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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jagiellonian University
• Collaborator: Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland
• Treatments: Adalimumab; Certolizumab Pegol; Etanercept; Infliximab

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