A Non-Interventional Study in Rheumatoid Arthritis Patients Treated With Tocilizumab (RoActemra/Actemra)
A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab
1 other identifier
observational
200
1 country
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Typical duration for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
October 4, 2016
CompletedOctober 4, 2016
August 1, 2016
2.7 years
June 5, 2012
January 14, 2016
August 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
At 6 months
Secondary Outcomes (12)
Change From Baseline in Tender Joint Count (TJC)
From baseline to Month 12
Change From Baseline in Swollen Joint Count (SJC)
From baseline to Month 12
Change From Baseline in Disease Activity Score 28 (DAS28)
From baseline to Month 12
Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)
From baseline to Month 12
Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)
From baseline to Month 12
- +7 more secondary outcomes
Study Arms (1)
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.
Interventions
Eligibility Criteria
The study population included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Unknown Facility
Edmonton, Alberta, T5M 0H4, Canada
Unknown Facility
Kelowna, British Columbia, V1Y 3G8, Canada
Unknown Facility
Nanaimo, British Columbia, V9R 3G9, Canada
Unknown Facility
Penticton, British Columbia, V2A 3G8, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Victoria, British Columbia, V8P 5P6, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Unknown Facility
Lunenburg, Nova Scotia, B0J 2C0, Canada
Unknown Facility
Sydney, Nova Scotia, B1S 3N1, Canada
Unknown Facility
Brampton, Ontario, L6T 3J1, Canada
Unknown Facility
Burlington, Ontario, L7L 0B7, Canada
Unknown Facility
Hamilton, Ontario, L8N 2B6, Canada
Unknown Facility
Markham, Ontario, L6B 1A1, Canada
Unknown Facility
Mississauga, Ontario, L5M 2V8, Canada
Unknown Facility
Newmarket, Ontario, L3Y 3R7, Canada
Unknown Facility
St. Catharines, Ontario, L2N 7E4, Canada
Unknown Facility
Toronto, Ontario, M4S 2B8, Canada
Unknown Facility
Toronto, Ontario, M5G 1X5, Canada
Unknown Facility
Windsor, Ontario, N8X 5A6, Canada
Unknown Facility
Laval, Quebec, H7G 2E6, Canada
Unknown Facility
Montreal, Quebec, H1T 2M4, Canada
Unknown Facility
Montreal, Quebec, H2L 1S6, Canada
Unknown Facility
Montreal, Quebec, H2L 4M1, Canada
Unknown Facility
Montreal, Quebec, H3T 1Y6, Canada
Unknown Facility
Pointe-Claire, Quebec, H9R 3J1, Canada
Unknown Facility
Québec, Quebec, G1V 3M7, Canada
Unknown Facility
Rimouski, Quebec, G5L 8W1, Canada
Unknown Facility
Saint-Eustache, Quebec, J7P 4J2, Canada
Unknown Facility
Sherbrooke, Quebec, J1H 5N4, Canada
Unknown Facility
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7K 0H6, Canada
Related Publications (1)
Haraoui B, Jamal S, Ahluwalia V, Fung D, Manchanda T, Khraishi M. Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results From an Observational, Noninterventional Study. Rheumatol Ther. 2018 Dec;5(2):551-565. doi: 10.1007/s40744-018-0130-6. Epub 2018 Oct 28.
PMID: 30370468DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2012
First Posted
June 7, 2012
Study Start
February 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 4, 2016
Results First Posted
October 4, 2016
Record last verified: 2016-08