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.

Official Title

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

Conditions

– Rheumatoid Arthritis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

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.

Study Start

Eligibility & Criteria

Ages Eligible for Study: 18 Years – 85 Years, Genders Eligible for Study: Both Criteria 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 2x 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

Total Enrolment

160

Contact Details

[1] National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)