Arthritis, RheumatoidPhase 4NCT01072058
Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
A Phase 4 study testing TNF blockers (infliximab, adalimumab, etanercept) in people with Arthritis, Rheumatoid and Spondylitis, Ankylosing, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine possible alterations in cardiac function in patients with Rheumatoid Arthritis and Ankylosing Spondylitis under anti-TNF therapy, without clinical heart disfunction at baseline, using highly sensitive non-invasive methods. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arthritis, Rheumatoid, Spondylitis, Ankylosing
- What is being tested?
- TNF blockers (infliximab, adalimumab, etanercept)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Feb 2011
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Rheumatoid Arthritis eligible to receive TNF blockers
- Diagnosis of Ankylosing Spondylitis eligible to receive TNF blockers
Who cannot join
- Clinical heart failure
- Chagas'disease
- Stable or unstable angina
- Past history of myocardial infarct
- Systemic árterial hypertension (grade 3)
- Valvulopathy
- Chronic kidney disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo
São Paulo, São Paulo
About this study
Official title: Prospective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
The purpose of this study is to determine possible alterations in cardiac function in patients with Rheumatoid Arthritis and Ankylosing Spondylitis under anti-TNF therapy, without clinical heart disfunction at baseline, using highly sensitive non-invasive methods.
- Conditions
- Arthritis, Rheumatoid, Spondylitis, Ankylosing
- Being tested
- TNF blockers (infliximab, adalimumab, etanercept)
- Keywords
- Infliximab, Adalimumab, Etanercept, Heart failure, Diastolic disfunction, TNF blocker, Anti-TNF, Echocardiography, Tissue doppler imaging, Brain Natriuretic Peptide, NT-proBNP
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF blockers (infliximab, adalimumab, etanercept)Drug
Subjects enrolled, who were eligible to anti-TNF therapy, were evaluated by echocardiography (conventional and tissue doppler imaging)and biomarkers (NT-proBNP and troponin T)at baseline. Then, they were treated with adalimumab 40mg subcutaneously every 2 weeks or infliximab 3 or 5mg/Kg (0, 2 and 6 weeks and thereafter every 8 weeks)or etanercept 50mg subcutaneously every week. And they were re-evaluated with 6, 12, 18 and 24 months from first dose of the TNF blocker .
| Study group | Role | What they receive |
|---|---|---|
| TNF blockers | Other | Not described Receives: Drug: TNF blockers (infliximab, adalimumab, etanercept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development, deterioration ou improvement of subclinical heart dysfunction
Measured: 0, 6 ,12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Moraes, MD, University of Sao Paulo
- Investigators
- Eloisa S.D.O. Bonfá, MD, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072058
- Sponsor's protocol ID
- CapPesq1252/07
- Status last verified
- Jun 2013
- First submitted
- 18 Feb 2010
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
- ClinicalTrials.gov ID
- NCT01072058
- Acronym / sponsor ID
- CapPesq1252/07
- Conditions
- Arthritis, Rheumatoid, Spondylitis, Ankylosing
- Keywords
- Infliximab, Adalimumab, Etanercept, Heart failure, Diastolic disfunction, TNF blocker, Anti-TNF, Echocardiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (actual)
- First posted
- 19 Feb 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.
The purpose of this study is to determine possible alterations in cardiac function in patients with Rheumatoid Arthritis and Ankylosing Spondylitis under anti-TNF therapy, without clinical heart disfunction at baseline, using highly sensitive non-invasive methods.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNF blockers | Other | Drug: TNF blockers (infliximab, adalimumab, etanercept) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Rheumatoid Arthritis eligible to receive TNF blockers
- Diagnosis of Ankylosing Spondylitis eligible to receive TNF blockers
Key exclusion criteria (7 listed)
- Clinical heart failure
- Chagas'disease
- Stable or unstable angina
- Past history of myocardial infarct
- Systemic árterial hypertension (grade 3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNF blockers (infliximab, adalimumab, etanercept)Subjects enrolled, who were eligible to anti-TNF therapy, were evaluated by echocardiography (conventional and tissue doppler imaging)and biomarkers (NT-proBNP and troponin T)at baseline. Then, they were treated with adalimumab 40mg subcutaneously every 2 weeks or infliximab 3 or 5mg/Kg (0, 2 and 6 weeks and thereafter every 8 weeks)or etanercept 50mg subcutaneously every week. And they were re-evaluated with 6, 12, 18 and 24 months from first dose of the TNF blocker . | Drug | TNF blockers |
Primary outcome
Development, deterioration ou improvement of subclinical heart dysfunction
Time frame: 0, 6 ,12, 18 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
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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.
Eloisa S.D.O. Bonfá, MD, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TNF blockers (infliximab, adalimumab, etanercept) in people with Arthritis, Rheumatoid and Spondylitis, Ankylosing, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Development, deterioration ou improvement of subclinical heart dysfunction (time frame: 0, 6 ,12, 18 and 24 months). 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 7 Jun 2013.