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

Rheumatoid Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095393
• Other study ID #: RA0005
• Status: Completed
• Start date: September 1, 2009
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12500
• Est. completion date: December 31, 2019
• Est. primary completion date: December 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Collagen Diseases
• Rheumatic Diseases
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
UCB Pharma	National Data Bank for Rheumatic Diseases (NDB)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with lymphoma	Number of participants with lymphoma during the observational period (up to 6 years)	6 years
Secondary	Number of participants with serious infections	Number of participants with serious infections during the observational period (up to 6 years)	6 years
Secondary	Number of participants with non-lymphoma malignancies	Number of participants with non-lymphoma malignancies during the observational period (up to 6 years)	6 years
Secondary	Number of participants with cardiovascular events	Number of participants with cardiovascular events during the observational period (up to 6 years)	6 years
Secondary	Number of participants with thromboembolic events	Number of participants with thromboembolic events during the observational period (up to 6 years)	6 years