dnaJ Peptide for Relieving Rheumatoid Arthritis

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Rheumatoid Arthritis

Interventions

dnaJ peptideDRUG

dnaJP1 was taken in pill form at 25mg/day for 6 months

None-placeboDRUG

placebo was taken in pill form at 25mg/day for 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (8)

University of Arizona Health Sciences Center

Tucson, Arizona, United States

University of California, Irvine Medical Center

Orange, California, United States

Stanford University

Palo Alto, California, United States

Denver Arthritis Center

Denver, Colorado, United States

Outcomes

Primary Outcomes

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 frame: time points 112, 140 and 168 of the 6-month trial

Secondary Outcomes

Day 112 ACR 20 score

Time frame: Visit day 112 of the 6-month trial

Data from ClinicalTrials.gov

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