Skip to main content
OpenTrials
Completed

NCT Number: NCT01952509

A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) Treatment in Patients With Rheumatoid Arthritis

This multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the local label will be followed for 6 months.

Completed

Looking for future studies?

Notify Me

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

Cartago, Costa Rica

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 (1987) ACR criteria
  • Patients 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

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 the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • Patients with a 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 at 6 months after treatment initiation

    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 RoActemra/Actemra treatment

    Time frame: approximately 2 years

  3. Proportion of patients on RoActemra/Actemra monotherapy at study entry and at Month 6

    Time frame: approximately 2 years

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

    Time frame: approximately 2 years

  5. Safety: Incidence of adverse events

    Time frame: approximately 2 years

  6. Health Assessment Questionnaire Disability Index

    Time frame: approximately 2 years

  7. Visual Analogue Scale - Fatigue

    Time frame: approximately 2 years

  8. Visual Analogue Scale - severity of pain

    Time frame: approximately 2 years

  9. Visual Analogue Scale - morning stiffness

    Time frame: aproximately 2 years

  10. Patient Global Assessment of disease activity

    Time frame: approximately 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Multinational, Multicenter, Non Interventional Study, in Patients With Rheumatoid Arthritis (RA) Treated With Tocilizumab.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2013
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.