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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01277328
First received: January 13, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational, prospective, open-label, multi-center study will evaluate th e effectiveness in disease reduction and the safety of RoActemra/Actemra (tocili zumab) in patients with rheumatoid arthritis. Data will be collected for 11 mont hs.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tocilizumab (RoActemra) poST Marketing Observational Study in DMARD-IR Patients to Assess Efficacy and Safety in routiNE Clinical Practice - STONE

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in Disease Activity Score 28 (DAS28) [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with a change in Disease Activity Score 28 (DAS28) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • European League Against Rheumatism (EULAR) response rates [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with disease remission [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with low disease activity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort
Cohort

  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 receiving RoActemra/Actemra

Criteria

Inclusion Criteria:

  • Adult patients >/=18 years of age
  • Patients with rheumatoid arthritis eligible for RoActemra

Exclusion Criteria:

  • Hypersensitivity to RoActemra
  • Active, severe infections
  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: NCT01277328

Contacts
Contact: Reference Study ID Number: ML25332 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Romania
Recruiting
Bucuresti, Romania, 020983
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: NCT01277328     History of Changes
Other Study ID Numbers: ML25332
Study First Received: January 13, 2011
Last Updated: August 4, 2014
Health Authority: Romania: National Medicine and Medical Devices Agency (NMMDA)

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

ClinicalTrials.gov processed this record on August 21, 2014