Study of Tocilizumab (RoActemre) Administered Subcutaneously in Participants With Rheumatoid Arthritis in Everyday Clinical Practice

Rheumatoid Arthritis Clinical Trial

— ARATA  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251860
• Other study ID #: ML29087
• Status: Completed
• Start date: May 20, 2014
• Est. completion date: July 23, 2020

Study information

• Verified date: September 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Germany	CIRI - Centrum für Innovative Diagnostik und Therapie Rheumatologie/ Immunologie (GmbH)	Frankfurt

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Chugai Pharma Europe Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

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