Clinical Trials Logo
  1. Home
  2. Arthritis, Rheumatoid
  3. NCT01072058
  4. Details
NCT01072058 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01072058
Other study ID # CapPesq1252/07
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received February 18, 2010
Last updated June 5, 2013
Start date February 2008

Study information
Verified date June 2013
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

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 .

Locations
Country Name City State
Brazil Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development, deterioration ou improvement of subclinical heart dysfunction 0, 6 ,12, 18 and 24 months Yes
See also
  Status Clinical Trial Phase
Terminated NCT01682512 - Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis Phase 3
Completed NCT00539760 - A Phase I Rheumatoid Arthritis Study in Healthy Volunteers Phase 1
Active, not recruiting NCT03312465 - Anatomical Shoulder Domelock System Study
Completed NCT01208181 - A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107) Phase 3
Completed NCT03254810 - Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects Phase 1
Completed NCT01711814 - A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study Phase 2
Completed NCT03315494 - Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers Phase 1
Withdrawn NCT03241446 - Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA) Phase 1
Completed NCT02748785 - MTX Discontinuation and Vaccine Response Phase 4
Completed NCT02553018 - Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe Phase 3
Active, not recruiting NCT02260778 - Treat-to-target in RA: Collaboration To Improve adOption and adhereNce N/A
Completed NCT02569736 - Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation
Completed NCT01750931 - This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets. Phase 2
Not yet recruiting NCT01154647 - Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes N/A
Withdrawn NCT01204138 - Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA Phase 2
Completed NCT00913458 - Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis Phase 4
Completed NCT00973479 - An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy Phase 3
Completed NCT00975130 - Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) Phase 3
Completed NCT00550446 - A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis Phase 2
Completed NCT00660647 - Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA) Phase 3