dnaJ Peptide for Relieving Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000435
• Other study ID #: N01AR92241
• Secondary ID: NIAMS-042
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2000
• Last updated: July 30, 2007
• Start date: September 1999
• Est. completion date: September 2004

Study information

• Verified date: July 2007
• Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Denver Arthritis Center	Denver	Colorado
United States	University of California, Irvine Medical Center	Orange	California
United States	Stanford University	Palo Alto	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Guthrie Clinic	Sayre	Pennsylvania
United States	Virginia Mason Research Center	Seattle	Washington
United States	University of Arizona Health Sciences Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 points 112, 140 and 168 of the 6-month trial
Secondary	Day 112 ACR 20 score		Visit day 112 of the 6-month trial