Rheumatoid Arthritis Clinical Trial
Official title:
A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)
A small protein called dnaJ peptide may help people with rheumatoid arthritis (RA) by preventing their immune system cells from attacking their own tissues. The purpose of this study is to determine if small amounts of dnaJ peptide can "re-educate" immune cells in people with RA so that the cells stop attacking joint tissues.
Immune modulation is a promising new approach for the treatment of RA. Studies have shown
that immune cells in the joints of people in the early stages of RA react strongly against
dnaJ peptides from bacteria. These immune cells may also cross-react with human dnaJ
peptides in the joints to cause inflammation. dnaJ may help RA by "re-educating" the immune
system and dampening the abnormal inflammatory immune response in RA.
This study will last 7 months. Participants will be randomly assigned to receive either dnaJ
or placebo by mouth. At screening, participants will have medical history, physical, and
medication assessment. At screening, at 6 study visits every month after the start of
treatment, and at 1 month follow-up, participants will have a joint exam, blood and urine
collection, and will fill out a questionnaire about their condition.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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