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

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 8, 2012
Last updated: April 7, 2014
Last verified: April 2014

This observational study will evaluate the safety and efficacy of RoActemra/Actemra (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/Actemra 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 ]

Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
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/Actemra 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
Please refer to this study by its identifier: NCT01617005

Contact: Reference Study ID Number: ML25699 888-662-6728 (U.S. Only)

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

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01617005     History of Changes
Other Study ID Numbers: ML25699
Study First Received: June 8, 2012
Last Updated: April 7, 2014
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 April 23, 2014