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NCT Number: NCT01615419

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

This multi-center, observational study will evaluate the use in clinical practice and efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

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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

Athens, Greece

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 , according to the revised ACR criteria
  • Patients initiated on RoActemra/Actemra treatment (in accordance with the local label) on their treating physicians decision

Exclusion criteria

  • RoActemra/Actemra treatment more than 8 weeks prior to enrolment visit
  • 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 investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • History of autoimmune disease or of any joint inflammatory disease other than RA

Treatment and study plan

Primary outcomes

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

    Time frame: approximately 2 years

Secondary outcomes

  1. Rates of dose modifications/interruptions

    Time frame: approximately 2 years

  2. Clinical/demographic patient characteristics at initiation of treatment

    Time frame: approximately 2 years

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

    Time frame: approximately 2 years

  4. Efficacy: Monotherapy versus combination therapy

    Time frame: approximately 2 years

  5. Use of disease-modifying anti-rheumatic drugs (DMARDs)

    Time frame: approximately 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 8, 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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