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

This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01613378
First received: June 5, 2012
Last updated: June 11, 2013
Last verified: June 2013
History of Changes
  Purpose

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


Condition
Rheumatoid Arthritis

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 Treated With Tocilizumab

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients on RoActemra/Actemra treatment at Month 6 [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients on RoActemra/Actemra treatment at Month 12 [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Rates of dose modifications/interruptions [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Change in total swollen and tender joint counts [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]
  • Change in disease activity score (DAS 28) [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]
  • Change in patient assessment of disease activity/pain/fatigue (VAS) [ Time Frame: from baseline to Months 12 ] [ Designated as safety issue: No ]
  • Change in physician global assessment of disease activity (VAS) [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]
  • Change in duration of morning stiffness [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]
  • Change in C-reactive protein/ESR [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving therapeutic response according to DAS28/EULAR/SDAI/CDAI criteria [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Use of concomitant medication (DMARDs, NSAIDs, corticosteroids) [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Efficacy: monotherapy versus combination therapy [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 21 months ] [ Designated as safety issue: No ]
  • Change in Quality of life: HAQ/MOS SF-36/Work Limitations Questionnaires [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with rheumatoid arthritis initiating treatment with RoActemra/Actemra

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to revised (1987) ACR criteria
  • Initiated on RoActemra/Actemra treatment by the treating physician in accordance with the Canadian product monograph
  • Informed consent to data being subject to computerized data processing
  • Patient must fulfill the reimbursement criteria for treatment with RoActemra/Actemra under provincial or private health insurance coverage

Exclusion Criteria:

  • Received RoActemra/Actemra prior to enrolment visit
  • Previously received RoActemra/Actemra 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 RoActemra /Actemra
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613378

Contacts
Contact: Reference Study ID Number: ML28121 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Canada, Alberta
Recruiting
Edmonton, Alberta, Canada, T5M 0H4
Canada, British Columbia
Recruiting
Kelowna, British Columbia, Canada, V1Y 3G8
Recruiting
Nanaimo, British Columbia, Canada, V9R 3G9
Recruiting
Penticton, British Columbia, Canada, V2A 3G8
Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Recruiting
Victoria, British Columbia, Canada, V8P 5P6
Canada, Newfoundland and Labrador
Not yet recruiting
St John's, Newfoundland and Labrador, Canada, A1C 5B8
Recruiting
St John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Nova Scotia
Recruiting
Lunenburg, Nova Scotia, Canada, B0J 2C0
Recruiting
Sydney, Nova Scotia, Canada, B1S 3N1
Canada, Ontario
Recruiting
Brampton, Ontario, Canada, L6T 3J1
Recruiting
Burlington, Ontario, Canada, L7L 0B7
Recruiting
Hamilton, Ontario, Canada, L8N 2B6
Recruiting
Markham, Ontario, Canada, L6B 1A1
Recruiting
Mississauga, Ontario, Canada, L5M 2V8
Terminated
Newmarket, Ontario, Canada, L3Y 3R7
Recruiting
St. Catharines, Ontario, Canada, L2N 7E4
Recruiting
Toronto, Ontario, Canada, M5G 1X5
Recruiting
Toronto, Ontario, Canada, M4S 2B8
Recruiting
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Recruiting
Laval, Quebec, Canada, H7G 2E6
Recruiting
Montreal, Quebec, Canada, H2L 4M1
Recruiting
Montreal, Quebec, Canada, H2L 1S6
Recruiting
Montreal, Quebec, Canada, H3T 1Y6
Completed
Montreal, Quebec, Canada, H1T 2M4
Recruiting
Pointe-claire, Quebec, Canada, H9R 3J1
Recruiting
Quebec City, Quebec, Canada, G1V 3M7
Recruiting
Rimouski, Quebec, Canada, G5L 8W1
Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Terminated
St-eustache, Quebec, Canada, J7P 4J2
Terminated
Trois-rivières, Quebec, Canada, G8Z 1Y2
Canada, Saskatchewan
Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0H6
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01613378     History of Changes
Other Study ID Numbers: ML28121
Study First Received: June 5, 2012
Last Updated: June 11, 2013
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 June 17, 2013