Condition category
Musculoskeletal Diseases
Date applied
13/07/2005
Date assigned
07/09/2005
Last edited
24/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jill Belch

ORCID ID

Contact details

Division of Medicine and Therapeutics
Ninewell's Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632457
J.J.F.Belch@Dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Cardiovascular events and mortality in systemic sclerosis (SSc): a study of the effect of iloprost on these and on disease progression

Acronym

SSTEP: Systemic Sclerosis Trial of Events and Progression

Study hypothesis

That oral iloprost therapy is more effective than placebo in reducing SSc disease progression, and coronary and cerebrovascular events in patients with SSc.

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Systemic Sclerosis (SSc)

Intervention

Oral iloprost or placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Iloprost

Primary outcome measures

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 outcome measures

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

Overall trial start date

07/02/2002

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

215

Participant exclusion criteria

Excluded will be subjects with suspected serious physical illness such as cancer which may be expected to curtail life expectancy, psychiatric illness (reported by GP) and congenital heart disease. Exclusion will also be made of any patient who is pregnant or who wishes to bescome pregnant within the time course of the study.

Recruitment start date

07/02/2002

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Medicine and Therapeutics
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Research & Innovations Service
University of Dundee
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 344000
s.g.bell@dundee.ac.uk

Sponsor type

University/education

Website

http://www.dundee.ac.uk

Funders

Funder type

Charity

Funder name

The Raynauds and Scleroderma Association Charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/05/2016: No publications found, verifying study status with principal investigator