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

This study has been terminated.
(Contract terminated with Site Management Organization)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277328
First Posted: January 14, 2011
Last Update Posted: September 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in Disease Activity Score 28 (DAS28) [ Time Frame: 11 months ]

Secondary Outcome Measures:
  • Proportion of patients with a change in Disease Activity Score 28 (DAS28) [ Time Frame: 5 months ]
  • European League Against Rheumatism (EULAR) response rates [ Time Frame: 20 weeks ]
  • Proportion of patients with disease remission [ Time Frame: 20 weeks ]
  • Proportion of patients with low disease activity [ Time Frame: 20 weeks ]
  • Incidence of adverse events [ Time Frame: 11 months ]

Enrollment: 95
Study Start Date: May 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort
Cohort

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277328


Locations
Romania
Bucuresti, Romania, 020983
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01277328     History of Changes
Other Study ID Numbers: ML25332
First Submitted: January 13, 2011
First Posted: January 14, 2011
Last Update Posted: September 15, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases