Oral Collagen for Rheumatoid Arthritis

NCT ID: NCT00000401

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-07-31
• Study Completion Date: 2005-08-31

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 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.

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 levels of inflammation markers such as interferon gamma (IFN-gamma), interleukin-10 (IL-10), and transforming growth factor beta (TGF-beta). This study is a multicenter clinical trial to be conducted at the University of Tennessee, Memphis (the lead center) and the West Tennessee Medical Specialty Clinic (a collaborating site).

Patients enrolled will be allowed to continue a constant dose of disease-modifying anti-rheumatic drugs (DMARDs) and prednisone less than or equal to 7.5 mg/day. Patients will be randomly assigned to one of two groups. The low dose group will receive 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 90 mcg daily for 10 weeks, then 100 mcg daily for 10 weeks, followed by 130 mcg daily for 10 more weeks. Blood will be collected at screening and at Weeks 10, 20, and 30. Blood will be analyzed for indicators of inflammation.

Note: this trial is no longer being conducted as an intervention trial. Accrual has been discontinued, although patients previously enrolled are still being followed.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

Oral bovine type II collagen

Intervention Type: DRUG

Drug can be interrupted or stopped for suspected adverse events.

2

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.

Group Type: EXPERIMENTAL

Oral bovine type II collagen

Intervention Type: DRUG

Drug can be interrupted or stopped for suspected adverse events.

Interventions

Oral bovine type II collagen

Drug can be interrupted or stopped for suspected adverse events.

Intervention Type: DRUG

Other Intervention Names

CII

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

University of TN Health Science Center

Principal Investigators

Arnold E. Postlethwaite, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee at Memphis Department of Medicine

Locations

The Arthritis Clinic of Jackson, PLLC

Jackson, Tennessee, United States

University of Tennessee, Memphis

Memphis, Tennessee, United States

Countries

United States

References

Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. doi: 10.1007/s11926-001-0052-z.

Reference Type: BACKGROUND

PMID: 11177772 (View on PubMed)

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. doi: 10.1002/art.20361. No abstract available.

Reference Type: RESULT

PMID: 15334493 (View on PubMed)

Other Identifiers

R01AR045255

Identifier Type: NIH

Identifier Source: secondary_id

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NIAMS-037

Identifier Type: -

Identifier Source: secondary_id

R01AR045255

Identifier Type: NIH

Identifier Source: org_study_id

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