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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01615419
First Posted: June 8, 2012
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 multi-center, observational study will evaluate the use in clinical practice and efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Resource links provided by NLM:


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 years ]

Secondary Outcome Measures:
  • Rates of dose modifications/interruptions [ Time Frame: approximately 2 years ]
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: approximately 2 years ]
  • Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: approximately 2 years ]
  • Efficacy: Monotherapy versus combination therapy [ Time Frame: approximately 2 years ]
  • Use of disease-modifying anti-rheumatic drugs (DMARDs) [ Time Frame: approximately 2 years ]

Enrollment: 60
Study Start Date: May 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

  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 initiating treatment with RoActemra/Actemra
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis , according to the revised ACR criteria
  • Patients initiated on RoActemra/Actemra treatment (in accordance with the local label) on their treating physicians decision

Exclusion Criteria:

  • RoActemra/Actemra treatment more than 8 weeks prior to enrolment visit
  • 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 investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • History of autoimmune disease or of any joint inflammatory disease other than RA
  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): NCT01615419


Locations
Greece
Athens, Greece, 11 527
Athens, Greece, 115 27
Athens, Greece, 11527
Larissa, Greece, 411 10
Patras, Greece, 26443
Patras, Greece, 265 04
Rhodes, Greece, 851 00
Thessaloniki, Greece, 546 42
Thessaloniki, Greece, 54636
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01615419     History of Changes
Other Study ID Numbers: ML28259
First Submitted: June 6, 2012
First Posted: June 8, 2012
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