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

July 15, 2020 updated by: UCB Pharma

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

12500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Rheumatologist referral or patient direct enrollment

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Certolizumab pegol (CZP)
Patients with RA receiving treatment with certolizumab pegol (CZP; Cimzia®)
Non-biologic DMARD
Subjects with RA receiving treatment with non-biologic DMARD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with serious infections
Time Frame: 6 years
Number of participants with serious infections during the observational period (up to 6 years)
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)
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)
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)
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Collaborators

National Data Bank for Rheumatic Diseases (NDB)

Investigators

  • Study Director: Frederick Wolfe, M.D., National Data Bank for Rheumatic Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

December 13, 2016

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 26, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA0005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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