The primary objective of this study is to describe the effect of HSCT on the microangiopathy of SSc patients by using nailfold capillary microscopy (NCM). The secondary objective is to investigate the correlation between NCM findings and clinical…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Microangiopathy will be assessed by NCM. NCM pattern will be classified as
early, active or late. Capillary density, number of giants and number of
micro-haemorrhages will be observed. Additionally, PRINCE, MES scores and mNEMO
scores will be calculated.
Secondary outcome
To assess clinical response, a physician global assessment for treatment
response will be performed per organ system, the Medsger SSc severity score
will be assessed, and the HAQ-DI will be calculated.
Background summary
The results of clinical trials evaluating the effect of autologous HSCT in SSc
were encouraging. However, treatment related mortality is high and not all
patients benefit from HSCT. Therefore, more research is needed to understand
the biological effect of autologous HSCT on SSc. Uncontrolled case series
indicate reversibility of microangiopathy after autologous HSCT.
Study objective
The primary objective of this study is to describe the effect of HSCT on the
microangiopathy of SSc patients by using nailfold capillary microscopy (NCM).
The secondary objective is to investigate the correlation between NCM findings
and clinical response.
Study design
Prospective nested case-control study
Study burden and risks
Participants will be invited to visit the hospital once for an NCM procedure
which is not invasive or painful and takes approximately 15-30 minutes. When
auto-antibody status is not determined within the last 12 months before the
current visit, additionally a serum sample will be obtained. Relevant
demographic and clinical information are collected from the biobank Systemic
sclerosis database. No risks are associated with the participation in this
study.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1. Age above 18
2. Systemic sclerosis meeting the American Rheumatism Association criteria (1980)
3. Severe systemic sclerosis with:
a. disease duration < 4 years with modified Rodnan skin score >15 and respiratory involvement
b. disease duration < 2 years with modified Rodnan skin score >20 and ESR > 25 mm/1st hour and/or Hb < 11 g/dL
4. Written informed consent
5. Able and willing to perform additional nailfold capillaromicroscopy at the outpatient clinic of the LUMC
Exclusion criteria
none
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59376.058.16 |