title: Development and implementation of a double-blind corticosteroid-tapering regimen for a clinical trial.
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.
authors: Roche Products Ltd., Welwyn Garden City AL7 1TW, UK.
authors: Neil
authors: N
authors: Collinson
authors: Roche Products Ltd., Welwyn Garden City AL7 1TW, UK.
authors: Katie
authors: K
authors: Tuckwell
authors: F. Hoffmann-La Roche, 4070 Basel, Switzerland.
authors: Frank
authors: F
authors: Habeck
authors: Roche Products Ltd., Welwyn Garden City AL7 1TW, UK.
authors: Monique
authors: M
authors: Chapman
authors: Genentech, South San Francisco, CA 94080, USA.
authors: Micki
authors: M
authors: Klearman
authors: Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
authors: John H
authors: JH
authors: Stone