dnaJ Peptide for Relieving Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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 Title
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A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: dnaJ peptide
* Drug: None-placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Subjects randomized to arm A received 25mg/day po of placebo | Drug: None-placebo<br>* placebo was taken in pill form at 25mg/day for 6 months<br>|
| Active Comparator: B<br>Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1 | Drug: dnaJ peptide<br>* dnaJP1 was taken in pill form at 25mg/day for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day 112 ACR 20 score |  | Visit day 112 of the 6-month trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RA, Immune Modulation, Oral Tolerance, Peptide, dnaJ