Rheumatoid Arthritis Clinical Trial
Official title:
Study of Clinical Management and Profile of Patients With Rheumatoid Arthritis Treated With Biological Therapies in Monotherapy
This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.
Status | Completed |
Enrollment | 210 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients, >/=18 years of age - Patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) or other biological drugs - Patients treated with biologic DMARDs alone for at least 6 months Exclusion Criteria: - Patients not willing or unable to give written informed consent for participation in this study - Patients who are participating in any clinical trial at the time of this study |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical and demographic patient characteristics in clinical practice at initiation of treatment | 12 months | No | |
Secondary | Disease Activity Score 28 (DAS28) | 12 months | No | |
Secondary | Safety: incidence of adverse events | 12 months | No |
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