NCT01095393

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

7.3 years

First QC Date

March 26, 2010

Last Update Submit

July 15, 2020

Conditions

Rheumatoid Arthritis

Keywords

Certolizumab PegolCZPCimzia®NDBregistry

Outcome Measures

Primary Outcomes (1)

  • Number of participants with lymphoma

    Number of participants with lymphoma during the observational period (up to 6 years)

    6 years

Secondary Outcomes (4)

  • Number of participants with serious infections

    6 years

  • Number of participants with non-lymphoma malignancies

    6 years

  • Number of participants with cardiovascular events

    6 years

  • Number of participants with thromboembolic events

    6 years

Study Arms (2)

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 Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rheumatologist referral or patient direct enrollment

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Frederick Wolfe, M.D.

    National Data Bank for Rheumatic Disease

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2010

First Posted

March 30, 2010

Study Start

September 1, 2009

Primary Completion

December 13, 2016

Study Completion

December 31, 2019

Last Updated

July 16, 2020

Record last verified: 2020-07