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)

Hoffmann-La Roche1 site in 1 country1,454 target enrollmentMay 20, 2014

ConditionsRheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 1454
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 20, 2014

End Date

July 23, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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 Adverse Events During Follow-up Treatment(Up to Week 104)
Percentage of Participants with Dose Reduction for Concomitant GCs(Up to Week 104)
Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA)(Up to Week 104)
Percentage of Participants with Concomitant Treatment with Methotrexate (MTX)(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)