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

NCT02132234 | Unknown Phase 4

• 1 other identifier: UJ-KChWiMWsi-Reu
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in blood pressure

  Ambulatory Blood Pressure Monitoring (ABPM)

  prior to receiving anti-TNF-α treatment, 12 weeks

Secondary Outcomes (1)

• Change from baseline in endothelial function

  prior to receiving anti-TNF-α treatment, 12 weeks

Other Outcomes (1)

• Changes in immune cell subset populations from baseline

  prior to receiving anti-TNF-α treatment, 12 weeks

Study Arms (2)

Biological treatment

EXPERIMENTAL

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; Drug: Adalimumab; Drug: Certolizumab; Drug: Infliximab

control group

PLACEBO COMPARATOR

Patients with high disease activity receiving other than biological treatment and receiving placebo.

Interventions

Etanercept DRUG

biological treatment according to rheumatologic indication

Biological treatment

Adalimumab DRUG

biological treatment according to rheumatologic indication

Biological treatment

Certolizumab DRUG

biological treatment according to rheumatologic indication

Biological treatment

Infliximab DRUG

biological treatment according to rheumatologic indication

Biological treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead
• Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland: collaborator

Study Sites (1)

Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński

Krakow, Skarbowa 4, 31-121, Poland

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Hypertension

Interventions

Etanercept; Adalimumab; Certolizumab Pegol; Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments

Study Officials

• Tomasz Guzik, MD, PhD

  Jagiellonian University

  STUDY CHAIR

• Bogdan Batko, MD, PhD

  Department of Rheumatology, J. Dietl Hospital, Krakow, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 7, 2014
• Study Start: June 1, 2013
• Primary Completion: July 1, 2014
• Last Updated: May 7, 2014

Record last verified: 2014-05

Locations

PL (1)