Quality, Non clinical, Clinical, Pharmacovigilance 2.

Module 5 Clinical

Clinical response (CR 100)

Clinical remission

Week 26 Clinical remission Clinical response (CR 100)

Week 56 Clinical remission Clinical response (CR 100)

Diploma in reumatology, clinical endocrinology and clinical electrocardiography.

Clinical

17 ANNEX III

s Clinical

Week 26

for 90 daysa Week 56 Clinical remission

Percentage of subjects in clinical response and in sustained clinical response Clinical response at Week 8a Clinical response at Week 30a Sustained response (clinical response at both

Clinical experience

Clinical efficacy

Clinical aspects

Clinical Efficacy

Clinical aspects

12 Clinical efficacy

Clinical Efficacy

Clinical Experience

Clinical aspects

18 inflammatory drug and or prednisone ( 0.2 mg kg day or 10 mg maximum).

45 inflammatory drug and or prednisone ( 0.2 mg kg day or 10 mg maximum).

Clinical experience

Clinical safety

Clinical efficacy

Clinical resistance

Clinical response (CR 100)

comparisons of proportions for Humira

7 Clinical efficacy

17 Clinical efficacy

27 Clinical efficacy

37 Clinical efficacy

48 Clinical efficacy

59 Clinical efficacy

Clinical experience

Clinical Description

6 Clinical efficacy

Clinical Program

Clinical response

th plasma proteins is considered not to be clinically relevant.

Clinical Remission

9 Clinical efficacy

21 Clinical efficacy