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

May 5, 2014 updated by: Tomasz Guzik, Jagiellonian University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Krakow, Skarbowa 4, Poland, 31-121
        • Recruiting
        • Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński
        • Contact:
          • Bogdan Batko, MD, PhD
          • Phone Number: 48126876261
        • Contact:
          • Agata Schramm, MD
          • Phone Number: 48126876210
        • Principal Investigator:
          • Tomasz Guzik, MD, PhD
        • Principal Investigator:
          • Bogdan Batko, MD, PhD
        • Principal Investigator:
          • Agata Schramm, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

For patients suffering from rheumatoid arthritis:

  • rheumatoid arthritis diagnosed based on The American Rheumatism Association Criteria from 1987
  • ineffective treatment with 2 disease-modifying antirheumatic drugs (DMARDs) for 6 months each, including treatment with maximal doses of methotrexate for at least 3 months (or intolerance to treatment)
  • high disease activity - Disease Activity Score 28 (DAS 28) > 5,1 measured twice, with a 1-month interval
  • for patients with mainly lower limbs affected with DAS 28 > 3,7

For patients suffering from Ankylosing Spondylitis:

  • Ankylosing Spondylitis diagnosed based on Modified New York Criteria
  • ineffective treatment with 2 non-steroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months
  • high disease activity -Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > 4 measured twice, with a 12-week interval
  • spinal pain > 4cm on 10cm Visual Analogue Scale (VAS) measured twice, with a 12-week interval
  • general disease activity assessment > 5 (0-10 scale) performed after the 2nd VAS and BASDAI assessment

For patients suffering from Psoriatic Arthritis:

- Psoriatic arthritis diagnosed based on the Bennett or Classification Criteria for Psoriatic Arthritis (CASPAR Criteria)

If peripheral joints are affected:

active disease assessed twice, with a 4-week interval on stable treatment, after 2 DMARDs treatment for at least 4 months

Criteria of active disease (all have to be met):

  • At least 5 out of 66 joints swollen - assessed twice, with a 4-week interval
  • At least 5 out of 68 joints tender - assessed twice, with a 4-week interval
  • general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by patient
  • general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by physician
  • general disease activity assessment > 5 (0-10 scale) performed after 2nd assessment of number of tender and swollen joints

If axial joints are affected:

  • Sacroiliac joints affected according to the New York Criteria of Ankylosing Spondylitis
  • Active and severe disease assessed twice, with a 12-week interval, stable treatment, ineffective treatment with 2 nonsteroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months each

Criteria of active disease (all must be present):

  • BASDAI > 4 measured twice, with a 12-week interval
  • spinal pain > 4cm on 10 cm in the VAS measured twice, with a 12-week interval
  • general disease activity assessment > 5 (0-10 scale) Patients can take steroid in stable dose within one month - maximal dose 10mg/day of prednisone.

Exclusion Criteria:

  • non-consenting patient
  • pregnancy
  • breast-feeding
  • allergy for the drug or any component
  • cardiac insufficiency (NYHA III or IV)
  • active infection
  • infection within the last 3 months: hepatitis, pneumonia, pyelonephritis
  • opportunistic infection within the last 2 months: active infection of cytomegalovirus, Pneumocystis carinii
  • joint infection within the last 12 months
  • endoprosthesis infection within the last 12 months or any time if the joint was not replaced
  • exacerbation of lung-, kidney-, liver- or heart insufficiency during treatment
  • demyelinating disease or its symptoms
  • pancytopenia or aplastic anemia
  • pre-cancer stage
  • neoplasm within the last 5 years including solid tumors and neoplasm of haematopoietic or lymphatic system with risk of recurrence or progression
  • active alcoholic disease
  • chronic liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Etanercept
biological treatment according to rheumatologic indication
Drug: Adalimumab
biological treatment according to rheumatologic indication
Drug: Certolizumab
biological treatment according to rheumatologic indication
Drug: Infliximab
biological treatment according to rheumatologic indication
Placebo Comparator: control group
Patients with high disease activity receiving other than biological treatment and receiving placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in blood pressure
Time Frame: prior to receiving anti-TNF-α treatment, 12 weeks
Ambulatory Blood Pressure Monitoring (ABPM)
prior to receiving anti-TNF-α treatment, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in endothelial function
Time Frame: prior to receiving anti-TNF-α treatment, 12 weeks
Flow Mediated Dilatation / Endo Pat
prior to receiving anti-TNF-α treatment, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in immune cell subset populations from baseline
Time Frame: prior to receiving anti-TNF-α treatment, 12 weeks
determination of subsets, activation markers, intracellular cytokine production
prior to receiving anti-TNF-α treatment, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Collaborators

Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland

Investigators

  • Study Chair: Tomasz Guzik, MD, PhD, Jagiellonian University
  • Study Chair: Bogdan Batko, MD, PhD, Department of Rheumatology, J. Dietl Hospital, Krakow, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UJ-KChWiMWsi-Reu

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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