Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
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ClinicalTrials.gov Identifier: NCT02132234 |
Recruitment Status : Unknown
Verified May 2014 by Tomasz Guzik, Jagiellonian University.
Recruitment status was: Recruiting
First Posted : May 7, 2014
Last Update Posted : May 7, 2014
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Condition or disease | Intervention/treatment | Phase |
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Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Hypertension | Drug: Etanercept Drug: Adalimumab Drug: Certolizumab Drug: Infliximab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis |
Study Start Date : | June 2013 |
Estimated Primary Completion Date : | July 2014 |

Arm | Intervention/treatment |
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Experimental: Biological treatment
Patients with high disease activity receiving biological treatment according to rheumatologic indication:
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Drug: Etanercept
biological treatment according to rheumatologic indication Drug: Adalimumab biological treatment according to rheumatologic indication Drug: Certolizumab biological treatment according to rheumatologic indication Drug: Infliximab biological treatment according to rheumatologic indication |
Placebo Comparator: control group
Patients with high disease activity receiving other than biological treatment and receiving placebo.
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- Change from baseline in blood pressure [ Time Frame: prior to receiving anti-TNF-α treatment, 12 weeks ]Ambulatory Blood Pressure Monitoring (ABPM)
- Change from baseline in endothelial function [ Time Frame: prior to receiving anti-TNF-α treatment, 12 weeks ]Flow Mediated Dilatation / Endo Pat
- Changes in immune cell subset populations from baseline [ Time Frame: prior to receiving anti-TNF-α treatment, 12 weeks ]determination of subsets, activation markers, intracellular cytokine production

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132234
Poland | |
Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński | Recruiting |
Krakow, Skarbowa 4, Poland, 31-121 | |
Contact: Bogdan Batko, MD, PhD 48126876261 | |
Contact: Agata Schramm, MD 48126876210 | |
Principal Investigator: Tomasz Guzik, MD, PhD | |
Principal Investigator: Bogdan Batko, MD, PhD | |
Principal Investigator: Agata Schramm, MD |
Study Chair: | Tomasz Guzik, MD, PhD | Jagiellonian University | |
Study Chair: | Bogdan Batko, MD, PhD | Department of Rheumatology, J. Dietl Hospital, Krakow, Poland |
Responsible Party: | Tomasz Guzik, MD, PhD, Jagiellonian University |
ClinicalTrials.gov Identifier: | NCT02132234 |
Other Study ID Numbers: |
UJ-KChWiMWsi-Reu |
First Posted: | May 7, 2014 Key Record Dates |
Last Update Posted: | May 7, 2014 |
Last Verified: | May 2014 |
Spondylitis Arthritis Arthritis, Rheumatoid Spondylarthritis Arthritis, Psoriatic Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infections Bone Diseases |
Spinal Diseases Spondylarthropathies Psoriasis Skin Diseases, Papulosquamous Skin Diseases Ankylosis Adalimumab Etanercept Infliximab Certolizumab Pegol Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Gastrointestinal Agents Anti-Inflammatory Agents, Non-Steroidal |