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A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01770834
First received: January 16, 2013
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This prospective, observational study will evaluate the efficacy, safety and tol erability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolera nt to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according t

o the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after t he last dose of study drug.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice

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 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Treatment regimens: Concomitant medications [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with moderate to severe rheumatoid arthritis and an inadequate response or intolerant to previous therapy with conventional DMARDs

Criteria

Inclusion Criteria:

  • Adult patients, >/= 21 years of age
  • Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)
  • Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
  • Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion Criteria:

  • Pregnant or lactating women
  • Contra-indication to RoActemra/Actemra treatment according to the local labelling
  • Previous treatment with tocilizumab
  • 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
  • Women of childbearing potential not using effective methods of contraception as defined by protocol
  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: NCT01770834

Contacts
Contact: Reference Study ID Number: ML25533 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Kuwait
Recruiting
Safat, Kuwait, 13041
Lebanon
Recruiting
Beirut, Lebanon, 961
Recruiting
Beirut, Lebanon, 99999
Recruiting
Beirut, Lebanon
Recruiting
Beirut, Lebanon, 470 Hazmieh
Recruiting
Beirut, Lebanon, 11-236
Recruiting
Jbeil, Lebanon, 1401
Recruiting
Saida, Lebanon, 652
Recruiting
Tripoli, Lebanon, 371 Tripoli
Qatar
Recruiting
Doha, Qatar, 3050
United Arab Emirates
Recruiting
Dubai, United Arab Emirates, P.O. Box 8179
Recruiting
Dubai, United Arab Emirates, P.O. Box 31500
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: NCT01770834     History of Changes
Other Study ID Numbers: ML25533
Study First Received: January 16, 2013
Last Updated: November 24, 2014
Health Authority: Lebanon: Ministry of Public Health

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 November 25, 2014