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OpenTrials
Completed

NCT Number: NCT02721004

Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis

This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Bludenz, 6700, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with rheumatoid arthritis receiving tocilizumab as per product label

Exclusion criteria

  • No specific exclusion criteria were specified for this non-interventional trial

Treatment and study plan

Tocilizumab

Drug

Tocilizumab administered as an intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.

Other names: RoActemra

Primary outcomes

  1. Disease Activity Score Based on 28-joints Count (DAS28)

    Time frame: Month 12

  2. Simplified Disease Activity Index (SDAI) Score

    Time frame: Month 12

  3. Clinical Disease Activity Index (CDAI) Score

    Time frame: Month 12

  4. Percentage of Participants Achieving American College of Rheumatology (ACR) Response

    Time frame: Month 12

  5. Tender Joint Count (TJC)

    Time frame: Month 12

  6. Swollen Joint Count (SJC)

    Time frame: Month 12

Secondary outcomes

  1. Percentage of Participants with any Adverse Event (AE)

    Time frame: Up to 36 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 28, 2016
Registry last updated
Jul 4, 2016

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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