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

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ClinicalTrials.gov Identifier: NCT01770834
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease
Rheumatoid Arthritis

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Study Type : Observational
Estimated Enrollment : 100 participants
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
Actual Study Start Date : April 18, 2013
Actual Primary Completion Date : January 25, 2017
Actual Study Completion Date : January 25, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort



Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 3 years ]
  3. Treatment regimens: Concomitant medications [ Time Frame: approximately 3 years ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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

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


Locations
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Kuwait
Safat, Kuwait, 13041
Lebanon
Beirut, Lebanon, 11-236
Beirut, Lebanon, 470 Hazmieh
Beirut, Lebanon, 961
Beirut, Lebanon, 99999
Beirut, Lebanon
Jbeil, Lebanon, 1401
Saida, Lebanon, 652
Tripoli, Lebanon, 371 Tripoli
Qatar
Doha, Qatar, 3050
United Arab Emirates
Dubai, United Arab Emirates, P.O. Box 31500
Dubai, United Arab Emirates, P.O. Box 8179
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01770834    
Other Study ID Numbers: ML25533
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases