Study of Tocilizumab (RoActemre) Administered Subcutaneously in Participants With Rheumatoid Arthritis in Everyday Clinical Practice
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT02251860
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1454
Inclusion Criteria
- Participants who have not yet been treated with tocilizumab
- Participants who have received the first injection with tocilizumab maximum 1 month before inclusion in the study and the necessary baseline data and disease characteristics are present
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Exclusion Criteria
- Participants who at the time of the study inclusion are participating in a different interventional study on rheumatoid arthritis
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Up to Week 104 Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants Up to Week 104
- Secondary Outcome Measures
Name Time Method Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Up to Week 104 Response to Follow-up Treatment in Case of Switch from Tocilizumab Up to Week 104 Percentage of Participants with Concomitant Treatment with Methotrexate (MTX) Up to Week 104 Percentage of Participants with Adverse Events During Follow-up Treatment Up to Week 104 Percentage of Participants with Dose Reduction for Concomitant GCs Up to Week 104 Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI) Up to Week 104 Change from Baseline in Mean CDAI Score Baseline up to Week 104 Mean Dose Used for Concomitant GCs Up to Week 104 Percentage of Participants by Type of Physical Exercise Up to Week 104 Percentage of Participants with Continuation of Tocilizumab Up to Week 104 Mean Retention Time of Tocilizumab Up to Week 104 Percentage of Participants with Low Disease Activity Defined by DAS28-ESR Up to Week 104 Percentage of Participants with Low Disease Activity Defined by CDAI Up to Week 104 Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response At Month 3 and Month 6 Treatment Satisfaction Visual Analogue Scale (VAS) Up to Week 104 Percentage of Participants by Frequency of Physical Exercise Up to Week 104 Sleep Disturbance-VAS Up to Week 104 Beck Depression Inventory (BDI) Questionnaire Up to Week 104 Change from Baseline in Mean DAS28-ESR Score Baseline up to Week 104 Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment From Baseline up to tocilizumab treatment discontinuation (Up to Week 104) Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs) Up to Week 104 Treatment User-Friendliness VAS Up to Week 104 Percentage of Participants with Treatment Adherence Up to Week 104 Hannover Functional Ability Questionnaire (FFbH) Score Up to Week 104 Percentage of Participants by Duration of Physical Exercise Up to Week 104 Fatigue-VAS Up to Week 104 State-Trait Anxiety Inventory (STAI) Questionnaire Up to Week 104 Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Up to Week 104
Trial Locations
- Locations (1)
CIRI - Centrum für Innovative Diagnostik und Therapie Rheumatologie/ Immunologie (GmbH)
🇩🇪Frankfurt, Germany