Rheumatoid ArthritisNCT01095393
National Data Bank for Rheumatic Disease Registry Study of Safety in Patients With Rheumatoid Arthritis Treated With Cimzia® or Disease-modifying Antirheumatic Drugs (DMARDs)
An observational study of Rheumatoid Arthritis, run by UCB Pharma.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 12,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2009to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Rheumatologist referral or patient direct enrollment
Who may be able to join
- RA and started treatment with certolizumab pegol (Cimzia®; CZP) or non-biologic DMARD within the last 6 months
Who cannot join
None listed.
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Certolizumab Pegol, CZP, Cimzia®, NDB, registry
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with lymphoma
Number of participants with lymphoma during the observational period (up to 6 years)
Measured: 6 years
Secondary outcomes (4)
Number of participants with serious infections
Number of participants with serious infections during the observational period (up to 6 years)
Measured: 6 years
Number of participants with non-lymphoma malignancies
Number of participants with non-lymphoma malignancies during the observational period (up to 6 years)
Measured: 6 years
Number of participants with cardiovascular events
Number of participants with cardiovascular events during the observational period (up to 6 years)
Measured: 6 years
Number of participants with thromboembolic events
Number of participants with thromboembolic events during the observational period (up to 6 years)
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study start1 Sep 2009
- Primary completion13 Dec 2016
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Data Bank for Rheumatic Diseases (NDB)
- Responsible party
- Sponsor
- Investigators
- Frederick Wolfe, M.D., Study director, National Data Bank for Rheumatic Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095393
- Sponsor's protocol ID
- RA0005
- Status last verified
- Jul 2020
- First submitted
- 26 Mar 2010
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01095393
- Acronym / sponsor ID
- RA0005
- Conditions
- Rheumatoid Arthritis
- Keywords
- Certolizumab Pegol, CZP, Cimzia®, NDB, registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,500 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Collaborators
- National Data Bank for Rheumatic Diseases (NDB)
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 13 Dec 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Rheumatologist referral or patient direct enrollment
Key inclusion criteria (1 listed)
- RA and started treatment with certolizumab pegol (Cimzia®; CZP) or non-biologic DMARD within the last 6 months
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with lymphoma
Time frame: 6 years
Number of participants with lymphoma during the observational period (up to 6 years)
4 secondary outcomes
Number of participants with serious infections
Time frame: 6 years
Number of participants with non-lymphoma malignancies
Time frame: 6 years
Number of participants with cardiovascular events
Time frame: 6 years
Number of participants with thromboembolic events
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Wolfe, M.D. study director
National Data Bank for Rheumatic Disease
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by UCB Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with lymphoma (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.