A Multicenter, Observational, Non-interventional Study to Evaluate the Safety and Efficacy of Anti-TNF (Anti-Tumor Necrosis Factor) Alpha Therapy With Certolizumab Pegol Observed in Daily Practice in Adult Rheumatoid Arthritis (RA) Patients
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
A Multicenter, Observational, Non-interventional Study to Evaluate the Safety and Efficacy of Anti-TNF (Anti-Tumor Necrosis Factor) Alpha Therapy With Certolizumab Pegol Observed in Daily Practice in Adult Rheumatoid Arthritis (RA) Patients
The purpose of this study is to assess the clinical efficacy of Cimzia in achieving clinical
remission after two years of therapy. The observational nature of the study leaves the
therapeutic decision exclusively within the discretion of the treating physician.
Inclusion Criteria:
- Patients eligible for treatment with Cimzia as defined in EU approved SmPC
Exclusion Criteria:
- Patient previously treated with Cimzia. Patient with known hypersensitivity to any
component of Cimzia
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Remission after two years measured by reaching a Disease Activity Score 28 (DAS28) of < 2.6
Outcome Time Frame:
From baseline to 2 years
Safety Issue:
No
Principal Investigator
UCB Clinical Trial Call center
Investigator Role:
Study Director
Investigator Affiliation:
+1 877 822 9493 (UCB)
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
RA0027
NCT ID:
NCT01069419
Start Date:
October 2009
Completion Date:
December 2014
Related Keywords:
- Rheumatoid Arthritis
- Certolizumab Pegol
- Cimzia
- Arthritis
- Arthritis, Rheumatoid
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