NCT00000435

dnaJ Peptide for Relieving Rheumatoid Arthritis

A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NIH
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	dnaJ peptide	dnaJP1 was taken in pill form at 25mg/day for 6 months
DRUG	None-placebo	placebo was taken in pill form at 25mg/day for 6 months

Timeline

• Start date: 1999-09-01
• Completion: 2004-09-01
• First posted: 2000-01-24
• Last updated: 2007-07-31

Locations

8 sites across 1 country: United States