dnaJ Peptide for Relieving Rheumatoid Arthritis

July 30, 2007 updated by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724-5093
        • University of Arizona Health Sciences Center
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
      • Palo Alto, California, United States, 94305
        • Stanford University
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Center
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic
    • Washington
      • Seattle, Washington, United States, 98104
        • Virginia Mason Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Frame: time points 112, 140 and 168 of the 6-month trial
time points 112, 140 and 168 of the 6-month trial

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Salvatore Albani, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

January 21, 2000

First Submitted That Met QC Criteria

January 21, 2000

First Posted (Estimate)

January 24, 2000

Study Record Updates

Last Update Posted (Estimate)

July 31, 2007

Last Update Submitted That Met QC Criteria

July 30, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01 AR92241
  • NIAMS-042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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