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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01095393

Enrollment

12500

Registered

2010-03-30

Start date

2009-09-01

Completion date

2019-12-31

Last updated

2020-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Certolizumab Pegol, CZP, Cimzia®, NDB, registry

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with lymphoma	6 years	Number of participants with lymphoma during the observational period (up to 6 years)

Secondary

Measure	Time frame	Description
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)

Outcome results