Rheumatoid Arthritis Clinical Trial
Official title:
Open Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid Arthritis
Verified date | May 2013 |
Source | University of Tennessee |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 joint damage and disability. This study will determine if oral bovine type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.
Status | Completed |
Enrollment | 110 |
Est. completion date | August 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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-TNFa 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 - IFN? - a1(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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Arthritis Clinic of Jackson, PLLC | Jackson | Tennessee |
United States | University of Tennessee, Memphis | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Carbone LD, McKown K, Pugazhenthi M, Barrow KD, Warrington K, Somes G, Postlethwaite AE. Dosage effects of orally administered bovine type I collagen on immune function in patients with systemic sclerosis. Arthritis Rheum. 2004 Aug;50(8):2713-5. — View Citation
Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Repeated measures analysis of variance with contrasts to determine if the change in the PBMC-IFN gamma-alpha 1(II)/PBS stimulation index is significantly at the 0.05 level and/or greater than or equal to 30%. | Before and after each 10-week treatment | No | |
Secondary | A Pearson correlation coefficient will be calculated for the change in the PBMC-INF gamma-alpha1(II)/PBS stimulation index and the change in the reactivity to RA CII epitope alpha 1 (II) CB11 for each dose. | Before and after each 10-week treatment | No |
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