Search / Trial NCT00000401

Oral Collagen for Rheumatoid Arthritis

Launched by UNIVERSITY OF TENNESSEE · Nov 3, 1999

Apply for Trial

Trial Information

Current as of March 02, 2024

Completed

Keywords

Nsai Ds Oral Tolerance Drug Interaction Oral Administration Interleukin 10 Collagen Chemotherapy Human Therapy Evaluation Dmar Ds Ra Il 10

Description

RA is an inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints. The study will evaluate the effects of using oral bovine CII on RA patients by assessing the levels of inflammation markers such as interferon gamma (IFN-gamma), interleukin-10 (IL-10), and transforming growth factor beta (TGF-beta). This study is a multicenter clinical trial to be conducted at the University of Tennessee, Memphis (the lead center) and the West Tennessee Medical Specialty Clinic (a collaborating site). Patients enrolled will be allowed to continue a constant dose of dis...

Gender

All

Eligibility criteria

  • Note: accrual into this trial has been discontinued, but patients previously enrolled are still being followed.
  • Inclusion Criteria:
  • Clinically stable RA and unlikely to require adjustment of doses of DMARDs, NSAIDs, prednisone, or anti-TNFα therapies for the treatment phase of the study
  • Meets American College of Rheumatology (ACR) 1988 revised criteria for RA
  • Onset of disease at age 16 or older
  • Onset of disease at least 3 months prior to enrollment
  • PBMC - IFNγ - α1(II)/PBS stimulation index greater than or equal to 1.5 in 6 months prior to baseline visit
  • Agree to discontinue herbal remedies described in this protocol
  • Agree to use acceptable forms of contraception
  • Exclusion Criteria:
  • Participation in another clinical research study involving the evaluation of another investigational drug within 90 days prior to study entry
  • Currently taking greater than 7.5 mg prednisone daily
  • Intra-articular corticosteroid injections within 30 days prior to study entry
  • Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
  • Pregnancy
  • Beef allergy
  • Use of fish oil within 4 weeks of study entry
  • Previous use of auranofin or cyclophosphamide (all other DMARDs are allowed)
  • Previous autologous or heterologous stem cell transplantation
  • Active malignancy or past treatment consisting of antineoplastic drugs or total lymphoid irradiation
  • Intolerance to citrus juices or colorless carbonated beverages

Attachments

readout_NCT00000401_2024-03-02.pdf

4.5 MB

NCT00000401_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Jackson, Tennessee, United States

Memphis, Tennessee, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Before and after each 10-week treatment

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0