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Clinical Trials/EUCTR2005-001688-74-GB
EUCTR2005-001688-74-GB
Active, not recruiting
Phase 1

A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)

Guy's & St Thomas' NHS Foundation Trust0 sites70 target enrollmentAugust 16, 2005
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DrugsCellCept

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Guy's & St Thomas' NHS Foundation Trust
Enrollment
70
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 16, 2005
End Date
October 31, 2008
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Guy's & St Thomas' NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • •1\) Female SLE patients
  • •2\) Age 18\-50 years
  • •3\) Premenopausal using a reliable method of contraception
  • •4\) Clinically stable disease
  • •5\) Taking hydroxychloroquine and up to 15mgs of prednisolone daily
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •1\) Smokers
  • •2\) Pregnancy or breast feeding
  • •3\) Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)
  • •4\) Use of any investigational drug within 1 month prior to screening
  • •5\) Acute infections 2 weeks prior to Visit 1
  • •6\) History of ischaemic heart disease or end stage renal disease
  • •7\) Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease.

Outcomes

Primary Outcomes

Not specified

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