Completed

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

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What is being tested

dnaJ peptide

+ None-placebo

Drug
Who is being recruted

Arthritis+6

+ Arthritis, Rheumatoid

+ Autoimmune Diseases

From 18 to 85 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: September 1999
See protocol details

Summary

Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1999

Actual date on which the first participant was enrolled.

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.

Official TitleA Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)
NCT00000435
Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue Diseases

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
10 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1

Group II

Placebo
Subjects randomized to arm A received 25mg/day po of placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

University of Arizona Health Sciences Center

Tucson, United StatesOpen University of Arizona Health Sciences Center in Google Maps
Suspended

University of California, Irvine Medical Center

Orange, United States
Suspended

Stanford University

Palo Alto, United States
Suspended

Denver Arthritis Center

Denver, United States
Completed8 Study Centers