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Completed

NCT Number: NCT01483326

An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)

This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and further patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be collected from each patient for up to 4 years.

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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

Jan Van Breemen Instituut, Amsterdam, Netherlands

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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
  • Participants in the ACT-SURE trial, or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra

Exclusion criteria

  • Contra-indications for RoActemra/Actemra

Treatment and study plan

Primary outcomes

  1. Change in disease activity score (DAS 28)

    Time frame: baseline and up to 4 years

Secondary outcomes

  1. Change in disability, assessed by Health Assessment Questionnaire (HAQ)

    Time frame: baseline and up to 4 years

  2. Change in concomitant medication (especially tapering of steroids)

    Time frame: baseline and up to 4 years

  3. Change in dosage schedule (modification/interruption/discontinuation)

    Time frame: baseline and up to 4 years

  4. Safety: Incidence of adverse events

    Time frame: up to 4 years

  5. Response (DAS 28) according to patient-related factors (C-reactive protein, rheumatoid factor, inadequate response to anti-TNF/DMARDs, duration of illness)

    Time frame: up to 4 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

FAct: A Non-interventional Multi-center Study to Follow Patients Starting With RoActemra Assessing the Long Term Efficacy, Effectiveness and Safety of RoActemra

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2011
Registry last updated
May 1, 2019

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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