Sample size and randomization
Due to the explorative character of this trial, empirical, early
clinical phase cohort sizes were used to answer the objectives of the
trial. No formal power calculation was performed. A total of 24 subjects
were studied (allocation s.c.: i.d. = 1:1); i.e., 12 subjects received
i.d. adalimumab and s.c. placebo and 12 subjects received s.c.
adalimumab and i.d. placebo. The sequence of injection, i.e., s.c.
followed by i.d. injection or i.d. injection followed by s.c. injection,
was counterbalanced. Randomization was done in 6 blocks of 4, each 4
arms containing one of each 4 arms (adalimumab s.c. followed by placebo
i.d.; placebo i.d. followed by adalimumab s.c.; placebo s.c. followed by
adalimumab i.d.; adalimumab i.d. followed by placebo s.c.). The
randomization code was generated using SAS 9.4 by a study-independent
statistician; treatment allocation was only revealed after completion of
blind data review and locking of the data. After screening and
assessment for suitability, subjects were enrolled in the trial by a
physician. Interventions were assigned to subjects by a
study-independent statistician.