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

NCT01072058 | Unknown Phase 4

• 1 other identifier: CapPesq1252/07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing

Keywords

Infliximab; Adalimumab; Etanercept; Heart failure; Diastolic disfunction; TNF blocker; Anti-TNF; Echocardiography; Tissue doppler imaging; Brain Natriuretic Peptide; NT-proBNP

Outcome Measures

Primary Outcomes (1)

• Development, deterioration ou improvement of subclinical heart dysfunction

  0, 6 ,12, 18 and 24 months

Study Arms (1)

TNF blockers

OTHER

Drug: TNF blockers (infliximab, adalimumab, etanercept)

Interventions

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 .

TNF blockers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Rheumatoid Arthritis eligible to receive TNF blockers
• Diagnosis of Ankylosing Spondylitis eligible to receive TNF blockers

You may not qualify if:

• Clinical heart failure
• Chagas'disease
• Stable or unstable angina
• Past history of myocardial infarct
• Systemic árterial hypertension (grade 3)
• Valvulopathy
• Chronic kidney disease

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Heart Failure

Interventions

Tumor Necrosis Factor Inhibitors; Infliximab; Adalimumab; Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anti-Inflammatory Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Eloisa S.D.O. Bonfá, MD, PhD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: February 1, 2008
• Primary Completion: February 1, 2011
• Last Updated: June 7, 2013

Record last verified: 2013-06

Locations

BR (1)