Clinical trial NCT01613378: A Non-Interventional Study in Rheumatoid Arthritis Patients Treated With Tocilizumab (RoActemra/Actemra)
Official title: A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
timeFrame: At 6 months
Secondary outcomes:
measure: Change From Baseline in Tender Joint Count (TJC)
timeFrame: From baseline to Month 12
measure: Change From Baseline in Swollen Joint Count (SJC)
timeFrame: From baseline to Month 12
measure: Change From Baseline in Disease Activity Score 28 (DAS28)
timeFrame: From baseline to Month 12
measure: Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)
timeFrame: From baseline to Month 12
measure: Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)
timeFrame: From baseline to Month 12
measure: Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)
timeFrame: From baseline to Month 12
measure: Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)
timeFrame: From baseline to Month 12
measure: Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)
timeFrame: From baseline to Month 12
measure: Change From Baseline in C-Reactive Protein (CRP)
timeFrame: From baseline to Month 12
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: From baseline to Month 12
measure: Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months
timeFrame: At 12 months
measure: Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months
timeFrame: At 12 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Nanaimo
country: Canada
state: British Columbia
city: Penticton
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: St John's
country: Canada
state: Newfoundland and Labrador
city: St John's
country: Canada
state: Newfoundland and Labrador
city: Lunenburg
country: Canada
state: Nova Scotia
city: Sydney
country: Canada
state: Nova Scotia
city: Brampton
country: Canada
state: Ontario
city: Burlington
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: St. Catharines
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Pointe-claire
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Rimouski
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: St-eustache
country: Canada
state: Quebec
city: Trois-rivières
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.