Rheumatoid Arthritis Clinical Trial
— ARATAOfficial title:
A Prospective, Non-Interventional Study in Germany to Evaluate the Long-Term Effectiveness and Tolerability of Subcutaneously Administered RoActemra® (Tocilizumab; TCZ) in Patients With Rheumatoid Arthritis in Daily Clinical Practice (as Recommended in Label)
NCT number | NCT02251860 |
Other study ID # | ML29087 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 20, 2014 |
Est. completion date | July 23, 2020 |
Verified date | September 2020 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1454 |
Est. completion date | July 23, 2020 |
Est. primary completion date | July 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | CIRI - Centrum für Innovative Diagnostik und Therapie Rheumatologie/ Immunologie (GmbH) | Frankfurt |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche | Chugai Pharma Europe Ltd. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants | Up to Week 104 | ||
Secondary | Change from Baseline in Mean DAS28-ESR Score | Baseline up to Week 104 | ||
Secondary | Percentage of Participants with Continuation of Tocilizumab | Up to Week 104 | ||
Secondary | Mean Retention Time of Tocilizumab | Up to Week 104 | ||
Secondary | Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment | From Baseline up to tocilizumab treatment discontinuation (Up to Week 104) | ||
Secondary | Percentage of Participants with Concomitant Treatment with Methotrexate (MTX) | Up to Week 104 | ||
Secondary | Percentage of Participants with Low Disease Activity Defined by DAS28-ESR | Up to Week 104 | ||
Secondary | Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI) | Up to Week 104 | ||
Secondary | Percentage of Participants with Low Disease Activity Defined by CDAI | Up to Week 104 | ||
Secondary | Change from Baseline in Mean CDAI Score | Baseline up to Week 104 | ||
Secondary | Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response | At Month 3 and Month 6 | ||
Secondary | Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs) | Up to Week 104 | ||
Secondary | Mean Dose Used for Concomitant GCs | Up to Week 104 | ||
Secondary | Percentage of Participants with Dose Reduction for Concomitant GCs | Up to Week 104 | ||
Secondary | Treatment Satisfaction Visual Analogue Scale (VAS) | Up to Week 104 | ||
Secondary | Treatment User-Friendliness VAS | Up to Week 104 | ||
Secondary | Percentage of Participants with Treatment Adherence | Up to Week 104 | ||
Secondary | Response to Follow-up Treatment in Case of Switch from Tocilizumab | Up to Week 104 | ||
Secondary | Percentage of Participants with Adverse Events During Follow-up Treatment | Up to Week 104 | ||
Secondary | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Up to Week 104 | ||
Secondary | Hannover Functional Ability Questionnaire (FFbH) Score | Up to Week 104 | ||
Secondary | Percentage of Participants by Type of Physical Exercise | Up to Week 104 | ||
Secondary | Percentage of Participants by Frequency of Physical Exercise | Up to Week 104 | ||
Secondary | Percentage of Participants by Duration of Physical Exercise | Up to Week 104 | ||
Secondary | Fatigue-VAS | Up to Week 104 | ||
Secondary | Sleep Disturbance-VAS | Up to Week 104 | ||
Secondary | State-Trait Anxiety Inventory (STAI) Questionnaire | Up to Week 104 | ||
Secondary | Beck Depression Inventory (BDI) Questionnaire | Up to Week 104 | ||
Secondary | Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) | Up to Week 104 |
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