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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02132234
• Date of registration: 28/04/2014
• Prospective Registration: No
• Primary sponsor: Jagiellonian University
• Public title: Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
• Scientific title: Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
• Date of first enrolment: June 2013
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02132234
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Poland

Contacts

• Name: Tomasz Guzik, MD, PhD
• Affiliation: Jagiellonian University

• Name: Bogdan Batko, MD, PhD

• Name: Bogdan Batko, MD, PhD
• Affiliation: Department of Rheumatology, J. Dietl Hospital, Krakow, Poland

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Hypertension

Rheumatoid Arthritis

Ankylosing Spondylitis

Intervention(s)

Drug: Certolizumab

Drug: Adalimumab

Drug: Etanercept

Drug: Infliximab

Primary Outcome(s)

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

Secondary Outcome(s)

Change from baseline in endothelial function [Time Frame: prior to receiving anti-TNF-a treatment, 12 weeks]

Secondary ID(s)

UJ-KChWiMWsi-Reu

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland