Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis
Summary
The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.
Timeline
- Start
- 2008-02
- Primary completion
- 2011-05
- Completion
- 2011-08
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo vs 150 mg DAC HYP; p <0.0001; Rate Ratio 0.461 (95% CI 0.318 to 0.668) NCT00390221 ↗
registry analysis (superiority or other test); Placebo vs 300 mg DAC HYP; p = 0.0002; Rate Ratio 0.503 (95% CI 0.352 to 0.721) NCT00390221 ↗
paper The annualised relapse rate was lower for patients given daclizumab HYP 150 mg (0·21, 95% CI 0·16-0·29; 54% reduction, 95% CI 33-68%; p<0·0001) PMID 23562009 ↗
release “SELECT Study Demonstrates Significant Reductions in Annualized Relapse Rate” biogen.com ↗
Publications
- Huss DJ, Mehta DS, Sharma A, You X, Riester KA, Sheridan JP, Amaravadi LS, Elkins JS, Fontenot JD. In vivo maintenance of human regulatory T cells during CD25 blockade. J Immunol. 2015 Jan 1;194(1):84-92. doi: 10.4049/jimmunol.1402140.
- Gold R, Giovannoni G, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, Robinson R, Riester K, Rana J, Elkins J, O'Neill G; SELECT study investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Jun 22;381(9884):2167-75. doi: 10.1016/S0140-6736(12)62190-4. Epub 2013 Apr 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclizumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Daclizumab | Monoclonal antibody | 300 mg | Subcutaneous |