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An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

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:
NCT01565122
First received: March 26, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational, Non-interventional, Multi-national 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 at 6 months [ 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: Monotherapy versus combination therapy [ 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: Patient global assessment of disease activity/VAS-Fatigue/VAS-Pain scales [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 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 initiated on RoActemra/Actemra treatment

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis
  • Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011

Exclusion Criteria:

  • RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B
  • Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
  • 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: NCT01565122

Contacts
Contact: Please reference Study ID Number: ML28207 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Finland
Recruiting
Helsinki, Finland, 00290
Recruiting
Joensuu, Finland, 80210
Recruiting
Jyväskylä, Finland, 40620
Recruiting
Kuopio, Finland, 70101
Recruiting
Lahti, Finland, 15850
Recruiting
Paimio, Finland, 21540
Recruiting
Riihimäki, Finland, 11101
Recruiting
Rovaniemi, Finland, 96101
Recruiting
Tampere, Finland, 33520
Recruiting
Vaasa, Finland, 65130
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: NCT01565122     History of Changes
Other Study ID Numbers: ML28207
Study First Received: March 26, 2012
Last Updated: May 7, 2013
Health Authority: Finland: Ethics 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 May 19, 2013