dnaJ Peptide for Relieving Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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 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