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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

Number of participants with lymphoma

Time frame: 6 years

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

Secondary outcomes

Number of participants with serious infections

Time frame: 6 years

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

Time frame: 6 years

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

Time frame: 6 years

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

Time frame: 6 years

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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Collaborators

National Data Bank for Rheumatic Diseases (NDB)

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2019
First posted: Mar 30, 2010
Registry last updated: Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed