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Home > "D" Clinical Trials Conditions > dnaJ Peptide for Relieving Rheumatoid Arthritis  dnaJ Peptide for Relieving Rheumatoid Arthritis
dnaJ Peptide for Relieving Rheumatoid Arthritis
For Condition: Rheumatoid Arthritis
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry 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 2x 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
Total Enrollment: 160
Location and Contact Information:
Overall Study Official:
SalvatoreAlbani, Principal Investigator, University of California, San Diego
Johns Hopkins University *Recruiting*
Baltimore, Maryland, 21224
United States
Recruiting Marilyn Towns 410-550-0579
University of California, Irvine Medical Center *Not yet recruiting*
Orange, California, 92868
United States
Not yet recruiting Irvine Center Trial Recruiter 714-456-7647
Mayo Clinic *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Jane Jaquith 507-284-4502
Guthrie Clinic *Recruiting*
Sayre, Pennsylvania, 18840
United States
Recruiting Karen Zombolas 570-882-6092
Stanford University *Recruiting*
Palo Alto, California, 94305
United States
Recruiting Cheryl Kallmann 650-723-8516
University of Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724-5093
United States
Recruiting Jo McClain 520-694-2319
Denver Arthritis Center *Not yet recruiting*
Denver, Colorado, 80230
United States
Not yet recruiting Janet Bird 303-394-2828
Virginia Mason Research Center *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Carey Edwards 206-223-6836
Additional Information:
Study ID Numbers: NIAMS-042; N01-AR-9-2241
Study Start Date: September 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000435
Other Rheumatoid Arthritis Studies:
1. Consistency of Traditional Chinese Medicine Diagnoses and Herbal Prescriptions for Rheumatoid Arthritis
2. Relaxation Response Training for the Treatment of Rheumatoid Arthritis
3. Efficacy & Safety of an Investigational Drug + Methotrexate Compared to Methotrexate Alone in Patients with Rheumatoid Arthritis
4. The Role of Cytokines on Growth Hormone Suppression in Premenopausal Women with Rheumatoid Arthritis and the Effect of Treatment with Etanercept
5. A Safety Study of Escalating Doses of PRO70769 for Subjects with Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate
Related Studies:
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dnaJ Peptide for Relieving Rheumatoid Arthritis
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