ong term follow up of patients with severe Systemic Sclerosis (SSc) and Rheumatoid Arthritis (RA) who have undergone Haematopoietic Stem Cell Transplantation (HSCT).
Phase 2
Recruiting
- Conditions
- Systemic Sclerosis and Rheumatoid ArthritisInflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12611000826943
- Lead Sponsor
- St Vincents Hospital, Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Patients who have undergone HSCT for severe Systemic Sclerosis and Rheumatoid Arthritis at St Vincents Hospital between 1996 and 2010.
Exclusion Criteria
Patients unwilling to sign consent forms and those who have a psychiatric condition preventing them from participating.
Severe end organ damage such as:
Left Ventricular Ejection Fraction <50%
DLCO/VA < 50%
Right Atrial pressure > 45mm Hg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and efficacy of HSCT. <br><br>Initial contact of telephone advising patients of centre which will invite them into study followed by letter with consent form, health assessment questionnaire and visual analogue scales. <br>The patients will be required to fill out a series of questionnaires to assess the impact of RA or SSc on their quality of life. <br> i. Health Assessment Questionnaire (HAQ)<br> ii. Visual Analogue Scales (VAS)<br> iii. Modified Rodnan Skin Score (For SSc patients only)<br>Subsequent to this, patients will be asked to come to Haematology outpatient to have their medical history taken and to answer questions related to the safety of past HSCT, particularly recurrence of their diseases, development of secondary tumour such as lymphoma, and risk of infection due to immunosuppressants.[Safety and efficacy of HSCT at 5 and 10 years post HSCT.]
- Secondary Outcome Measures
Name Time Method