Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Sponsor
Jagiellonian University
Study ID
NCT02132234
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etanercept — DRUG
    biological treatment according to rheumatologic indication
  • Adalimumab — DRUG
    biological treatment according to rheumatologic indication
  • Certolizumab — DRUG
    biological treatment according to rheumatologic indication
  • Infliximab — DRUG
    biological treatment according to rheumatologic indication

Study Details

The aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha (TNF-α) treatment on blood pressure, endothelial function and immune cell phenotype in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Key Dates

Start date
Jun 30, 2013
Status verified
May 2014
Primary completion
Jul 31, 2014

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Biological treatment
    Patients with high disease activity receiving biological treatment according to rheumatologic indication: * etanercept 50 mg s.c. every week * adalimumab 40 mg s.c. every 2 weeks * certolizumab 400 mg s.c. every 2 weeks for 4 weeks, then 200mg every 2 weeks * infliximab 3 or 5 mg/kg i.v. 2 and 6 weeks from the first admission, then every 8 weeks
  • Placebo Comparator: control group
    Patients with high disease activity receiving other than biological treatment and receiving placebo.

Primary Outcome Measure

Change from baseline in blood pressure [ Time Frame: prior to receiving anti-TNF-α treatment, 12 weeks ]

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