Development and Implementation of a Double-Blind Corticosteroid-Tapering Regimen for a Clinical Trial
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CitationCollinson, Neil, Katie Tuckwell, Frank Habeck, Monique Chapman, Micki Klearman, and John H. Stone. 2015. “Development and Implementation of a Double-Blind Corticosteroid-Tapering Regimen for a Clinical Trial.” International Journal of Rheumatology 2015 (1): 589841. doi:10.1155/2015/589841. http://dx.doi.org/10.1155/2015/589841.
AbstractWe describe the design and operationalization of a blinded corticosteroid-tapering regimen for a randomized trial of tocilizumab in giant cell arteritis (GCA). To our knowledge, no clinical trial in any disease has ever employed a blinded corticosteroid-tapering regimen, but this was necessary to the design of our trial which is likely to be relevant to other investigations of steroid-sparing regimens. Two standardized corticosteroid-tapering regimens are required for this GCA trial: a 6-month regimen in 3 arms (taken with tocilizumab 162 mg subcutaneously weekly or every other week or with placebo) and a 12-month regimen with placebo (fourth arm). Investigators select initial prednisone doses, tapered in an open-label fashion until 20 mg/day. Doses <20 mg/day are blinded. At least 27 blinded blister packs are required to ensure blinding and encourage compliance. This permits all possible daily doses but requires ≤5 capsules/day. The number of capsules taken at any point during tapering is identical across groups. Our approach may be extrapolated to trials beyond GCA.
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