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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Data Bank for Rheumatic Diseases (NDB)
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01095393
First received: March 26, 2010
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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
Rheumatoid Arthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Number of participants with lymphoma [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
    Number of participants with lymphoma during the observational period (up to 6 years)


Secondary Outcome Measures:
  • Number of participants with serious infections [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of participants with cardiovascular events during the observational period (up to 6 years)

  • Number of participants with thromboembolic events [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
    Number of participants with thromboembolic events during the observational period (up to 6 years)


Estimated Enrollment: 12500
Study Start Date: September 2009
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01095393     History of Changes
Other Study ID Numbers: RA0005
Study First Received: March 26, 2010
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Certolizumab pegol
Immunoglobulin Fab Fragments
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014