Nctid:
NCT00000435
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001168", "term"=>"Arthritis"}, {"id"=>"D000001172", "term"=>"Arthritis, Rheumatoid"}], "ancestors"=>[{"id"=>"D000007592", "term"=>"Joint Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000012216", "term"=>"Rheumatic Diseases"}, {"id"=>"D000003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M4476", "name"=>"Arthritis", "asFound"=>"Arthritis", "relevance"=>"HIGH"}, {"id"=>"M4480", "name"=>"Arthritis, Rheumatoid", "asFound"=>"Rheumatoid Arthritis", "relevance"=>"HIGH"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>160}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1999-09"}, "statusVerifiedDate"=>"2007-07", "completionDateStruct"=>{"date"=>"2004-09"}, "lastUpdateSubmitDate"=>"2007-07-30", "studyFirstSubmitDate"=>"2000-01-21", "studyFirstSubmitQcDate"=>"2000-01-21", "lastUpdatePostDateStruct"=>{"date"=>"2007-07-31", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2000-01-24", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"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", "timeFrame"=>"time points 112, 140 and 168 of the 6-month trial"}], "secondaryOutcomes"=>[{"measure"=>"Day 112 ACR 20 score", "timeFrame"=>"Visit day 112 of the 6-month trial"}]}, "conditionsModule"=>{"keywords"=>["RA", "Immune Modulation", "Oral Tolerance", "Peptide", "dnaJ"], "conditions"=>["Rheumatoid Arthritis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"15024101", "type"=>"BACKGROUND", "citation"=>"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. doi: 10.1073/pnas.0400061101. Epub 2004 Mar 15."}, {"pmid"=>"19877047", "type"=>"DERIVED", "citation"=>"Koffeman EC, Genovese M, Amox D, Keogh E, Santana E, Matteson EL, Kavanaugh A, Molitor JA, Schiff MH, Posever JO, Bathon JM, Kivitz AJ, Samodal R, Belardi F, Dennehey C, van den Broek T, van Wijk F, Zhang X, Zieseniss P, Le T, Prakken BA, Cutter GC, Albani S. Epitope-specific immunotherapy of rheumatoid arthritis: clinical responsiveness occurs with immune deviation and relies on the expression of a cluster of molecules associated with T cell tolerance in a double-blind, placebo-controlled, pilot phase II trial. Arthritis Rheum. 2009 Nov;60(11):3207-16. doi: 10.1002/art.24916."}]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"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.\n\nThis 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 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.\n* Diagnosis of rheumatoid arthritis of less than 5 years\n* Reactivity to dnaJ\n* Agree to use acceptable methods of contraception\n* Able to understand and sign informed consent\n\nExclusion Criteria:\n\n* 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)\n* Serum creatinine greater than 1.5 mg/dl\n* SGOT less than SGPT\n* Alkaline phosphatase greater than 2 times age/sex adjusted normal values\n* Hematocrit of less than 30\n* Platelets less than 130,000\n* History of lymphoma\n* Any active malignancy or cancer requiring treatment in the last 5 years, except for nonmelanoma skin cancers and carcinoma of the cervix in situ\n* Medical or psychiatric condition or active serious infection\n* Pregnant or breastfeeding"}, "identificationModule"=>{"nctId"=>"NCT00000435", "briefTitle"=>"dnaJ Peptide for Relieving Rheumatoid Arthritis", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)"}, "officialTitle"=>"A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)", "orgStudyIdInfo"=>{"id"=>"N01 AR92241"}, "secondaryIdInfos"=>[{"id"=>"NIAMS-042"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"A", "description"=>"Subjects randomized to arm A received 25mg/day po of placebo", "interventionNames"=>["Drug: None-placebo"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"B", "description"=>"Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1", "interventionNames"=>["Drug: dnaJ peptide"]}], "interventions"=>[{"name"=>"dnaJ peptide", "type"=>"DRUG", "description"=>"dnaJP1 was taken in pill form at 25mg/day for 6 months", "armGroupLabels"=>["B"]}, {"name"=>"None-placebo", "type"=>"DRUG", "description"=>"placebo was taken in pill form at 25mg/day for 6 months", "armGroupLabels"=>["A"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85724-5093", "city"=>"Tucson", "state"=>"Arizona", "country"=>"United States", "facility"=>"University of Arizona Health Sciences Center", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}, {"zip"=>"92868", "city"=>"Orange", "state"=>"California", "country"=>"United States", "facility"=>"University of California, Irvine Medical Center", "geoPoint"=>{"lat"=>33.78779, "lon"=>-117.85311}}, {"zip"=>"94305", "city"=>"Palo Alto", "state"=>"California", "country"=>"United States", "facility"=>"Stanford University", "geoPoint"=>{"lat"=>37.44188, "lon"=>-122.14302}}, {"zip"=>"80230", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Denver Arthritis Center", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"21224", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins University", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"55905", "city"=>"Rochester", "state"=>"Minnesota", "country"=>"United States", "facility"=>"Mayo Clinic", "geoPoint"=>{"lat"=>44.02163, "lon"=>-92.4699}}, {"zip"=>"18840", "city"=>"Sayre", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Guthrie Clinic", "geoPoint"=>{"lat"=>41.97896, "lon"=>-76.5155}}, {"zip"=>"98104", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Virginia Mason Research Center", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}], "overallOfficials"=>[{"name"=>"Salvatore Albani, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of California, San Diego"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "class"=>"NIH"}}}}
