dnaJ Peptide for Relieving Rheumatoid Arthritis

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: None-placebo
Drug: dnaJ peptide

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000435
NIAMS-042
N01 AR92241

Details and patient eligibility

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.

Full 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.

Enrollment

160 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

160 participants in 2 patient groups, including a placebo group

A
Placebo Comparator group
Description:
Subjects randomized to arm A received 25mg/day po of placebo
Treatment:
Drug: None-placebo
B
Active Comparator group
Description:
Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1
Treatment:
Drug: dnaJ peptide

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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