GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Summary of Disease Activity According to CDAI

In order to calculate the Clinical Disease Activity Index (CDAI) the number of tender and swollen joints were assessed using the 28 -joint count (tender28 and swollen28). The patient's global assessment of disease activity and the physician's global assessment of disease activity were measured using a Visual Analogue Scale (VAS) of 10 cm (from 0=best to 10=worst). CDAI = tender28 + swollen28 + patient's global assessment (in cm) + physician's global assessment (in cm)

Time frame: At week 24

Summary of Disease Activity According to SDAI

In order to calculate the Simplified Disease Activity Index (SDAI) the number of tender and swollen joints were assessed using the 28 -joint count (tender28 and swollen28). The patient's global assessment of disease activity and the physician's global assessment of disease activity were measured using a Visual Analogue Scale (VAS) of 10 cm (from 0=best to 10=worst). SDAI = CDAI + CRP (in mg/dL) (CDAI = tender28 + swollen28 + patient's global assessment (in cm) + physician's global assessment (in cm))

Time frame: At week 24

Participant Response as Assessed by EULAR Response Criteria

Present DAS28 ≤ 3.2 (low): good response (if improvement \> 1.2), moderate response (if improvement \>0.6 and ≤ 1.2), no response (if improvement ≤ 0.6). Present DAS28 \> 3.2 to ≤ 5.1 (moderate): moderate response (if improvement \> 1.2), moderate response (if improvement \>0.6 and ≤ 1.2), no response (if improvement ≤ 0.6). Present DAS28 \> 5.1 (high): moderate response (if improvement \> 1.2), no response (if improvement \>0.6 and ≤ 1.2), no response (if improvement ≤ 0.6).

Time frame: At week 24