The outcome is changes in composite scores defined by the European League against Rheumatism (EULAR) and the American College of Rheumatology criterions [16]. EULAR response was seen at least once during the 4 week period after drug injection in 89% in the Humira group. The CinnoRATM group proportion is assumed to be 0.7100 under the null hypothesis of inferiority[16]. If the CinnoRATM response rate is not 18% (δ = −0.18; non-inferiority margin) worse than Humira treatment, it will be implied to be non-inferior. Sample size 64 in both Humira and CinnoRATM groups yields 90% power to detect non-inferiority margin. The significance level of the test was targeted at 0.0250. The significance level actually achieved by this design is 0.0284.