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NCT01095393 Clinical Trial

National Data Bank for Rheumatic Disease Registry Study of Safety in Patients With Rheumatoid Arthritis Treated With Cimzia® or Disease-modifying Antirheumatic Drugs (DMARDs)

Rheumatoid Arthritis Clinical Trial

Official title:
National Data Bank for Rheumatic Disease (NDB) Registry Study of Safety in Rheumatoid Arthritis (RA) Patients Treated With Certolizumab Pegol (CZP; Cimzia®) and Non-biologic Disease-modifying Antirheumatic Drug (DMARD) Therapies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01095393
Other study ID # RA0005
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2009
Est. completion date December 31, 2019

Study information
Verified date July 2020
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observational registry to assess the longer-term risk of serious infections and malignancies reported with TNFα-blocker therapy, as well as the longer-term risk of cardiovascular and thromboembolic events in adult Rheumatoid Arthritis (RA) patients treated with Cimzia® as compared to non-biologic DMARD-treated controls.

Recruitment information / eligibility
Status Completed
Enrollment 12500
Est. completion date December 31, 2019
Est. primary completion date December 13, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- RA and started treatment with certolizumab pegol (Cimzia®; CZP) or non-biologic DMARD within the last 6 months

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
UCB Pharma National Data Bank for Rheumatic Diseases (NDB)

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with lymphoma Number of participants with lymphoma during the observational period (up to 6 years) 6 years
Secondary Number of participants with serious infections Number of participants with serious infections during the observational period (up to 6 years) 6 years
Secondary Number of participants with non-lymphoma malignancies Number of participants with non-lymphoma malignancies during the observational period (up to 6 years) 6 years
Secondary Number of participants with cardiovascular events Number of participants with cardiovascular events during the observational period (up to 6 years) 6 years
Secondary Number of participants with thromboembolic events Number of participants with thromboembolic events during the observational period (up to 6 years) 6 years
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