dnaJ Peptide for Relieving Rheumatoid Arthritis - Tabular View

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dnaJ Peptide for Relieving Rheumatoid Arthritis

This study has been completed.

Study NCT00000435. Last updated on July 30, 2007. Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

dnaJ Peptide for Relieving Rheumatoid Arthritis

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 Measure ^†

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

Condition ^†

Rheumatoid Arthritis

Intervention ^†

Drug: dnaJ peptide
Drug: None-placebo

MEDLINE PMIDs

15024101

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

160

Start Date ^†

September 1999

Completion Date

September 2004

Eligibility 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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00000435

Organization ID

N01 AR92241

Secondary IDs ^††

NIAMS-042

Study Sponsor ^†

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

Collaborators ^††

Investigators ^†

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

First Received Date ^†

January 21, 2000

Last Updated Date

July 30, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.