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

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ClinicalTrials.gov Identifier: NCT02132234
Recruitment Status : Unknown
Verified May 2014 by Tomasz Guzik, Jagiellonian University.
Recruitment status was:  Recruiting
First Posted : May 7, 2014
Last Update Posted : May 7, 2014
Sponsor:
Collaborator:
Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland
Information provided by (Responsible Party):
Tomasz Guzik, Jagiellonian University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Hypertension Drug: Etanercept Drug: Adalimumab Drug: Certolizumab Drug: Infliximab Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Study Start Date : June 2013
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in blood pressure [ Time Frame: prior to receiving anti-TNF-α treatment, 12 weeks ]
    Ambulatory Blood Pressure Monitoring (ABPM)


Secondary Outcome Measures :
  1. Change from baseline in endothelial function [ Time Frame: prior to receiving anti-TNF-α treatment, 12 weeks ]
    Flow Mediated Dilatation / Endo Pat


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132234


Locations
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Poland
Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński Recruiting
Krakow, Skarbowa 4, Poland, 31-121
Contact: Bogdan Batko, MD, PhD    48126876261      
Contact: Agata Schramm, MD    48126876210      
Principal Investigator: Tomasz Guzik, MD, PhD         
Principal Investigator: Bogdan Batko, MD, PhD         
Principal Investigator: Agata Schramm, MD         
Sponsors and Collaborators
Jagiellonian University
Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland
Investigators
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Study Chair: Tomasz Guzik, MD, PhD Jagiellonian University
Study Chair: Bogdan Batko, MD, PhD Department of Rheumatology, J. Dietl Hospital, Krakow, Poland
More Information
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Responsible Party: Tomasz Guzik, MD, PhD, Jagiellonian University
ClinicalTrials.gov Identifier: NCT02132234    
Other Study ID Numbers: UJ-KChWiMWsi-Reu
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Rheumatoid
Spondylarthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infections
Bone Diseases
 Spinal Diseases
Spondylarthropathies
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis
Adalimumab
Etanercept
Infliximab
Certolizumab Pegol
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Anti-Inflammatory Agents, Non-Steroidal