World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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:     Bogdan Batko, MD, PhD
Address: 
Telephone: 48126876261
Email:
Affiliation: 
Name:     Bogdan Batko, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Department of Rheumatology, J. Dietl Hospital, Krakow, Poland
Name:     Tomasz Guzik, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Jagiellonian University
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
Ankylosing Spondylitis
Hypertension
Psoriatic Arthritis
Rheumatoid Arthritis
Intervention(s)
Drug: Adalimumab
Drug: Certolizumab
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
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history