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Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial : The Lancet
The Lancet - Early Online Publication, 10/08/09

Comi G et al. – Early treatment with glatiramer acetate is efficacious in delaying conversion to clinically definite multiple sclerosis in patients presenting with clinically isolated syndrome and brain lesions detected by MRI.

• Randomised, double–blind trial
• 481 patients presenting with clinically isolated syndrome with unifocal manifestation, and two or more T2–weighted brain lesions measuring 6 mm or more, were randomly assigned to receive either subcutaneous glatiramer acetate 20 mg per day (n=243) or placebo (n=238) for up to 36 months, unless converted to clinically definite MS
• Randomisation scheme used SAS–based blocks stratified by centre, and patients and all personnel were masked to treatment assignment
• Primary endpoint was time to clinically definite multiple sclerosis, based on second clinical attack
• Analysis by intention to treat
• Preplanned interim analysis was done for data accumulated from 81% of the 3–year study exposure

• Glatiramer acetate reduced risk of developing clinically definite MS by 45% compared with placebo (hazard ratio 0·55, 95% CI 0·40—0·77)
• Time for 25% of patients to convert to clinically definite disease was prolonged by 115%, from 336 days for placebo to 722 days for glatiramer acetate
• Most common adverse events in glatiramer acetate group injection–site reactions (135 [56%] glatiramer acetate vs 56 [24%] placebo) and immediate post–injection reactions

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