Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
160 participants
INTERVENTIONAL
1999-09-30
2004-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Subjects randomized to arm A received 25mg/day po of placebo
None-placebo
placebo was taken in pill form at 25mg/day for 6 months
B
Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1
dnaJ peptide
dnaJP1 was taken in pill form at 25mg/day for 6 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dnaJ peptide
dnaJP1 was taken in pill form at 25mg/day for 6 months
None-placebo
placebo was taken in pill form at 25mg/day for 6 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Salvatore Albani, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arizona Health Sciences Center
Tucson, Arizona, United States
University of California, Irvine Medical Center
Orange, California, United States
Stanford University
Palo Alto, California, United States
Denver Arthritis Center
Denver, Colorado, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Guthrie Clinic
Sayre, Pennsylvania, United States
Virginia Mason Research Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIAMS-042
Identifier Type: -
Identifier Source: secondary_id
N01 AR92241
Identifier Type: -
Identifier Source: org_study_id