A Phase 1/2 interventional study of Efalizumab in Autoimmune Diseases, sponsored by University of California, San Francisco. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-05-14.
Sponsored by University of California, San Francisco · Phase 1/2 and Interventional
The purpose of this pilot trial is to determine whether a conversion from calcineurin inhibitors (CNI) and mycophenolate mofetil (MMF) to a regimen consisting of efalizumab and sirolimus is associated with an increase in T regulatory cells, white cells that control the immune system and can prevent autoimmune diseases like arthritis or rejection of foreign organs,and does not result in an increase in acute rejection.
The objective of this pilot trial is to determine whether the conversion from calcineurin inhibitors (CNI) and mycophenolate mofetil (MMF) to efalizumab and sirolimus is associated with an increase in T regulatory cells and does not result in an increase in acute rejection following conversion. CNIs are associated with progressive nephrotoxicity, increased cardiovascular risk factor as well as an inhibitory effect on T regulatory cells.
PRIMARY OBJECTIVE:
To determine if the combination of efalizumab and sirolimus results in a significant increase in T regulatory cells. A hundred percent increase in T regulatory cells will be determined to be an important biologic effect of the combination of efalizumab and sirolimus.
SECONDARY OBJECTIVES:
To assess the feasibility of the conversion from CNI/MMF to efalizumab/sirolimus and to determine that this combination is safe and effective
To determine if there is an increase in FoxP3 mRNA in the urine of converted patients. Urine FoxP3 is believed to correlate with T regs in the kidney.
655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.
Browse Autoimmune Diseases studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Efalizumab will be started on Day 0 until the end of the study at Week 24. At the end of the first week, after efalizumab is started, cyclosporine or tacrolimus will be decreased by 50% and at 2 weeks the dose of cyclosporine or tacrolimus will be completely discontinued. At 12 weeks Cellcept or myfortic will be discontinued and the patient will be converted to sirolimus for the remainder of the study.
Drug: Efalizumab
1 mg/kg of efalizumab administered sub q once weekly
To determine if the combination of efalizumab and sirolimus results in a significant increase in T regulatory cells.
Time frame: Month 6
The successful conversion from CNI to non-CNI regimen without increasing the rejection rate by more than 20%.
Time frame: 6 Months
This study is withdrawn, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco