Status:
COMPLETED
Oral Collagen for Rheumatoid Arthritis
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation of the joints. In RA, the immune system attacks a person's own cells inside joints, eventually leading to ...
Detailed 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 le...
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
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00000401
Start Date
July 1 1999
End Date
August 1 2005
Last Update
May 29 2013
Active Locations (2)
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1
The Arthritis Clinic of Jackson, PLLC
Jackson, Tennessee, United States, 38301
2
University of Tennessee, Memphis
Memphis, Tennessee, United States, 38163