Rheumatoid Arthritis
Conditions
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.
Interventions
None listed
Sponsors
Chugai Pharma Europe Ltd.
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Participants who at the time of the study inclusion are participating in a different interventional study on rheumatoid arthritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Mean Retention Time of Tocilizumab | 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 Methotrexate (MTX) | Up to Week 104 |
| Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response | At Month 3 and Month 6 |
| Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs) | Up to Week 104 |
| Percentage of Participants with Low Disease Activity Defined by DAS28-ESR | Up to Week 104 |
| Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI) | Up to Week 104 |
| Percentage of Participants with Low Disease Activity Defined by 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 with Dose Reduction for Concomitant GCs | Up to Week 104 |
| Treatment Satisfaction Visual Analogue Scale (VAS) | Up to Week 104 |
| Treatment User-Friendliness VAS | Up to Week 104 |
| Change from Baseline in Mean DAS28-ESR Score | Baseline up to Week 104 |
| Response to Follow-up Treatment in Case of Switch from Tocilizumab | Up to Week 104 |
| Percentage of Participants with Adverse Events During Follow-up Treatment | Up to Week 104 |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Up to Week 104 |
| Hannover Functional Ability Questionnaire (FFbH) Score | Up to Week 104 |
| Percentage of Participants by Type of Physical Exercise | Up to Week 104 |
| Percentage of Participants by Frequency of Physical Exercise | Up to Week 104 |
| Percentage of Participants by Duration of Physical Exercise | Up to Week 104 |
| Fatigue-VAS | Up to Week 104 |
| Sleep Disturbance-VAS | Up to Week 104 |
| State-Trait Anxiety Inventory (STAI) Questionnaire | Up to Week 104 |
| Beck Depression Inventory (BDI) Questionnaire | Up to Week 104 |
| Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) | Up to Week 104 |
| Percentage of Participants with Treatment Adherence | Up to Week 104 |
| Percentage of Participants with Continuation of Tocilizumab | Up to Week 104 |
Countries
Germany
Outcome results
None listed