Development and Implementation of a Double-Blind Corticosteroid-Tapering Regimen for a Clinical Trial. (24th March 2015)

• Record Type: Journal Article
• Authors: Collinson, Neil; Tuckwell, Katie; Habeck, Frank; Chapman, Monique; Klearman, Micki; Stone, John H.
• Other Names: Kawai Shinichi Academic Editor.
• Is Part Of: International journal of rheumatology. Volume 2015(2015)
• Publication Date: 2015-03-24
• Subjects: Rheumatology -- Periodicals; Rheumatology; Rheumatology; Electronic journals; Periodicals; Periodicals; 616.723
• DOI: 10.1155/2015/589841
• Languages: English
• ISSNs: 1687-9260

Abstract

Abstract : We 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.