Skip to main content
Article thumbnail
Location of Repository

Letters Annals of Internal Medicine COMMENTS AND RESPONSES Treatment of Moderate to

By To The and Omized Trial Kimball

Abstract

colleagues (1), which claims a benefit of adalimumab in hidradenitis suppurativa, raises numerous questions about its methodology history (2). First, although the authors state that the primary outcome was “prespecified, ” the trial’s history of changes on ClinicalTrials.gov notes substantial alterations on 7 May 2011, more than 2 years after the trial began (3). Specifically, the primary outcome was altered on that date from an undefined “Physician’s Global Assessment ” to “Percentage of Participants Achieving Clinical Response at Week 16. ” Another primary outcome of “Adverse Events ” at a time point of week 52 was changed to “Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16.” A secondary end point of Physician’s Global Assessment at week 52 was changed to “Percentage of Participants Achieving Clinical Response at Week 8. ” A secondary outcome of “Nodule, Fistula and Abcess [sic] Improvement, ” which was not significantly improve

Year: 2013
OAI identifier: oai:CiteSeerX.psu:10.1.1.352.1861
Provided by: CiteSeerX
Download PDF:
Sorry, we are unable to provide the full text but you may find it at the following location(s):
  • http://citeseerx.ist.psu.edu/v... (external link)
  • http://annals.org/data/Journal... (external link)
  • Suggested articles


    To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.