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A Retrospective Observational Study on the Use of Biologics in Monotherapy 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.
 
ClinicalTrials.gov Identifier: NCT01834807
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.

Condition or disease
Rheumatoid Arthritis

Study Design
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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study on the Use of Biologicals in Monotherapy in Rheumatoid Arthritis
Study Start Date : April 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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Groups and Cohorts
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Group/Cohort
Cohort


Outcome Measures
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Primary Outcome Measures :
  1. Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice [ Time Frame: approximately 1 year ]
  2. Type of biological agents used in monotherapy in routine clinical practice [ Time Frame: approximately 1 year ]

Secondary Outcome Measures :
  1. Efficacy: Response according to DAS28-ESR/CRP, CDAJ/SDAI, SJC (28) and TJC (28) and other parameters of composite scores [ Time Frame: approximately 1 year ]
  2. Quality of life: HAQ-DI score [ Time Frame: approximately 1 year ]
  3. Safety of biologics used in monotherapy: Incidence of adverse events [ Time Frame: approximately 1 year ]

Eligibility Criteria
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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
Patients with rheumatoid arthritis who are currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Diagnosis of rheumatoid arthritis
  • Currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)

Exclusion Criteria:

  • Concomitant treatment with disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis
  • Patients that have started their current monotherapy before 01/01/2009
Contacts and Locations
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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): NCT01834807


Locations
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Belgium
Aalst, Belgium, 9300
Bruxelles, Belgium, 1070
Edegem, Belgium, 2650
Genk, Belgium, 3600
Gent, Belgium, 9000
Haine-Saint-Paul, Belgium, 7100
Kortrijk, Belgium, 8500
Liège, Belgium, 4000
Merksem, Belgium, 2170
Mons, Belgium, 7000
Seraing, Belgium, 4100
Turnhout, Belgium, 2300
Verviers, Belgium, 4800
Westmalle, Belgium, 2390
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01834807    
Other Study ID Numbers: ML28540
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
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