It should be noted that the largest dose from the earlier clinical trial was 10mg.
here is an extract:
'In this randomised, double-blind, multicentre
study, 23 patients with moderate to severe active
rheumatoid arthritis receiving disease modifying
antirheumatic drugs were randomly allocated to
three treatment groups
receiving intravenous chaperonin 10 twice weekly
for 12 weeks at doses of 5 mg (n=8), 7?5 mg (8),
or 10 mg (7). The primary outcomes were change
in disease activity score (DAS28) and
improvement of core disease measures
(American College of Rheumatology response
score) from baseline to week 12. All analyses
were done by intention to treat. This study is
registered with the Australian Clinical Trials
Registry, number ACTRNO12606000041550.
Findings
Primary endpoint measures improved from day
14 in all groups and continued to improve to day
84. By end
of study, a 20% improvement of core disease
measures was seen in six (86%, 95% CI 43?
100), a 50% improvement in four (57%, 14?86),
and a 70% improvement in two (29%, 0?57)
patients given the highest dose of chaperonin 10.
Clinical remission (as defined by a DAS28 <2?6)
was achieved in three (13%) of 23 patients.
Three individuals dropped out during the study:
one in the 5 mg group (rheumatoid arthritis not
controlled), one in the 7?5 mg group (adverse
event), and one in the 10 mg group (lost to
follow-up). The most common adverse events
were exacerbation of rheumatoid arthritis (both
during and after the study) and upper respiratory
tract infection. Only one adverse event was
judged to be of severe intensity.
Interpretation
Chaperonin 10 seems to be well tolerated and
efficacious in treatment of the symptoms of
rheumatoid arthritis, at least in the short term.
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