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

August 10, 2016 updated by: Hoffmann-La Roche

A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5M 0H4
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3G8
      • Nanaimo, British Columbia, Canada, V9R 3G9
      • Penticton, British Columbia, Canada, V2A 3G8
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Victoria, British Columbia, Canada, V8P 5P6
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1A 5E8
      • St John's, Newfoundland and Labrador, Canada, A1C 5B8
    • Nova Scotia
      • Lunenburg, Nova Scotia, Canada, B0J 2C0
      • Sydney, Nova Scotia, Canada, B1S 3N1
    • Ontario
      • Brampton, Ontario, Canada, L6T 3J1
      • Burlington, Ontario, Canada, L7L 0B7
      • Hamilton, Ontario, Canada, L8N 2B6
      • Markham, Ontario, Canada, L6B 1A1
      • Mississauga, Ontario, Canada, L5M 2V8
      • Newmarket, Ontario, Canada, L3Y 3R7
      • St. Catharines, Ontario, Canada, L2N 7E4
      • Toronto, Ontario, Canada, M5G 1X5
      • Toronto, Ontario, Canada, M4S 2B8
      • Windsor, Ontario, Canada, N8X 5A6
    • Quebec
      • Laval, Quebec, Canada, H7G 2E6
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H2L 1S6
      • Montreal, Quebec, Canada, H2L 4M1
      • Montreal, Quebec, Canada, H3T 1Y6
      • Pointe-claire, Quebec, Canada, H9R 3J1
      • Quebec City, Quebec, Canada, G1V 3M7
      • Rimouski, Quebec, Canada, G5L 8W1
      • Sherbrooke, Quebec, Canada, J1H 5N4
      • St-eustache, Quebec, Canada, J7P 4J2
      • Trois-rivières, Quebec, Canada, G8Z 1Y2
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid Arthritis Cohort
The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
Other: No intervention
No intervention administered in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
Time Frame: At 6 months
At 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to Month 12
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.
From baseline to Month 12
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.
From baseline to Month 12
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.
From baseline to Month 12
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.
From baseline to Month 12
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.
From baseline to Month 12
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.
From baseline to Month 12
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.
From baseline to Month 12
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.
From baseline to Month 12
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.
From baseline to Month 12
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.
At 12 months
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
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 5, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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