Trial record 13 of 1518 for:    TNF

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Julio Moraes, MD, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01072058
First received: February 18, 2010
Last updated: June 5, 2013
Last verified: June 2013
  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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Eloisa S.D.O. Bonfá, MD, PhD
  More Information

No publications provided

Responsible Party: Julio Moraes, MD, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01072058     History of Changes
Other Study ID Numbers: CapPesq1252/07
Study First Received: February 18, 2010
Last Updated: June 5, 2013
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
Ankylosis
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Adalimumab
Infliximab
Natriuretic Peptide, Brain
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on October 23, 2014