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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01617005
First received: June 8, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This observational study will evaluate the safety and efficacy of RoActemra (toc ilizumab) in patients with active moderate to severe rheumatoid arthritis and an inadequate response to non-biologic disease-modifying anti-rheumatic drugs (DMA RDs). Data will be collected from each eligible patient initiating RoActemra tre atment over 6 months.


Condition
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
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01617005

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01617005     History of Changes
Other Study ID Numbers: ML25699
Study First Received: June 8, 2012
Last Updated: October 6, 2014
Health Authority: Montenegro: Agency for Drugs and Medical Devices - CALIMS

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

ClinicalTrials.gov processed this record on October 23, 2014