Treatment of rheumatoid arthritis with oral type II collagen: Results of a multicenter, double-blind, placebo-controlled trial

Arthritis and Rheumatism

Volumn 41, Issue 2, 1998, Pages 290-297

  Barnett, Martha L ^a   Kremer, Joel M ^c   St Clair, E William ^d   Clegg, Daniel O ^e   Furst, Daniel ^f   Weisman, Michael ^g   Fletcher, Malcolm J F ^h   Chasan Taber, Scott ⁱ   Finger, Eduardo ^b   Morales, Alejandro ^b   Le, Christine H ^b   Trentham, David E ^b  

^a UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c ALBANY MEDICAL COLLEGE   (United States)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

^e UNIVERSITY OF UTAH   (United States)

^f BENAROYA RESEARCH INSTITUTE   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h AutoImmune Inc   (United States)

ⁱ Boston Biostatistics Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AUTOANTIGEN; COLLAGEN TYPE 2; PLACEBO;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; INFLAMMATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS;

ADMINISTRATION, ORAL; ADULT; AGED; ARTHRITIS, RHEUMATOID; COLLAGEN; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PLACEBOS; TREATMENT OUTCOME;

EID: 0031886916     PISSN: 00043591     EISSN: None     Source Type: Journal    
DOI: 10.1002/1529-0131(199802)41:2<290::AID-ART13>3.0.CO;2-R     Document Type: Article

References (30)

1. Sewell KL, Trentham DE. Pathogenesis of rheumatoid arthritis. Lancet 1993;341:283-6.
2. Mowat A. The regulation of the immune responses to dietary protein antigens. Immunol Today 1987;8:93-8.
3. Higgins PJ, Weiner HL. Suppression of experimental autoimmune encephalomyelitis by oral administration of myelin basic protein and its fragments. J Immunol 1988;140:440-5.
4. Bitar DM, Whitacre CC, Suppression of experimental autoimmune encephalomyelitis by the oral administration of myelin basic protein. Cell Immunol 1988;112:364-70.
5. Nagler-Anderson C, Bobber LA, Robinson ME, Siskind GW, Thorbecke GJ. Suppression of type II collagen-induced arthritis by intragastric administration of soluble type II collagen. Proc Natl Acad Sci U S A 1986;83:7443-6.
6. Thompson HSG, Staines NA. Gastric administration of type II collagen delays the onset and severity of collagen-induced arthritis in rats. Clin Exp Immunol 1986;64:581-6.
7. Zhang ZY, Lee CS, Lider O, Weiner HL. Suppression of adjuvant arthritis in Lewis rats by oral administration of type II collagen. J Immunol 1990;145:2489-93.
8. Yoshino S, Quattrocchi E, Weiner HL. Suppression of antigen-induced arthritis in Lewis rats by oral administration of type II collagen. Arthritis Rheum 1995;38:1092-6.
9. Weiner HL, Mackin GA, Matsui M, Orav EJ, Khoury SJ, Dawson DM. Double-blind pilot trial of oral tolerization with myelin antigens in multiple sclerosis. Science 1993;259:1321-4.
10. Trentham DE, Dynesius-Trentham RA, Orav EJ, Combitchi D, Lorenzo C, Sewell KL, et al. Effects of oral administration of type II collagen on rheumatoid arthritis. Science 1993;261:1727-30.
11. Sieper J, Kary S, Sörensen H, Alten R, Eggens U, Hüge W, et al. Oral type II collagen treatment in early rheumatoid arthritis: a double-blind, placebo-controlled, randomized trial. Arthritis Rheum 1996;39:41-51.
12. Khoury SJ, Hancock WW, Weiner HL. Oral tolerance to myelin basic protein and natural recovery from experimental autoimmune encephalomyelitis are associated with downregulation of inflammatory cytokines and differential upregulation of transforming growth factor β, interleukin 4, and prostaglandin E expression in the brain. J Exp Med 1992;176:1355-64.
13. Friedman A, Weiner HL. Induction of anergy or active suppression following oral tolerance is determined by antigen dosage. Proc Natl Acad Sci U S A 1994;91:6688-92.
14. Chen Y, Inobe J, Marks R, Gonnella P, Kuchroo VK, Weiner HL. Peripheral deletion of antigen-reactive T cells in oral tolerance. Nature 1995;376:177-80.
15. Barnett ML, Combitchi D, Trentham DE. A pilot trial of oral type II collagen in the treatment of juvenile rheumatoid arthritis. Arthritis Rheum 1996;39:623-8.
16. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24.
17. Steinbrocker O, Traeger CH, Batterman RC. Therapeutic criteria in rheumatoid arthritis. JAMA 1949;140:659-62.
18. Trentham DE, Townes AS, Kang AH. Autoimmunity to type II collagen: an experimental model of arthritis. J Exp Med 1977;146: 857-68.
19. Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol 1982;9:789-93.
20. Weinblatt ME, Coblyn JS, Fox DA, Fraser PA, Holdsworth DE, Glass DN, et al. Efficacy of low-dose methotrexate in rheumatoid arthritis. N Engl J Med 1985;312:818-22.
21. Matteson EL, Yocum DE, St. Clair EW, Achkar AA, Thakor MS, Jacobs MR, et al. Treatment of active refractory rheumatoid arthritis with humanized monoclonal antibody CAMPATH-1H administered by daily subcutaneous injection. Arthritis Rheum 1995;38:1187-93.
22. Van der Lubbe PA, Dijkmans BAC, Markusse HM, Nässander U, Breedveld FC. A randomized, double-blind, placebo-controlled study of CD4 monoclonal antibody therapy in early rheumatoid arthritis. Arthritis Rheum 1995;38:1097-106.
23. Paulus HE, Egger MJ, Ward JR, Williams HJ, and The Cooperative Systematic Studies of Rheumatic Diseases Group. Analysis of improvement in individual rheumatoid arthritis patients treated with disease-modifying antirheumatic drugs, based on the findings in patients treated with placebo. Arthritis Rheum 1990;33:477-84.
24. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
25. Cox DR. The analysis of binary data. London: Methuen; 1970.
26. Ke Y, Kapp JA. Oral antigen inhibits priming of CD8+ CTL, CD4+ T cells, and antibody responses while activating CD8+ suppressor T cells. J Immunol 1996;156:916-21.
27. Chen Y, Kuchroo VK, Inobe J, Hafler DA, Weiner HL. Regulatory T cell clones induced by oral tolerance: suppression of autoimmune encephalomyelitis. Science 1994;265:1237-40.
28. Miller A, Lider O, Weiner HL. Antigen-driven bystander suppression after oral administration of antigens. J Exp Med 1991;174:791-8.
29. Al-Sabbagh A, Miller A, Santos LMB, Weiner HL. Antigen-driven tissue-specific suppression following oral tolerance: orally administered myelin basic protein suppresses proteolipid protein-induced experimental autoimmune encephalomyelitis in the SJL mouse. Eur J Immunol 1994;24:2104-9.
30. Cook AD, Rowley MJ, Mackay IR, Gough A, Emery P. Antibodies to type II collagen in early rheumatoid arthritis: correlation with disease progression. Arthritis Rheum 1996;39:1720-7.