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OpenTrials
Completed

NCT Number: NCT01375478

An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis

This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Athens, Greece

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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, over 18 years of age
  • Moderate to severe rheumatoid arthritis
  • RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form

Exclusion criteria

  • Patients with rheumatic autoimmune disease other than rheumatoid arthritis
  • Patients who are not willing to sign the informed consent form
  • Patients who participate in interventional trials during the period of this observational study

Treatment and study plan

Primary outcomes

  1. Percentage of patients who remained under continued RoActemra/Actemra treatment

    Time frame: 6 months

Secondary outcomes

  1. Reasons for withdrawal

    Time frame: 6 months

  2. Frequency of withdrawal

    Time frame: 6 months

  3. Frequency of dose modification

    Time frame: 6 months

  4. Reasons for dose modification

    Time frame: 6 months

  5. Safety: Incidence of adverse events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION Study)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2011
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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