ARATA is a prospective, non-interventional, multicenter, observational study in Germany to evaluate the long-term effectiveness and tolerability of subcutaneously administered tocilizumab in participants with rheumatoid arthritis in daily clinical practice. Participants will be followed over an observation period of up to 2 years after the initial injection.
Study Type
OBSERVATIONAL
Enrollment
1,454
CIRI - Centrum für Innovative Diagnostik und Therapie Rheumatologie/ Immunologie (GmbH)
Frankfurt, Germany
Percentage of Participants with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment
Time frame: Up to Week 104
Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants
Time frame: Up to Week 104
Change from Baseline in Mean DAS28-ESR Score
Time frame: Baseline up to Week 104
Percentage of Participants with Continuation of Tocilizumab
Time frame: Up to Week 104
Mean Retention Time of Tocilizumab
Time frame: Up to Week 104
Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment
Time frame: From Baseline up to tocilizumab treatment discontinuation (Up to Week 104)
Percentage of Participants with Concomitant Treatment with Methotrexate (MTX)
Time frame: Up to Week 104
Percentage of Participants with Low Disease Activity Defined by DAS28-ESR
Time frame: Up to Week 104
Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI)
Time frame: Up to Week 104
Percentage of Participants with Low Disease Activity Defined by CDAI
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Time frame: Up to Week 104
Change from Baseline in Mean CDAI Score
Time frame: Baseline up to Week 104
Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response
Time frame: At Month 3 and Month 6
Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs)
Time frame: Up to Week 104
Mean Dose Used for Concomitant GCs
Time frame: Up to Week 104
Percentage of Participants with Dose Reduction for Concomitant GCs
Time frame: Up to Week 104
Treatment Satisfaction Visual Analogue Scale (VAS)
Time frame: Up to Week 104
Treatment User-Friendliness VAS
Time frame: Up to Week 104
Percentage of Participants with Treatment Adherence
Time frame: Up to Week 104
Response to Follow-up Treatment in Case of Switch from Tocilizumab
Time frame: Up to Week 104
Percentage of Participants with Adverse Events During Follow-up Treatment
Time frame: Up to Week 104
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Time frame: Up to Week 104
Hannover Functional Ability Questionnaire (FFbH) Score
Time frame: Up to Week 104
Percentage of Participants by Type of Physical Exercise
Time frame: Up to Week 104
Percentage of Participants by Frequency of Physical Exercise
Time frame: Up to Week 104
Percentage of Participants by Duration of Physical Exercise
Time frame: Up to Week 104
Fatigue-VAS
Time frame: Up to Week 104
Sleep Disturbance-VAS
Time frame: Up to Week 104
State-Trait Anxiety Inventory (STAI) Questionnaire
Time frame: Up to Week 104
Beck Depression Inventory (BDI) Questionnaire
Time frame: Up to Week 104
Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA)
Time frame: Up to Week 104