Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker
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ClinicalTrials.gov Identifier: NCT01072058 |
Recruitment Status : Unknown
Verified June 2013 by Julio Moraes, MD, University of Sao Paulo.
Recruitment status was: Active, not recruiting
First Posted : February 19, 2010
Last Update Posted : June 7, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arthritis, Rheumatoid Spondylitis, Ankylosing | Drug: TNF blockers (infliximab, adalimumab, etanercept) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
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 |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | February 2011 |

Arm | Intervention/treatment |
---|---|
TNF blockers |
Drug: 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 . |
- Development, deterioration ou improvement of subclinical heart dysfunction [ Time Frame: 0, 6 ,12, 18 and 24 months ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Rheumatoid Arthritis eligible to receive TNF blockers
- Diagnosis of Ankylosing Spondylitis eligible to receive TNF blockers
Exclusion Criteria:
- Clinical heart failure
- Chagas'disease
- Stable or unstable angina
- Past history of myocardial infarct
- Systemic árterial hypertension (grade 3)
- Valvulopathy
- Chronic kidney disease

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): NCT01072058
Brazil | |
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo | |
Sao Paulo, Brazil |
Study Director: | Eloisa S.D.O. Bonfá, MD, PhD |
Responsible Party: | Julio Moraes, MD, MD, University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT01072058 |
Other Study ID Numbers: |
CapPesq1252/07 |
First Posted: | February 19, 2010 Key Record Dates |
Last Update Posted: | June 7, 2013 |
Last Verified: | June 2013 |
Infliximab Adalimumab Etanercept Heart failure Diastolic disfunction TNF blocker |
Anti-TNF Echocardiography Tissue doppler imaging Brain Natriuretic Peptide NT-proBNP |
Spondylitis Arthritis Arthritis, Rheumatoid Spondylarthritis Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infections Bone Diseases Spinal Diseases |
Spondylarthropathies Ankylosis Adalimumab Etanercept Tumor Necrosis Factor Inhibitors Infliximab Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Gastrointestinal Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |