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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01095393
• Lead Sponsor: UCB Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-01
• Study First Submitted: 2010-03-26
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Primary Completion: 2016-12-13
• Study Completion: 2019-12-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12500

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with lymphoma	6 years	Number of participants with lymphoma during the observational period (up to 6 years)

Secondary Outcome Measures

Name	Time	Method
Number of participants with serious infections	6 years	Number of participants with serious infections during the observational period (up to 6 years)
Number of participants with non-lymphoma malignancies	6 years	Number of participants with non-lymphoma malignancies during the observational period (up to 6 years)
Number of participants with cardiovascular events	6 years	Number of participants with cardiovascular events during the observational period (up to 6 years)
Number of participants with thromboembolic events	6 years	Number of participants with thromboembolic events during the observational period (up to 6 years)