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Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis in Australia

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01683604
First received: September 5, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from 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:
  • Proportion of patients on RoActemra/Actemra treatment [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of dose modifications/interruptions [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Efficacy: Proportion of patients on RoActemra/Actemra monotherapy [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Laboratory parameters prior to and during infective adverse events and serious adverse events [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Quality of life: HAQ-DI/VAS-Fatigue/FACIT-Fatigue/Patient Global Assessment of disease activity [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

Rheumatoid arthritis patients treated with tocilizumab

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Severe rheumatoid arthritis
  • Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
  • Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria:

  • RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
  • Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
  • Enrolled in an ongoing clinical trial and/or 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
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683604

Contacts
Contact: Please reference Study ID Number: ML28144 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Australia
Recruiting
Campsie, Australia, 2194
Recruiting
Coffs Harbour, Australia, 2450
Active, not recruiting
Heidelberg, Australia, 3084
Recruiting
Morwell, Australia, 3842
Recruiting
New Lambton, Australia, 2305
Recruiting
Shenton Park, Australia, 6008
Recruiting
Woodville, Australia, 5011
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: NCT01683604     History of Changes
Other Study ID Numbers: ML28144
Study First Received: September 5, 2012
Last Updated: May 7, 2013
Health Authority: Australia: National Health and Medical Research Council

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 May 19, 2013