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A Retrospective, Observational Study of RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis

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. Read our disclaimer for details. Identifier: NCT01921478
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective, Multi-center, Observational Study of Daily Practice Patterns and Outcomes of the Management of Rheumatoid Arthritis Patients Without Documented Erosions Treated With RoACTEMRA in Belgium
Study Start Date : August 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Joint erosion assessment in clinical practice [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Disease Activity Score 28 [ Time Frame: 6 months ]
  2. C-reactive protein assessment [ Time Frame: 6 months ]
  3. Swollen joint counts [ Time Frame: 6 months ]
  4. Tender joint counts [ Time Frame: 6 months ]
  5. Erythrocyte Sedimentation Rate [ Time Frame: 6 months ]
  6. Evolution of the pattern of joint erosion [ Time Frame: 6 months ]
  7. Patient's global assessment of disease activity (Visual Analogue Scale) [ Time Frame: 6 months ]

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Retrospective survey of medical records from patients with moderate to severe rheumatoid arthritis treated with RoActemra/Actemra (tocilizumab) who did not have documented erosions at the start of RoACTEMRA treatment .

Inclusion Criteria:

  • Adult patients, >=18 years of age
  • Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 >=5.1
  • Inadequate responder to at least 2 non-biological DMARDs
  • Absence of documented erosions at start of RoActemra/Actemra treatment
  • Received RoActemra/Actemra treatment for at least 6 months
  • Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit

Exclusion Criteria:

  • Contraindications for treatment with RoActemra/Actemra

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 identifier (NCT number): NCT01921478

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Aalst, Belgium, 9300
Antwerpen, Belgium, 2020
Brugge, Belgium, 8000
Bruxelles, Belgium, 1020
Gent, Belgium, 9000
Gilly, Belgium, 6060
Seraing, Belgium, 4100
Verviers, Belgium, 4800
Westmalle, Belgium, 2390
Wilrijk, Belgium, 2610
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT01921478    
Other Study ID Numbers: ML25271
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases