dnaJ Peptide for Relieving Rheumatoid Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

January 21, 2000

Last Updated Date

July 30, 2007

Start Date ^ICMJE

September 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000435 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

dnaJ Peptide for Relieving Rheumatoid Arthritis

Official Title ^ICMJE

A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: dnaJ peptide
Drug: None-placebo

Study Arms / Comparison Groups

Placebo Comparator: Subjects randomized to arm A received 25mg/day po of placebo
Active Comparator: Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

160

Completion Date

September 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000435

Responsible Party

Study ID Numbers ^ICMJE

N01 AR92241, NIAMS-042

Study Sponsor ^ICMJE

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Salvatore Albani, MD

University of California, San Diego

Information Provided By

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP