Rheumatoid Arthritis Clinical Trial
Official title:
A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | September 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Denver Arthritis Center | Denver | Colorado |
United States | University of California, Irvine Medical Center | Orange | California |
United States | Stanford University | Palo Alto | California |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Guthrie Clinic | Sayre | Pennsylvania |
United States | Virginia Mason Research Center | Seattle | Washington |
United States | University of Arizona Health Sciences Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Prakken BJ, Samodal R, Le TD, Giannoni F, Yung GP, Scavulli J, Amox D, Roord S, de Kleer I, Bonnin D, Lanza P, Berry C, Massa M, Billetta R, Albani S. Epitope-specific immunotherapy induces immune deviation of proinflammatory T cells in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2004 Mar 23;101(12):4228-33. Epub 2004 Mar 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 points 112, 140 and 168 of the 6-month trial | ||
Secondary | Day 112 ACR 20 score | Visit day 112 of the 6-month trial |
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