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An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388309
First Posted: July 6, 2011
Last Update Posted: November 2, 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 study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 months.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DAS Evaluation of RA Activity in Patients Treated With Tocilizumab

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Disease activity score (DAS28) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • DAS 28 (subgroup on monotherapy) [ Time Frame: 12 months ]
  • DAS 28 (subgroup on 4 mg/kg dose) [ Time Frame: 12 months ]
  • Safety: Incidence of adverse events [ Time Frame: 12 months ]

Enrollment: 64
Study Start Date: July 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

  Eligibility

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 and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe active rheumatoid arthritis
  • Inadequate response or intolerance to previous therapy with one or more traditional DMARDs

Exclusion Criteria:

  • Pregnant or lactating women
  • Active infection
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Concomitant anti-TNF drugs
  • Contraindications to treatment with RoActemra/Actemra
  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): NCT01388309


Locations
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 826 06
Kosice, Slovakia, 04011
Piestany, Slovakia, 921 12
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01388309     History of Changes
Other Study ID Numbers: ML25524
First Submitted: July 4, 2011
First Posted: July 6, 2011
Last Update Posted: November 2, 2016
Last Verified: November 2016

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