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

NCT ID: NCT01095393

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Certolizumab pegol (CZP)

Patients with RA receiving treatment with certolizumab pegol (CZP; Cimzia®)

No interventions assigned to this group

Non-biologic DMARD

Subjects with RA receiving treatment with non-biologic DMARD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Data Bank for Rheumatic Diseases (NDB)

OTHER

Sponsor Role collaborator

UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederick Wolfe, M.D.

Role: STUDY_DIRECTOR

National Data Bank for Rheumatic Disease

Other Identifiers

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RA0005

Identifier Type: -

Identifier Source: org_study_id

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