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Israeli-based pharmaceutical firm Teva has announced positive results from a pre-planned interim analysis of PreCISe, a phase III study of glatiramer (Copaxone) in 481 patients presenting with a single clinical episode and MRI suggestive of multiple sclerosis (MS).
In the study, patients received either glatiramer 20mg/day or placebo as a subcutaneous injection and continued treatment for up to 36 months, unless a second attack was experienced and they were diagnosed with clinically definite MS (CDMS).
Patients who converted to CDMS continued the trial on active treatment for an additional two years. The primary efficacy outcome was time to CDMS, based on a second clinical attack.
The pre-planned interim analysis found that treatment with glatiramer reduced the risk of developing CDMS by 44% vs. placebo (43% placebo vs.25% glatiramer; p < 0.0001), and prolonged the quartile time to disease conversion (722 days vs. 336 days in placebo group; hazard ratio 0.56, p=0.0005).
Based on these results, it was recommended that the placebo arm of the trial be stopped, as glatiramer successfully met the efficacy endpoint of the study; and all placebo patients were given the opportunity to receive active treatment with glatiramer for two years.
Teva now plans to file a request for marketing authorisation of glatiramer in Europe, the US and Canada for the treatment of patients with a first clinical event suggestive of MS.
All patients in the study will participate in a follow-up to assess prospectively the impact of early versus delayed treatment with glatiramer on the long-term course of the disease for a total observation time of up to five years.