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An Observational Study of RoActemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Non-Biological DMARDs

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 8, 2012
Last updated: July 1, 2016
Last verified: July 2016
This observational study will evaluate the safety and efficacy of RoActemra (tocilizumab) in patients with active moderate to severe rheumatoid arthritis and an inadequate response to non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Data will be collected from each eligible patient initiating RoActemra treatment over 6 months.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with good or moderate response according to EULAR criteria [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Number of treatment discontinuations due to lack of efficacy [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rheumatoid arthritis and an inadequate response to DMARDs

Inclusion Criteria:

  • Adult patients, >18 years of age
  • Moderate to severe active rheumatoid arthritis (EULAR criteria)
  • Inadequate response to DMARDs
  • Initiating treatment with RoActemra according to summary of product characteristics (SPC)

Exclusion Criteria:

  • Pregnant or lactating females
  • Rheumatic autoimmune disease other than rheumatoid arthritis
  • Prior history or current inflammatory joint disease other than rheumatoid arthritis
  • Previous treatment with any biological drug used in the treatment of rheumatoid arthritis
  • Previous treatment with RoActemra/Actemra
  • Any contraindication to treatment with RoActemra/Actemra
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01617005

Podgorica, Montenegro, 81000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01617005     History of Changes
Other Study ID Numbers: ML25699 
Study First Received: June 8, 2012
Last Updated: July 1, 2016
Health Authority: Montenegro: Agency for Drugs and Medical Devices - CALIMS

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on October 21, 2016