Relating to safety:
Adverse Events-AE (Type of AE, description of AE), Time between time of administration and the occurrence of AE (hours and minutes or days), Duration of AE (date of onset and duration of AE in days or hours and (Severe / Serious or Non-Severe / Non-Severe), Intensity of AE (Mild, Moderate or Severe), Causal Relationship (Not Evaluable / Unclassifiable, Unrelated, unlikely, probable, likely, very likely / safe), Attitude followed by onset of AE (continuing or stopping treatment), EA treatment (according to AE intensity), AE outcome). Measurement time: weekly (1st month) and months 2, 3, 4, 5, 6, 9 and 12.
Relating to Pharmacokinetics:
Maximum concentration (Cmax), Time at which Cmax (Tmax) is reached, Average life time (T ½), Area under the curve (AUC). Measurement time: before starting the treatment, after the 1st dose at 30 min, at 1 hr, at 1 ½ hr, at 2 hrs, at 4 hrs, at 6 hrs, at 8 hrs, at 12 hrs, at 18 hrs and 24 hours.
Relating to the effect:
Clinical response according to ACR (ACR20, ACR50, ACR70) Measurement time: Week 28, Month 9, Month 12.
Clinical response according to DAS28 (DAS28 <2.6), Disease activity (DAS28> 2.6 and DAS28 <= 3.2), Moderate disease activity (DAS28> 3.2 and DAS28 <= 5.2), Disease activity Severe (DAS28> 5.2)). Measuring time: Week 28, Month 9, Month 12.
Sub lymphocyte populations (CD4 + CD25 + Foxp3 + by flow cytometry). Measuring time: 24 h
Determination of cytokines (TNFα, IFNγ, TGFβ, IL-1, IL-2, IL-10 and IL-17). Measuring time: Week 28, Month 9, Month 12.
Quality of life (Questionnaire SF-36). Measuring time: week 28, Month 9, Month 1