Phase IIA Study of the Safety and Tolerability of the Use of Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis
Further description of extension phase:
Patients will first be evaluated for inclusion in the extension phase of the study at either
the follow-up visit following three month withdrawal from Gleevec treatment or at the visit
after the follow-up visit. Patients can undergo evaluation for inclusion in the extension
phase up to six months following their completion of the initial one year trial. All
patients evaluated for inclusion in the extension phase will sign a new informed consent
form detailing the purpose and procedures associated with the extension phase at the initial
visit. After the initial visit, patients who meet inclusion criteria will be required to
undergo evaluation every three months for the 27 months following initiation of treatment,
or more frequently if deemed clinically necessary. Treatment will consist of Gleevec, at
doses ranging from 100 to 400 mg daily (100 mg pills will be distributed for oral
administration). At each study visit, a history and physical exam will be performed and
urine and blood tests will be conducted for disease activity and organ function. Additional
blood for research may also be collected at study visits. The Modified Rodnan Skin Score
will be measured to assess the degree of skin involvement associated with the patient's
disease. Patients will also continue to complete questionnaires about their ability to
function and quality of life.
Patients will be financially responsible for all professional and clinical services, as well
as all laboratory and diagnostic tests, associated with the extension phase of the study.
All co-pays, deductibles and co-insurances will be paid by the participants. Any additional
costs for parking and travel the patients incur as a result of participating in the
extension phase will not be reimbursed by the study. Novartis Pharmaceuticals will donate
drug supply.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of Gleevec in systemic sclerosis, as defined by an improvement in the Modified Rodnan skin score and indices of pulmonary function.
16 months for initial phase, 27 months for extension
Yes
Robert Spiera, MD
Principal Investigator
Hospital for Special Surgery, New York
United States: Institutional Review Board
27049
NCT00555581
August 2007
December 2013
Name | Location |
---|---|
Hospital for Special Surgery | New York, New York 10021 |