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NCT Number: NCT02251860

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIRI - Centrum für Innovative Diagnostik und Therapie Rheumatologie/ Immunologie (GmbH)

Frankfurt, 60528, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants

    Time frame: Up to Week 104

Secondary outcomes

  1. Change from Baseline in Mean DAS28-ESR Score

    Time frame: Baseline up to Week 104

  2. Percentage of Participants with Continuation of Tocilizumab

    Time frame: Up to Week 104

  3. Mean Retention Time of Tocilizumab

    Time frame: Up to Week 104

  4. Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment

    Time frame: From Baseline up to tocilizumab treatment discontinuation (Up to Week 104)

  5. Percentage of Participants with Concomitant Treatment with Methotrexate (MTX)

    Time frame: Up to Week 104

  6. Percentage of Participants with Low Disease Activity Defined by DAS28-ESR

    Time frame: Up to Week 104

  7. Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI)

    Time frame: Up to Week 104

  8. Percentage of Participants with Low Disease Activity Defined by CDAI

    Time frame: Up to Week 104

  9. Change from Baseline in Mean CDAI Score

    Time frame: Baseline up to Week 104

  10. Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response

    Time frame: At Month 3 and Month 6

  11. Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs)

    Time frame: Up to Week 104

  12. Mean Dose Used for Concomitant GCs

    Time frame: Up to Week 104

  13. Percentage of Participants with Dose Reduction for Concomitant GCs

    Time frame: Up to Week 104

  14. Treatment Satisfaction Visual Analogue Scale (VAS)

    Time frame: Up to Week 104

  15. Treatment User-Friendliness VAS

    Time frame: Up to Week 104

  16. Percentage of Participants with Treatment Adherence

    Time frame: Up to Week 104

  17. Response to Follow-up Treatment in Case of Switch from Tocilizumab

    Time frame: Up to Week 104

  18. Percentage of Participants with Adverse Events During Follow-up Treatment

    Time frame: Up to Week 104

  19. Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

    Time frame: Up to Week 104

  20. Hannover Functional Ability Questionnaire (FFbH) Score

    Time frame: Up to Week 104

  21. Percentage of Participants by Type of Physical Exercise

    Time frame: Up to Week 104

  22. Percentage of Participants by Frequency of Physical Exercise

    Time frame: Up to Week 104

  23. Percentage of Participants by Duration of Physical Exercise

    Time frame: Up to Week 104

  24. Fatigue-VAS

    Time frame: Up to Week 104

  25. Sleep Disturbance-VAS

    Time frame: Up to Week 104

  26. State-Trait Anxiety Inventory (STAI) Questionnaire

    Time frame: Up to Week 104

  27. Beck Depression Inventory (BDI) Questionnaire

    Time frame: Up to Week 104

  28. Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA)

    Time frame: Up to Week 104

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Chugai Pharma Europe Ltd.

Registry information

Official study 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)

Acronym: ARATA

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2014
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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