Statistical Analysis Plan .pdf

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Statistical Analysis Plan
Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial

Sample size
Previous IC/BPS studies demonstrated an approximate 20% placebo response rate [29].
Monotherapy response rate of certolizumab pegol in rheumatoid arthritis was 45% [21]. To
achieve an 80% power using 2:1 randomization and a 2-sided p = .05 a minimum of 39 subjects
was required. The sample size was increased by 3 subjects to account for potential participant
withdrawals.
Randomization
Eligible participants were computer randomized and received either subcutaneous certolizumab
pegol 400gm or placebo (sterile saline) in a 2:1 ratio at weeks 0, 2, 4, and 8. The study drug and
placebo were provided in ready to use syringes that were identical other than the blinded ID
number on the side of the syringe.

Statistical analysis
Any patient who withdrew from the study, for whatever reason, was classified as a nonresponder.
All statistical summaries and 2-sample t-tests were performed using the Data Desk®
version 6.3. Comparison of these changes between treatment groups are also shown as 95%
confidence intervals (CI). The chi-square test or Fisher’s exact test was applied to analyze
baseline demographics, improvement with GRA treatment responders, and the proportion of
patients with a reduction from baseline of 30% or greater in their pain intensity score between
treatment groups.


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