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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01613378
First received: June 5, 2012
Last updated: August 10, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Rheumatoid Arthritis
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation [ Time Frame: At 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Tender Joint Count (TJC) [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
    Following an assessment of 68 joints for tenderness, joints were classified as tender or not tender by the investigator.

  • Change From Baseline in Swollen Joint Count (SJC) [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
    Following an assessment of 66 joints for swelling, joints were classified as swollen or not swollen by the investigator.

  • Change From Baseline in Disease Activity Score 28 (DAS28) [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS) [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS) [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS) [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS) [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS) [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in C-Reactive Protein (CRP) [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
    The serum concentration of C-reactive protein (CRP) was measured. A reduction in the level of CRP was considered an improvement.

  • Change From Baseline in Erythrocyte Sedimentation Rate (ESR) [ Time Frame: From baseline to Month 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    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


Enrollment: 200
Study Start Date: February 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613378

Locations
Canada, Alberta
Edmonton, Alberta, Canada, T5M 0H4
Canada, 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
Canada, Newfoundland and Labrador
St John's, Newfoundland and Labrador, Canada, A1A 5E8
St John's, Newfoundland and Labrador, Canada, A1C 5B8
Canada, Nova Scotia
Lunenburg, Nova Scotia, Canada, B0J 2C0
Sydney, Nova Scotia, Canada, B1S 3N1
Canada, 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, M4S 2B8
Toronto, Ontario, Canada, M5G 1X5
Windsor, Ontario, Canada, N8X 5A6
Canada, 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
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7K 0H6
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01613378     History of Changes
Other Study ID Numbers: ML28121 
Study First Received: June 5, 2012
Results First Received: January 14, 2016
Last Updated: August 10, 2016
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on December 07, 2016