Oral Collagen for Rheumatoid Arthritis

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00000401

Run by

University of Tennessee

People needed

110

Starts

1999-07-01

Expected to finish

2005-08-01

Last updated by the study team

2013-05-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Arthritis Clinic of Jackson, PLLC — Jackson, Tennessee, United States
• University of Tennessee, Memphis — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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