dnaJ Peptide for Relieving Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00000435

Run by

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

People needed

160

Starts

1999-09-01

Expected to finish

2004-09-01

Last updated by the study team

2007-07-31

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Johns Hopkins University — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Guthrie Clinic — Sayre, Pennsylvania, United States
• Virginia Mason Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.