Treatment of diffuse systemic sclerosis with hyperimmune caprine serum (AIMSPRO): A phase II double-blind placebo-controlled trial

Annals of the Rheumatic Diseases

Volumn 73, Issue 1, 2014, Pages 56-61

  Quillinan, N P ^a   McIntosh, D ^b   Vernes, J ^c   Haq, S ^b   Denton, C P ^a  

^a ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

^b Daval International Ltd   (United Kingdom)

^c UNIVERSITY OF KENT   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; HYPERIMMUNE CAPRINE SERUM; IMMUNOLOGIC AGENT; INTERLEUKIN 2 RECEPTOR; PLACEBO; PROCOLLAGEN TYPE 3 AMINOPROPEPTIDE; UNCLASSIFIED DRUG; VON WILLEBRAND FACTOR;

ADULT; ADVERSE OUTCOME; ARTHRALGIA; ARTICLE; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CONTROLLED STUDY; DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS; DIFFUSE SCLERODERMA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FINGER ULCER; HUMAN; INFECTION; INJECTION SITE REACTION; MALE; MIDDLE AGED; MODIFIED RODNAN SKIN SCORE; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SKIN PRURITUS; TREATMENT RESPONSE;

AUTOIMMUNE DISEASES; DMARDS (BIOLOGIC); SYSTEMIC SCLEROSIS; TREATMENT;

ADULT; AGED; ANIMALS; BIOLOGICAL MARKERS; FEASIBILITY STUDIES; FEMALE; GOATS; HUMANS; IMMUNE SERA; IMMUNOLOGIC FACTORS; MALE; MIDDLE AGED; PILOT PROJECTS; SCLERODERMA, DIFFUSE; TREATMENT OUTCOME;

EID: 84889677536     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2013-203674     Document Type: Article

References (21)

1. Shand L, Lunt M, Nihtyanova S, et al. Relationship between change in skin score and disease outcome in diffuse cutaneous systemic sclerosis: application of a latent linear trajectory model. Arthritis Rheum 2007;56:2422-31. (Pubitemid 47173590)
2. LeRoy EC, Black C, Fleischmajer R, et al. Scleroderma (systemic sclerosis): classification, subsets and pathogenesis. J Rheumatol 1988;15:202-5. (Pubitemid 18073738)
3. Nihtyanova SI, Tang EC, Coghlan JG, et al. Improved survival in systemic sclerosis is associated with better ascertainment of internal organ disease: a retrospective cohort study. QJM 2010;103:109-15.
4. Denton CP. Therapeutic targets in systemic sclerosis. Arthritis Res Ther 2007;9(Suppl 2):S6.
5. Postlethwaite AE, Wong WK, Clements P, et al. A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease. Arthritis Rheum 2008;58:1810-22. (Pubitemid 351847536)
6. Quillinan NP, Denton CP. Disease modifying treatment in Systemic Sclerosis: current status. Curr Opin Rheumatol 2009;21:636-41.
7. Kowal-Bielecka O, Landewe R, Avouac J, et al. EULAR recommendations for the treatment of systemic sclerosis: a report from the EULAR Scleroderma Trials and Research group (EUSTAR). Ann Rheum Dis 2009;68:620-8.
8. Moore CEG, Hannan R, McIntosh D. In vivo, human peripheral nerve strength duration time constant changes with Aimspro implicate altered sodium channel function as a putative mechanism of action. J Neurol Sci 2005;238:S238.
9. Subcommittee for Scleroderma Criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee. Preliminary criteria for the classification of systemic sclerosis (scleroderma). Arthritis Rheum 1980;23:581-90.
10. Khanna D, Furst DE, Hays RD, et al. Minimally important difference in diffuse systemic sclerosis: results from the D-penicillamine study. Ann Rheum Dis 2006;65:1325-9. (Pubitemid 44620441)
11. Steen VD, Medsger TA Jr. The value of the Health Assessment Questionnaire and special patient-generated scales to demonstrate change in systemic sclerosis patients over time. Arthritis Rheum 1997;40:1984-91. (Pubitemid 27494658)
12. Serednicka K, Smyth AE, Black CM, et al. Using a self-reported functional score to assess disease progression in systemic sclerosis. Rheumatology 2007;46:1107-10. (Pubitemid 47050612)
13. Chung L, Denton CP, Distler O, et al. Clinical trial design in scleroderma. Clin Exp Rheumatol 2012;30:S97-102.
14. Lydersen S, Langaas M, Bakke Ø. The exact unconditional z-pooled test for equality of two binomial probabilities: optimal choice of the berger and Boos Confidence coefficient. J Stat Comput Simulation 82:1311-16.
15. Levy Y, Amital H, Langevitz P, et al. Intravenous immunoglobulin modulates cutaneous involvement and reduces skin fibrosis in systemic sclerosis: an open-label study. Arthritis Rheum 2004;50:1005-7. (Pubitemid 38326203)
16. Denton CP, Engelhart M, Tvede N, et al. An open-label pilot study of infliximab therapy in diffuse cutaneous systemic sclerosis. Ann Rheum Dis 2009;68:1433-9.
17. Denton CP, Merkel PA, Furst DE, et al. Recombinant human anti-transforming growth factor beta1 antibody therapy in systemic sclerosis: a multicenter, randomized, placebo-controlled phase I/II trial of CAT-192. Arthritis Rheum 2007;56:323-33. (Pubitemid 46106206)
18. Merkel PA, Silliman NP, Clements PJ, et al. Patterns and predictors of change in outcome measures in clinical trials in scleroderma: an individual patient meta-analysis of 629 subjects with diffuse cutaneous systemic sclerosis. Arthritis Rheum 2012;64:3420-9.
19. Gliddon AE, Doré CJ, Black CM, et al. Prevention of vascular damage in scleroderma and autoimmune Raynaud's phenomenon: a multicenter, randomized, double-blind, placebo-controlled trial of the angiotensin-converting enzyme inhibitor quinapril. Arthritis Rheum 2007;56:3837-46. (Pubitemid 350100716)
20. Lee YJ, Shin KC, Kang SW, et al. Type III procollagen N-terminal propeptide, soluble interleukin-2 receptor, and von Willebrand factor in systemic sclerosis. Clin Exp Rheumatol 2001;19:69-74. (Pubitemid 32203849)
21. Khanna D, Saggar R, Mayes MD, et al. A one-year, phase I/IIa, open-label pilot trial of imatinib mesylate in the treatment of systemic sclerosis-associated active interstitial lung disease. Arthritis Rheum 2011;63:3540-6.