Cardiovascular risk in patients with Ankylosing Spondylitis

Conditions: Ankylosing SpondylitisAtherosclerotic cardiovascular disease
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2013-002860-19-NL

Lead Sponsor: AMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Subjects with AS
?Age: =18 years
?Diagnosis of AS (following the 1984 Modified New York Criteria for ankylosing Spondylitis (16)) + disease duration since start of first symptoms for a period of more than 3 years.
?Subject agrees to the restrictions as described in paragraph 4.4.2. In brief: subjects are not permitted any alcohol or caffeine-containing food or drinks from 12 hrs prior to study visits until discharge. In addition, no strenuous exercise is permitted for 24 hrs before the study visits

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects may not enter this study if they meet the following criteria
?BMI > 30.
?History of diabetes mellitus/insulin use
?Hypertension/use of blood pressure lowering medication
?Smoking
?Use of statins prior to inclusion, or contra-indications for statin use.
?History of cardiovascular events
?Proven or suspected bacterial infections. Recent (<1 month prior to screening) or ongoing
?Serious infection requiring IV antibiotic therapy.
?Recent or current treatment with medications that may have a significant effect on plaque Inflammation as measured by plaque TBR, including but not limited to: Biological based medicines (anti-TNF (ex. Infliximab), anti-IL-6 therapy (ex. Tocilizumab) or anti-IL-1 (ex. anakinra)) within 8 weeks before the baseline visit and during the study.
?Any clinically significant medical condition that could interfere with the conduct of the study.
?Standard contra-indications to MRI, 18FDG PET, and CT, including pregnancy and lactating women.
?Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
?Subject has planned cardiac surgery, PCI or carotid stenting, or major non-cardiac surgery during the course of the study period or for 14 days after the last treatment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the anti-inflammatory effects of statin therapy on vessel wall inflammation by means of FDG PET/CT in AS patients<br>;Secondary Objective: ?To evaluate the change in vessel wall inflammation in AS over a follow up period of 3 years by means of FDG PET/CT.<br>?To determine the association between the systemic inflammation caused by AS and aorta and carotid wall inflammation in patients with AS, at baseline, after statin therapy intervention and at follow up period of three years. <br>;Primary end point(s): Main study parameter/endpoint <br>- change in Target-to-background ratio (TBR) in AS patients before and after statin therapy;Timepoint(s) of evaluation of this end point: At baseline, after 3 months of statin therapy and 1-2 years follow-up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary study parameters/endpoints<br>?AS disease duration <br>?Medical history, medication use, prior use of DMARD’s and biologicals <br>?Demographic parameters (age, race, gender) <br>?Blood pressure, heart rate, body weight <br>?Inflammatory parameters: CRP, hsCRP, BSE, IL1, Il6, TNF, IL17 <br>?Parameters of cardiovascular risk: Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, LP(a), blood pressure, and a spite tube for extra analyses. <br>?Changes in cellular inflammatory processes in whole blood by buffycoat isolation. <br>?Pre-existing (concurrent) conditions (those present at the screening visit) <br>?Vital signs (supine) and body temperature <br>;Timepoint(s) of evaluation of this end point: At baseline, after 3 months of statin therapy and 1-2 years follow-up