Oral Collagen for Rheumatoid Arthritis - Full Text View

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00000401

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Oral bovine type II collagen	Phase II

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Repeated measures analysis of variance with contrasts to determine if the change in the PBMC-IFN gamma-alpha 1(II)/PBS stimlation index is significantly at the 0.05 level and/or greater than or equal to 30%. [ Time Frame: Before and after each 10-week treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Before and after each 10-week treatment ] [ Designated as safety issue: No ]

Enrollment:	110
Study Start Date:	July 1999
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: Oral bovine type II collagen Drug can be interrupted or stopped for suspected adverse events. Other Name: CII
Experimental: 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.	Drug: Oral bovine type II collagen Drug can be interrupted or stopped for suspected adverse events. Other Name: CII

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000401

Locations

United States, Tennessee
The Arthritis Clinic of Jackson, PLLC
Jackson, Tennessee, United States, 38301
University of Tennessee, Memphis
Memphis, Tennessee, United States, 38163

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Arnold E. Postlethwaite, MD

University of Tennessee at Memphis Department of Medicine

More Information

Publications:

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. No abstract available.

Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. Review.

Responsible Party:	Arnold E. Postlethwaite, MD, University of TN Health Science Center
ClinicalTrials.gov Identifier:	NCT00000401 History of Changes
Other Study ID Numbers:	R01 AR45255, NIAMS-037
Study First Received:	November 3, 1999
Last Updated:	March 5, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

NSAIDs
Oral Tolerance
Drug Interaction
Oral Administration
Interleukin 10
Collagen

Chemotherapy
Human Therapy Evaluation
DMARDs
RA
IL-10

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012