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Trial NCT00000435

Resource URI: http://static.linkedct.org/resource/trials/NCT00000435
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/31751>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/37675>
linkedct:brief_title dnaJ Peptide for Relieving Rheumatoid Arthritis
linkedct:condition <http://static.linkedct.org/resource/condition/11608>
linkedct: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
linkedct: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 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 85 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date September 2004
linkedct:enrollment 160 (xsd:int)
linkedct:firstreceived_date January 21, 2000
linkedct:id NCT00000435
linkedct:intervention <http://static.linkedct.org/resource/intervention/57841>
linkedct:intervention <http://static.linkedct.org/resource/intervention/61105>
rdfs:label Trial NCT00000435
linkedct:lastchanged_date July 30, 2007
linkedct:lead_sponsor_agency National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:location <http://static.linkedct.org/resource/location/159431>
linkedct:location <http://static.linkedct.org/resource/location/163294>
linkedct:location <http://static.linkedct.org/resource/location/190527>
linkedct:location <http://static.linkedct.org/resource/location/205793>
linkedct:location <http://static.linkedct.org/resource/location/208740>
linkedct:location <http://static.linkedct.org/resource/location/215187>
linkedct:location <http://static.linkedct.org/resource/location/216722>
linkedct:location <http://static.linkedct.org/resource/location/220017>
linkedct:nct_id NCT00000435
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)
linkedct:org_study_id N01 AR92241
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/52647>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00000435>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/74036>
linkedct:reference <http://static.linkedct.org/resource/reference/21475>
linkedct:secondary_id NIAMS-042
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/33885>
linkedct:source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:start_date September 1999
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date July 2007