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NCT Number: NCT01565122

An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.

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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

Helsinki, Finland

Loading trial locations.

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
  • Moderate to severe rheumatoid arthritis
  • Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011

Exclusion criteria

  • RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B
  • Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
  • Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Treatment and study plan

Primary outcomes

  1. Proportion of patients on RoActemra/Actemra treatment at 6 months

    Time frame: approximately 2.5 years

Secondary outcomes

  1. Rates of dose modifications/interruptions

    Time frame: approximately 2.5 years

  2. Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment

    Time frame: approximately 2.5 years

  3. Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR

    Time frame: approximately 2.5 years

  4. Efficacy: Monotherapy versus combination therapy

    Time frame: approximately 2.5 years

  5. Safety: Incidence of adverse events

    Time frame: approximately 2.5 years

  6. Quality of life: Patient global assessment of disease activity/VAS-Fatigue/VAS-Pain scales

    Time frame: approximately 2.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Observational, Non-interventional, Multi-national Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 28, 2012
Registry last updated
Nov 2, 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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