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NCT Number: NCT01613378

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

This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of 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

Edmonton, Alberta, Canada

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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
  • Moderate to severe rheumatoid arthritis according to revised (1987) American college of rheumatology (ACR) criteria
  • Initiated on tocilizumab treatment by the treating physician in accordance with the Canadian product monograph
  • Informed consent to data being subject to computerized data processing
  • Participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage

Exclusion criteria

  • Received tocilizumab prior to enrolment visit
  • Previously received tocilizumab in a clinical trial or for compassionate use
  • Enrolled in an ongoing clinical trial and/or received treatment with any investigational agent within 4 weeks, or 5 half-lives of the investigational agent, whichever is longer, before starting treatment with tocilizumab
  • Participation in another clinical trial or industry sponsored observational study
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome

Treatment and study plan

No intervention

Other

No intervention administered in this study

Primary outcomes

  1. Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation

    Time frame: At 6 months

Secondary outcomes

  1. Change From Baseline in Tender Joint Count (TJC)

    Time frame: From baseline to Month 12

    Following an assessment of 68 joints for tenderness, joints were classified as tender or not tender by the investigator.

  2. Change From Baseline in Swollen Joint Count (SJC)

    Time frame: From baseline to Month 12

    Following an assessment of 66 joints for swelling, joints were classified as swollen or not swollen by the investigator.

  3. Change From Baseline in Disease Activity Score 28 (DAS28)

    Time frame: From baseline to Month 12

    The DAS28 scale is a combined index for measuring disease activity in rheumatoid arthritis. Scores range from 0 to 10, with higher scores representing more disease activity.

  4. Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)

    Time frame: From baseline to Month 12

    With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of morning stiffness.

  5. Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)

    Time frame: From baseline to Month 12

    With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.

  6. Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)

    Time frame: From baseline to Month 12

    With VAS, physicians specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.

  7. Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)

    Time frame: From baseline to Month 12

    With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of pain.

  8. Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)

    Time frame: From baseline to Month 12

    With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of fatigue.

  9. Change From Baseline in C-Reactive Protein (CRP)

    Time frame: From baseline to Month 12

    The serum concentration of C-reactive protein (CRP) was measured. A reduction in the level of CRP was considered an improvement.

  10. Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

    Time frame: From baseline to Month 12

    The erythrocyte sedimentation rate (ESR) was analyzed at the site using the kit provided by the central laboratory. A reduction in the level of ESR was considered an improvement.

  11. Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months

    Time frame: At 12 months

    The extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants with available data.

  12. Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months

    Time frame: At 12 months

    The severity of extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants who responded "YES" to changes in extra- articular RA manifestations (new presence or change in severity) since the last visit. NA=Not applicable

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 Who Are Treated With Tocilizumab

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2012
Registry last updated
Oct 4, 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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