Completed

Phase 2
Age: 18Years - 85Years
All Genders
ID00000435

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

Led by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Updated on 2007-07-31

160

Participants Needed

8

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

dnaJ Peptide for Relieving Rheumatoid Arthritis

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

Trial Site Locations

Total: 8 locations

1

University of Arizona Health Sciences Center

Tucson, Arizona, United States, 85724-5093

Status Unknown

2

University of California, Irvine Medical Center

Orange, California, United States, 92868

Status Unknown

3

Stanford University

Palo Alto, California, United States, 94305

Status Unknown

4

Denver Arthritis Center

Denver, Colorado, United States, 80230

Status Unknown

5

Johns Hopkins University

Baltimore, Maryland, United States, 21224

Status Unknown

6

Mayo Clinic

Rochester, Minnesota, United States, 55905

Status Unknown

7

Guthrie Clinic

Sayre, Pennsylvania, United States, 18840

Status Unknown

8

Virginia Mason Research Center

Seattle, Washington, United States, 98104

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Epitope-specific immunotherapy of rheumatoid arthritis: clinical responsiveness occurs with immune deviation and relies on the expression of a cluster of molecules associated with T cell tolerance in a double-blind, placebo-controlled, pilot phase II trial.

Eva C Koffeman, Mark Genovese, Diane Amox...

https://pubmed.ncbi.nlm.nih.gov/19877047