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

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ClinicalTrials.gov Identifier: NCT01095393
Recruitment Status : Enrolling by invitation
First Posted : March 30, 2010
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
National Data Bank for Rheumatic Diseases (NDB)
Information provided by (Responsible Party):
UCB Pharma

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.

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Estimated Enrollment : 12500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : September 2009
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Number of participants with lymphoma [ Time Frame: 6 years ]
    Number of participants with lymphoma during the observational period (up to 6 years)


Secondary Outcome Measures :
  1. Number of participants with serious infections [ Time Frame: 6 years ]
    Number of participants with serious infections during the observational period (up to 6 years)

  2. 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)

  3. Number of participants with cardiovascular events [ Time Frame: 6 years ]
    Number of participants with cardiovascular events during the observational period (up to 6 years)

  4. Number of participants with thromboembolic events [ Time Frame: 6 years ]
    Number of participants with thromboembolic events during the observational period (up to 6 years)



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatologist referral or patient direct enrollment
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095393


Sponsors and Collaborators
UCB Pharma
National Data Bank for Rheumatic Diseases (NDB)
Investigators
Study Director: Frederick Wolfe, M.D. National Data Bank for Rheumatic Disease

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01095393     History of Changes
Other Study ID Numbers: RA0005
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by UCB Pharma:
Certolizumab Pegol
CZP
Cimzia®
NDB
registry

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Rheumatic Diseases
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs