Development and Implementation of a Double-Blind Corticosteroid-Tapering Regimen for a Clinical Trial
Joint Authors
Stone, John H.
Collinson, Neil
Tuckwell, Katie
Habeck, Frank
Chapman, Monique
Klearman, Micki
Source
International Journal of Rheumatology
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-6, 6 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-03-24
Country of Publication
Egypt
No. of Pages
6
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Collinson, Neil& Tuckwell, Katie& Habeck, Frank& Chapman, Monique& Klearman, Micki& Stone, John H.. 2015. Development and Implementation of a Double-Blind Corticosteroid-Tapering Regimen for a Clinical Trial. International Journal of Rheumatology،Vol. 2015, no. 2015, pp.1-6.
https://search.emarefa.net/detail/BIM-1066887
Modern Language Association (MLA)
Collinson, Neil…[et al.]. Development and Implementation of a Double-Blind Corticosteroid-Tapering Regimen for a Clinical Trial. International Journal of Rheumatology No. 2015 (2015), pp.1-6.
https://search.emarefa.net/detail/BIM-1066887
American Medical Association (AMA)
Collinson, Neil& Tuckwell, Katie& Habeck, Frank& Chapman, Monique& Klearman, Micki& Stone, John H.. Development and Implementation of a Double-Blind Corticosteroid-Tapering Regimen for a Clinical Trial. International Journal of Rheumatology. 2015. Vol. 2015, no. 2015, pp.1-6.
https://search.emarefa.net/detail/BIM-1066887
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1066887