Rheumatoid Arthritis
Conditions
Keywords
RA, Immune Modulation, Oral Tolerance, Peptide, dnaJ
Brief 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.
Interventions
DRUGdnaJ peptide
dnaJP1 was taken in pill form at 25mg/day for 6 months
DRUGNone-placebo
placebo was taken in pill form at 25mg/day for 6 months
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Active rheumatoid arthritis as defined by the revised American College of Rheumatology (ACR) 1987 criteria. Evidence of active disease will be based on at least six swollen or nine tender joints. * Diagnosis of rheumatoid arthritis of less than 5 years * Reactivity to dnaJ * Agree to use acceptable methods of contraception * Able to understand and sign informed consent
Exclusion criteria
* Patients taking more 7.5 mg of prednisone or disease modifying agents other than hydrochloroquine or sulfasalazine (i.e., gold, penicillamine, azathioprine, cyclophosphamide, methotrexate, cyclosporine, or anti-TNF agents) * Serum creatinine greater than 1.5 mg/dl * SGOT less than SGPT * Alkaline phosphatase greater than 2 times age/sex adjusted normal values * Hematocrit of less than 30 * Platelets less than 130,000 * History of lymphoma * Any active malignancy or cancer requiring treatment in the last 5 years, except for nonmelanoma skin cancers and carcinoma of the cervix in situ * Medical or psychiatric condition or active serious infection * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve or 'AUC' obtained by adding 0 for no response and 1 for an ACR 20 response for visits on Day 112, 140, and 168 | time points 112, 140 and 168 of the 6-month trial |
Secondary
| Measure | Time frame |
|---|---|
| Day 112 ACR 20 score | Visit day 112 of the 6-month trial |
Countries
United States
Outcome results
None listed