NCT00000401|CompletedPhase 2DMC
Oral Collagen for Rheumatoid Arthritis
Open Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid Arthritis
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Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
110
1 country
2
Study Start
July 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2005
Actual (reported)Study Completion
August 2005
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1999
Date type not reportedThis date has not been verified as actual or estimated.
November 3, 1999
Actual (reported)November 4, 1999
Actual (reported)August 2005
Actual (reported)August 2005
Actual (reported)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
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
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.
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 can be interrupted or stopped for suspected adverse events.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Arthritis Clinic of Jackson, PLLC
Jackson, Tennessee, 38301, United States
University of Tennessee, Memphis
Memphis, Tennessee, 38163, United States
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.
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.
Arnold E. Postlethwaite, MD
University of Tennessee at Memphis Department of Medicine
110 participants (actual enrollment reported by the registry).
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
July 1999
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
Contact the study team to confirm eligibility.
Primary Completion
August 2005
Actual (reported)Study Completion
August 2005
Actual (reported)Last Updated
May 29, 2013
Record last verified: 2013-05
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Source: ClinicalTrials.gov.
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