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OpenTrials
Completed

NCT Number: NCT02101307

Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With RoActemra/Actemra (Tocilizumab)

This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment regimen will be directed by the treating physician according to clinical practice. Patients are expected to be observed for approximately 6 months after beginning 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

Beijing Union Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients at least 18 years of age
  • Patients with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria
  • Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label). This can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
  • Patient has given informed consent

Exclusion criteria

  • Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
  • Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
  • Patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • Patients with a 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 6 months after treatment initiation

    Time frame: 6 months

Secondary outcomes

  1. Proportion of patients with systemic manifestation of RA

    Time frame: At Baseline

  2. Record of RA treatment history

    Time frame: 6 months

  3. Treatment patterns during observation period, assessed by alteration in dosing regimen

    Time frame: 6 months

  4. Efficacy as assessed by total joint count evaluation

    Time frame: 6 months

  5. Incidence of adverse events

    Time frame: 6 months

  6. Health-related quality of life as assessed by questionnaire

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 2, 2014
Registry last updated
Dec 29, 2017

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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