A Multi-center, Multinational, Noninterventional Study With Certolizumab Pegol in Comparison to Any Other Subcutaneous TNF Inhibitor in Two Parallel Groups in Biologic Naive Patients With Rheumatoid Arthritis
Observational Model: Cohort, Time Perspective: Prospective
Proportion of patients demonstrating persistence to the initially prescribed Tumor Necrosis Factor (TNF) inhibitor after 24 months of treatment
For a patient to be classified as persistent he or she must be classified as an early responder up to Week 12 and be continuously treated up to Week 104 with the initially prescribed Tumor Necrosis Factor (TNF) inhibitor at a dose not greater than that initially prescribed according to the Summary of Product Characteristics (SmPC) or local labeling. For the definition of persistence rate for the primary variable, patients will be classified as early responders if their Disease Activity Score 28 (Erythrocyte Sedimentation Rate) (DAS28 (ESR)) shows a reduction of ≥ 1.2 from Baseline or decreases to ≤ 3.2 (Low Disease Activity (LDA) or remission) up to Week 12. Non responders up to Week 12 will be counted as non persistent to the initially prescribed TNF inhibitor treatment. Patients who stop the initially prescribed TNF inhibitor treatment will not be counted as persistent, except if treatment with TNF inhibitor is stopped because the patient is in clinical remission.
up to Week 104
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Germany: Federal Institute for Drugs and Medical Devices