Text Size
Trial record 10 of 1259 for:    TNF
Previous Study | Return to List | Next Study

Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01072058
First received: February 18, 2010
Last updated: February 23, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Arthritis, Rheumatoid
Spondylitis, Ankylosing
 Drug: TNF blockers (infliximab, adalimumab, etanercept)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Development, deterioration ou improvement of subclinical heart dysfunction [ Time Frame: 0, 6 ,12, 18 and 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 .

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072058

Contacts
Contact: Jozélio F Carvalho, MD, PhD 55-11-30617490 jotafc@gmail.com
Contact: Julio Cesar B Moraes, MD 55-11-30617490 reumato@usp.br

Locations
Brazil
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo Recruiting
Sao Paulo, Brazil
Contact: Jozelio F Carvalho, MD, PhD            
Principal Investigator: Jozelio F Carvalho, MD, PhD            
Sub-Investigator: Julio Cesar B Moraes, MD            
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Eloisa S.D.O. Bonfá, MD, PhD
  More Information

No publications provided

Responsible Party: Prof. Eloisa Bonfa/ Full Professor, Rheumatology Division of Faculdade de Medicina da Universidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT01072058     History of Changes
Other Study ID Numbers: CapPesq1252/07
Study First Received: February 18, 2010
Last Updated: February 23, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
TNF blocker
Anti-TNF
Infliximab
Adalimumab
Etanercept
Heart failure
 Diastolic disfunction
Echocardiography
Tissue doppler imaging
Brain Natriuretic Peptide
NT-proBNP

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
 Spondylarthritis
Ankylosis
Natriuretic Peptide, Brain
TNFR-Fc fusion protein
Infliximab
Adalimumab
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on May 19, 2013