Clinical trial NCT02132234: Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Official title: Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Hypertension
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland
First posted: 2014-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in blood pressure
timeFrame: prior to receiving anti-TNF-α treatment, 12 weeks
Secondary outcomes:
measure: Change from baseline in endothelial function
timeFrame: prior to receiving anti-TNF-α treatment, 12 weeks
Other outcomes:
measure: Changes in immune cell subset populations from baseline
timeFrame: prior to receiving anti-TNF-α treatment, 12 weeks
Locations:
city: Krakow, Skarbowa 4
country: Poland
facility: Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński
Study officials:
affiliation: Jagiellonian University
name: Tomasz Guzik, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Rheumatology, J. Dietl Hospital, Krakow, Poland
name: Bogdan Batko, MD, PhD
role: STUDY_CHAIR
References: