dnaJ Peptide for Relieving Rheumatoid Arthritis - Full Text View

Sponsored by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00000435

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: dnaJ peptide Drug: None-placebo	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

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:

Day 112 ACR 20 score [ Time Frame: Visit day 112 of the 6-month trial ]

Enrollment:	160
Study Start Date:	September 1999
Estimated Study Completion Date:	September 2004

Arms	Assigned Interventions
A: Placebo Comparator 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
B: Active Comparator 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000435

Locations

United States, Arizona
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5093
United States, California
Stanford University
Palo Alto, California, United States, 94305
University of California, Irvine Medical Center
Orange, California, United States, 92868
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)

Investigators

Principal Investigator:

Salvatore Albani, MD

University of California, San Diego

More Information

Publications:

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. Epub 2004 Mar 15.

Study ID Numbers:	N01 AR92241, NIAMS-042
Study First Received:	January 21, 2000
Last Updated:	July 30, 2007
ClinicalTrials.gov Identifier:	NCT00000435
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

RA
Immune Modulation
Oral Tolerance
Peptide
dnaJ

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009