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

UCB Pharma12,500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

12,500

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with lymphoma

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

Time frame: 6 years

Secondary Outcomes

Number of participants with serious infections

Number of participants with serious infections during the observational period (up to 6 years)

Time frame: 6 years

Number of participants with non-lymphoma malignancies

Number of participants with non-lymphoma malignancies during the observational period (up to 6 years)

Time frame: 6 years

Number of participants with cardiovascular events

Number of participants with cardiovascular events during the observational period (up to 6 years)

Time frame: 6 years

Number of participants with thromboembolic events

Number of participants with thromboembolic events during the observational period (up to 6 years)

Time frame: 6 years

Data from ClinicalTrials.gov

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