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

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.
ClinicalTrials.gov Identifier: NCT01277328
Recruitment Status : Terminated (Contract terminated with Site Management Organization)
First Posted : January 14, 2011
Last Update Posted : September 15, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Rheumatoid Arthritis

Study Design

Study Type : Observational
Actual Enrollment : 95 participants
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
Study Start Date : May 2010
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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

Bucuresti, Romania, 020983
Sponsors and Collaborators
Hoffmann-La Roche
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 Posted: January 14, 2011    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016

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