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

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

Genetics Home Reference related topics: Ankylosing spondylitis Hypertension Psoriatic arthritis Rheumatoid arthritis

MedlinePlus related topics: Ankylosing Spondylitis Arthritis Psoriatic Arthritis Rheumatoid Arthritis

Genetic and Rare Diseases Information Center resources: Spondylarthropathy

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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:

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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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 History of Changes
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 Arthritis, Psoriatic Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Bone Diseases Spinal Diseases	Spondylarthropathies Spondylarthritis 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

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