Systemic sclerosis (SSc) Musculoskeletal Diseases Systemic sclerosis
Conditions
Interventions
Oral iloprost or placebo
Added 11/08/2017:
The study was a randomised, placebo-controlled clinical trial with a one month placebo run in to ensure patients were compli
at six months
and then six monthly until their final visit at the end of the study period. Block randomisation was done for each site in blocks of six (three active versus three placebo) to ensure even distribution
Sponsors
University of Dundee (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be patients with both limited and diffuse SSc, as our pilot work has shown atherosclerotic vascular disease to occur in both groups. The patients considered for this study will be as follows: 1. Any patient fulfilling Arthritis Research Campaign (ARC) criteria for SSc 2. Any patient with Raynaud?s Phenomenon and at least 3 other features of limited SSc 3. Any patient with Raynaud?s Phenomenon and the presence of an SSc-related autoantibody (e.g. anticentromere, antitopo1 [scleroderma 70], anti-U1RNP, anti-ThRNP, anti-U3RNP, anti-PmScl) All will be >40 years of age. These patients will be recruited from Connective Tissue Disease clinics throughout Tayside, Fife, Strathclyde, Lothian, Grampian, Yorkshire, Bath, Northamptonshire and Ireland. Patients with SSc will be invited to attend the clinics to have their vascular risk factors assessed. Volunteers will then be asked to give informed consent and if that consent is given, enter the screening phase of the study
Exclusion criteria
Exclusion criteria: 1. Suspected serious physical illness such as cancer which may be expected to curtail life expectancy 2. Psychiatric illness (reported by GP) 3. Congenital heart disease 4. Any patient who is pregnant or who wishes to become pregnant within the time course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite primary endpoint is sought for this study. 1. Fatal coronary and stroke events plus non fatal myocardial infarction and stroke 2. Vascular disease death 3. SSc disease progression to include: 3.1. Deteriorating renal function as measured by 24-hour urine and blood sampling for creatinine clearance 3.2. Deteriorating lung function as measured by changes in DLCO total lung capacity 3.3. Increase in pulmonary artery pressure measured in millimetres in mercury by echocardiogram 3.4. Skin score assessed using the modified Rodnan Skin Score These will be monitored and percentage change from baseline calculated. If deterioration is indicated by an increasing figure then 30% change will be required. If deterioration is based on a decreasing number then 20% change from baseline will be required. Additionally the Medsger categories will be evaluated. A final decision regarding the primary endpoints will be carried out by the Data and Safety Monitoring Committee approximately 8 months into the study. The definition of the above cardiovascular (CV) events will be made according to the World Health Organisation (WHO) Criteria for the diagnosis of coronary events and stroke (fatal and non-fatal). | — |
Secondary
| Measure | Time frame |
|---|---|
| The main secondary endpoints are: 1. All cause mortality 2. Non-fatal myocardial infarction and stroke 3. Occurrence of other vascular events including requirement of coronary or peripheral arterial bypass surgery and/or angioplasty, development of angina, claudication or development of critical limb ischaemia 4. Severity of Raynaud'?s Phenomenon | — |
Countries
Ireland, United Kingdom
Outcome results
None listed