Oral Collagen for Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring NSAIDs, Oral Tolerance, Drug Interaction, Oral Administration, Interleukin 10, Collagen, Chemotherapy, Human Therapy Evaluation, DMARDs, RA, IL-10
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
Sites / Locations
- The Arthritis Clinic of Jackson, PLLC
- University of Tennessee, Memphis
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2
The low dose group will receive CII 30 mcg daily for 10 weeks, then 50 mcg daily for 10 weeks, followed by 70 mcg daily for 10 more weeks.
The high dose group will receive CII 90 mcg daily for 10 weeks, then 100 mcg daily for 10 weeks, followed by 130 mcg daily for 10 more weeks.