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Clinical Trials/NL-OMON52909
NL-OMON52909
Recruiting
Phase 3

pfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial - UPSIDE study

niversitair Medisch Centrum Utrecht0 sites60 target enrollmentTBD
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Conditionsdiffuse cutaneous systemic sclerosisscleroderma10010761

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
diffuse cutaneous systemic sclerosis
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
60
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •1\. Age between 18 and 65 years.
  • •2\. Fulfilling the 2013 ACR\-EULAR classification criteria
  • •3\. Disease duration \<\= 2 years (from onset of first non\-Raynaud\*s symptoms) and
  • •\- mRSS \>\= 15 (diffuse skin pattern) and/or
  • •\- clinically significant organ involvement as defined by either:
  • •a) respiratory involvement
  • •b) renal involvement
  • •c) cardiac involvement

Exclusion Criteria

  • •1\. Pregnancy or unwillingness to use adequate contraception during study
  • •2\. Concomitant severe disease \=
  • •a) respiratory:
  • •\- pulmonary hypertension: a resting mean pulmonary artery pressure (mPAP) \>
  • •25 mmHg (by right heart catheterisation),
  • •\- DLCO \< 40% predicted or
  • •\- respiratory failure as defined by the primary endpoint (see 7\.1\)
  • •b) renal: creatinine clearance \< 40 ml/min (measured or estimated)
  • •c) cardiac: clinical evidence of refractory congestive heart failure; LVEF \<
  • •45% by cardiac echo or cardiac

Outcomes

Primary Outcomes

Not specified

Similar Trials

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CTIS2023-505877-34-00niversity Medical Center Utrecht88
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pfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized con-trolled trialSystemic Sclerosis
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Stem cell transplantation in diffuse cutaneous systemic sclerosis: upfront therapy or rescue therapy after failure of immunosuppressants?Diffuse cutaneous systemic sclerosis according to the ACR/EULAR criteriaTherapeutic area: Diseases [C] - Immune System Diseases [C20]
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