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

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:
NCT01277328
First received: January 13, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tocilizumab (RoActemra) poST Marketing Observational Study in DMARD-IR Patients to Assess Efficacy and Safety in routiNE Clinical Practice - STONE

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:
  • Mean change in Disease Activity Score 28 (DAS28) [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with a change in Disease Activity Score 28 (DAS28) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • European League Against Rheumatism (EULAR) response rates [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with disease remission [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with low disease activity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: May 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort
Cohort

  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 receiving RoActemra/Actemra

Criteria

Inclusion Criteria:

  • Adult patients >/=18 years of age
  • Patients with rheumatoid arthritis eligible for RoActemra

Exclusion Criteria:

  • Hypersensitivity to RoActemra
  • Active, severe infections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277328

Contacts
Contact: Please reference Study ID Number: ML25332 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Romania
Recruiting
Bucuresti, Romania, 020983
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: NCT01277328     History of Changes
Other Study ID Numbers: ML25332
Study First Received: January 13, 2011
Last Updated: May 7, 2013
Health Authority: Romania: National Medicine and Medical Devices Agency (NMMDA)

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 22, 2013