tender
joint counts.
Results
Eighty-three per cent of patients completed 24 weeks of
treatment. Numeric trends in favor of the 20 microg/day
treatment group were seen with all 3 cumulative composite
measures. However, a statistically significant increase
(P = 0.035) in response rate for the 20 microg/day group
versus placebo was detected using only the Paulus criteria.
The presence of serum antibodies to CII at baseline was
significantly associated with an increased likelihood
of responding to treatment. No treatment-related adverse
events were detected. The efficacy seen with the lowest
dosage is consistent with the findings of animal studies
and with known mechanisms of oral tolerance in which lower
doses of orally administered autoantigens preferentially
induce disease-suppressing regulatory cells.
Conclusion
Positive effects were observed with CII at the lowest
dosage tested, and the presence of serum antibodies to
CII at baseline may predict response to therapy. No side
effects were associated with this novel therapeutic agent.
Further controlled studies are required to assess the
efficacy of this treatment approach.
Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial
PMID: 9485087 [PubMed - indexed for MEDLINE]
Studies/Articles/Abstacts
Effects of oral administration of type II collagen on
rheumatoid arthritis
Comment in:
Science. 1993 Sep 24;261(5129):1669-70.
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