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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02132234
• Other study ID #: UJ-KChWiMWsi-Reu
• Status: Recruiting
• Phase: Phase 4
• First received: April 28, 2014
• Last updated: May 5, 2014
• Start date: June 2013

Study information

• Verified date: May 2014
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Hypertension
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Etanercept
biological treatment according to rheumatologic indication
• Adalimumab
biological treatment according to rheumatologic indication
• Certolizumab
biological treatment according to rheumatologic indication
• Infliximab
biological treatment according to rheumatologic indication

Locations

Country	Name	City	State
Poland	Katedra Chorób Wewnetrznych i Medycyny Wsi, Uniwersytet Jagiellonski	Krakow, Skarbowa 4

Sponsors (2)

Lead Sponsor	Collaborator
Jagiellonian University	Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in immune cell subset populations from baseline	determination of subsets, activation markers, intracellular cytokine production	prior to receiving anti-TNF-a treatment, 12 weeks	Yes
Primary	Change from baseline in blood pressure	Ambulatory Blood Pressure Monitoring (ABPM)	prior to receiving anti-TNF-a treatment, 12 weeks	Yes
Secondary	Change from baseline in endothelial function	Flow Mediated Dilatation / Endo Pat	prior to receiving anti-TNF-a treatment, 12 weeks	Yes