Upstate Active Clinical Trials Seeking Participants
Study title
Treatment of Systemic Lupus Erythematosous with N-acetylcysteine.
IRB number
5512
What is the purpose of the study?
The purpose of the first phase, Aim 1 is to establish the maximal dose that can be tolerated without side effects while raising GSH and improving mitochondrial biomarkers of T cell dysfunction. During the second phase, Aim 2, will determine the impact of an optimal NAC dose on disease activity and prednisone use in patients with SLE in a double blind placebo controlled 12-month study.
Who is eligible?
Age greater than 18yrs, male or female, SLE with greater than 4 of 11 diagnostic criteria approved by the American College of Rheumatology, clinically stable having SLEDAI scores 0-6 and no BILAG A or B scores, and stable medications (only 10 mg prednisone/day, nti-malarials, azathioprine or mycophenylate mofetil allowed as immunosuppressant medications for SLE. Healthy controls must be 18 yrs or older and matched SLE subjects by gender, age and ethnicity. They must not suffer from any chronic or infectious disease.
What is involved if I participate?
- How long is the study?
For Aim 1: 100 plus subjects: 50 SLE patients and 50 healthy controls. For Aim 2: 220 Subjects; 110 SLE subjects and 110 Healthy controls. Aim 1: 4 months (for SLE subjects); 1 year to complete study. Aim 2: 13 months (for SLE subjects); 4 years to complete study. - Is transportation provided or reimbursed?
Yes - Is parking provided or reimbursed?
Yes - What tests and procedures are involved?
At each visit up to 100ml. of blood will be drawn from each subject. 20ml. are needed for routine labs. and up to 90 ml. are needed for GSH/Immunological tests. There will be a total of 5 visits during the four months. The healthy control subjects will donate blood once at the screening visit.
Who is the doctor administering the study?
Andras Perl, MD.,Ph.D.
Where will the study take place?
UHCC (University Health Care Center) 90 Presidential Plaza, Syracuse, NY 13202
Rheumatology Research Lab. 8310 Weiskotten hall, SUNY Upstate Medical University, 750 East Adams St., Syracuse, NY 13210
Over what time period is the study scheduled to run?
Aim 2: 12/2009 thru 12/2013
Who can I contact for more information?
- Name: Rebecca Borsuk
- Phone: 315-464-2117
- Email: borsukr@upstate.edu
- Fax: 315-464-1947
If you are interested in this trial, please contact the study coordinator or investigator noted above.
