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dnaJ Peptide for Relieving Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dnaJ peptide
None-placebo
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA, Immune Modulation, Oral Tolerance, Peptide, dnaJ

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona Health Sciences Center
  • University of California, Irvine Medical Center
  • Stanford University
  • Denver Arthritis Center
  • Johns Hopkins University
  • Mayo Clinic
  • Guthrie Clinic
  • Virginia Mason Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Day 112 ACR 20 score

Full Information

First Posted
January 21, 2000
Last Updated
July 30, 2007
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00000435
Brief Title
dnaJ Peptide for Relieving Rheumatoid Arthritis
Official Title
A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
RA, Immune Modulation, Oral Tolerance, Peptide, dnaJ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to arm A received 25mg/day po of placebo
Arm Title
B
Arm Type
Active Comparator
Arm Description
Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1
Intervention Type
Drug
Intervention Name(s)
dnaJ peptide
Intervention Description
dnaJP1 was taken in pill form at 25mg/day for 6 months
Intervention Type
Drug
Intervention Name(s)
None-placebo
Intervention Description
placebo was taken in pill form at 25mg/day for 6 months
Primary Outcome Measure Information:
Title
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 Information:
Title
Day 112 ACR 20 score
Time Frame
Visit day 112 of the 6-month trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Albani, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5093
Country
United States
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Denver Arthritis Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Guthrie Clinic
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15024101
Citation
Prakken BJ, Samodal R, Le TD, Giannoni F, Yung GP, Scavulli J, Amox D, Roord S, de Kleer I, Bonnin D, Lanza P, Berry C, Massa M, Billetta R, Albani S. Epitope-specific immunotherapy induces immune deviation of proinflammatory T cells in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2004 Mar 23;101(12):4228-33. doi: 10.1073/pnas.0400061101. Epub 2004 Mar 15.
Results Reference
background
PubMed Identifier
19877047
Citation
Koffeman EC, Genovese M, Amox D, Keogh E, Santana E, Matteson EL, Kavanaugh A, Molitor JA, Schiff MH, Posever JO, Bathon JM, Kivitz AJ, Samodal R, Belardi F, Dennehey C, van den Broek T, van Wijk F, Zhang X, Zieseniss P, Le T, Prakken BA, Cutter GC, Albani S. 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. Arthritis Rheum. 2009 Nov;60(11):3207-16. doi: 10.1002/art.24916.
Results Reference
derived

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dnaJ Peptide for Relieving Rheumatoid Arthritis

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