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NCT Number: NCT01921478

A Retrospective, Observational Study of RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis

This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.

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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

Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >=18 years of age
  • Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 >=5.1
  • Inadequate responder to at least 2 non-biological DMARDs
  • Absence of documented erosions at start of RoActemra/Actemra treatment
  • Received RoActemra/Actemra treatment for at least 6 months
  • Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit

Exclusion criteria

  • Contraindications for treatment with RoActemra/Actemra

Treatment and study plan

Primary outcomes

  1. Joint erosion assessment in clinical practice

    Time frame: 6 months

Secondary outcomes

  1. Disease Activity Score 28

    Time frame: 6 months

  2. C-reactive protein assessment

    Time frame: 6 months

  3. Swollen joint counts

    Time frame: 6 months

  4. Tender joint counts

    Time frame: 6 months

  5. Erythrocyte Sedimentation Rate

    Time frame: 6 months

  6. Evolution of the pattern of joint erosion

    Time frame: 6 months

  7. Patient's global assessment of disease activity (Visual Analogue Scale)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Retrospective, Multi-center, Observational Study of Daily Practice Patterns and Outcomes of the Management of Rheumatoid Arthritis Patients Without Documented Erosions Treated With RoACTEMRA in Belgium

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 13, 2013
Registry last updated
Aug 13, 2013

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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