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dnaJ Peptide for Relieving Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000435
Recruitment Status : Completed
First Posted : January 24, 2000
Last Update Posted : July 31, 2007
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: dnaJ peptide Drug: None-placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)
Study Start Date : September 1999
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: A
Subjects randomized to arm A received 25mg/day po of placebo
Drug: None-placebo
placebo was taken in pill form at 25mg/day for 6 months

Active Comparator: B
Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1
Drug: dnaJ peptide
dnaJP1 was taken in pill form at 25mg/day for 6 months

Primary Outcome Measures :
  1. 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 Frame: time points 112, 140 and 168 of the 6-month trial ]

Secondary Outcome Measures :
  1. Day 112 ACR 20 score [ Time Frame: Visit day 112 of the 6-month trial ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000435

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United States, Arizona
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5093
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Stanford University
Palo Alto, California, United States, 94305
United States, Colorado
Denver Arthritis Center
Denver, Colorado, United States, 80230
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Guthrie Clinic
Sayre, Pennsylvania, United States, 18840
United States, Washington
Virginia Mason Research Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: Salvatore Albani, MD University of California, San Diego
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00000435    
Other Study ID Numbers: N01 AR92241
First Posted: January 24, 2000    Key Record Dates
Last Update Posted: July 31, 2007
Last Verified: July 2007
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Immune Modulation
Oral Tolerance
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases