Oral Collagen for Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Tennessee
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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