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

This study has been completed.
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01579006
First received: April 16, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This multi-center, observational study will evaluate the clinical practice patte rns, efficacy and safety of RoActemra/Actemra in patients with rheumatoid arthri tis who have had an inadequate response (or were intolerant to) treatment with n on-biological DMARDs or with one biological agent. Data will be collected from e ach eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.


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 (Actemra)

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 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of dose modifications/interruptions [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Efficacy: Monotherapy versus combination therapy [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Laboratory parameters prior to and during infective adverse events and serious adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Quality of life: HAQ-DI/VAS-Fatigue/FACIT-Fatigue/Patient Global Assessment of disease activity [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 185
Study Start Date: May 2012
Study Completion Date: March 2014
Primary Completion Date: March 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

Rheumatoid arthritis patients treated with tocilizumab

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis
  • Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
  • Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria:

  • RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
  • Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
  • Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
  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: NCT01579006

Locations
Israel
Afula, Israel, 18101
Beer Sheva, Israel, 8410101
Hadera, Israel, 38100
Haifa, Israel, 34354
Haifa, Israel, 34362
Haifa, Israel, 31048
Jerusalem, Israel, 9112001
Jerusalem, Israel, 91240
Kfar Saba, Israel, 44281
Petach Tikva, Israel, 4937211
Petach Tikva, Israel, 4941492
Ramat Gan, Israel, 5262000
Ramat-Gan, Israel, 52621
Rishon Lezion, Israel
Sponsors and Collaborators
Hoffmann-La Roche
Clalit Health Services
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01579006     History of Changes
Other Study ID Numbers: ML28164
Study First Received: April 16, 2012
Last Updated: August 4, 2014
Health Authority: Israel: Ministry of Health

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 26, 2014