Status:
COMPLETED
dnaJ Peptide for Relieving Rheumatoid Arthritis
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 i...
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 ...
Eligibility 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
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00000435
Start Date
September 1 1999
End Date
September 1 2004
Last Update
July 31 2007
Active Locations (8)
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1
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5093
2
University of California, Irvine Medical Center
Orange, California, United States, 92868
3
Stanford University
Palo Alto, California, United States, 94305
4
Denver Arthritis Center
Denver, Colorado, United States, 80230