Recruiting as of December, 2007
A Proof of Concept Trial of
Gleevec (Imatinib) in Active Diffuse Scleroderma
Study sponsor: Novartis Pharmaceuticals Canada Inc.
Coordinating center: Dr. Janet Pope Rheumatology Center St.
Joseph's Health Care London
Design: The purpose of this study is to investigate the
potential of Gleevec to be used as a novel therapy in the treatment
of scleroderma.
Inclusion criteria:
- Subjects must be able to give
informed consent.
- Subjects must meet preliminary
criteria for scleroderma.
- Subjects must have diffuse skin
involvement.
- Disease must appear to be active
as measured by worsening skin score and/or increased ESR.
- Serum SGOT <1.5 times upper
limit of normal.
- Bilirubin <1.5 times upper limit
of normal.
- AST/ALT <2.5 times upper limit
of normal
Exclusion criteria:
- Any past exposure to Gleevec
- Women of child bearing potential
must be practicing an acceptable form of contraception (OCP,
depo-provera, IUD, condoms with spermicidal or sterilization of
subject or partner)
- Women who are breastfeeding
- Certain abnormal labs
- Serious comorbidity that may
impair the ability to complete the study (severe heart disease,
severe pulmonary hypertension)
- Prednisone at doses of >10 mg/od
- Other potential disease
modifying drugs such as cyclophosphamide, mycophenylate and
methotrexate
- Serious liver disease -creatinine
>200
- Subjects taking endothelin
receptor blockers such as bosentan and sitaxsentan
- Alcohol consumption of >3 drinks
per week
Primary outcome measure:
Changes in profibrotic cytokine expression in serum and urine
samples and skin biopsies
Secondary outcome measures: Comparing secondary outcome
measurements such as: MD global, patient global, HAQ, SF36, Health
Transition, ESR, CRP
Completion: April 2009
Date of expected analysis: Analysis should be done in
December 2009
Return to
Current Studies