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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.
Verified November 2016 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT01770834
First Posted: January 18, 2013
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the 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 ]

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 ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 3 years ]
  • Treatment regimens: Concomitant medications [ Time Frame: approximately 3 years ]

Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770834


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

Locations
Kuwait
Active, not recruiting
Safat, Kuwait, 13041
Lebanon
Recruiting
Beirut, Lebanon, 11-236
Recruiting
Beirut, Lebanon, 470 Hazmieh
Recruiting
Beirut, Lebanon, 961
Recruiting
Beirut, Lebanon, 99999
Recruiting
Beirut, Lebanon
Recruiting
Jbeil, Lebanon, 1401
Recruiting
Saida, Lebanon, 652
Recruiting
Tripoli, Lebanon, 371 Tripoli
Qatar
Completed
Doha, Qatar, 3050
United Arab Emirates
Completed
Dubai, United Arab Emirates, P.O. Box 31500
Completed
Dubai, United Arab Emirates, P.O. Box 8179
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01770834     History of Changes
Other Study ID Numbers: ML25533
First Submitted: January 16, 2013
First Posted: January 18, 2013
Last Update Posted: November 2, 2016
Last Verified: November 2016

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


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