Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
6 participants
INTERVENTIONAL
2012-10-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Anakinra
All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
anakinra
Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Interventions
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anakinra
Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Etanercept in the 4 weeks prior to the baseline visit (Day 1)
* Adalimumab in the 8 weeks prior to the baseline visit (Day 1)
* Infliximab in the 12 weeks prior to the baseline visit (Day 1)
* Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1)
* Leflunomide in the 4 weeks prior to the baseline visit (Day 1) • Thalidomide in the 4 weeks prior to the baseline visit (Day 1)
* Cyclosporine in the 4 weeks prior to the baseline visit (Day 1)
* I.V. immunoglobulin (I.V. Ig) in the 8 weeks prior to the baseline visit (Day 1)
* 6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1)
* Colchicine, dapsone, mycophenolate mofetil \& systemic antibiotics in the 3 weeks prior to the baseline visit (Day 1)
* Corticosteroids "20mg/day or \>0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1)
2. history of immunocompromise including HIV infection
3. positive Hep B surface antigen -
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Kieron S Leslie, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco - Department of Dermatology
Locations
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San Francisco General Hospital
San Francisco, California, United States
Countries
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References
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Revuz JE, Canoui-Poitrine F, Wolkenstein P, Viallette C, Gabison G, Pouget F, Poli F, Faye O, Roujeau JC, Bonnelye G, Grob JJ, Bastuji-Garin S. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol. 2008 Oct;59(4):596-601. doi: 10.1016/j.jaad.2008.06.020.
Fitzsimmons JS, Guilbert PR. A family study of hidradenitis suppurativa. J Med Genet. 1985 Oct;22(5):367-73. doi: 10.1136/jmg.22.5.367.
Stojanov S, Kastner DL. Familial autoinflammatory diseases: genetics, pathogenesis and treatment. Curr Opin Rheumatol. 2005 Sep;17(5):586-99. doi: 10.1097/bor.0000174210.78449.6b.
Steinhoff JP, Cilursu A, Falasca GF, Guzman L, Reginato AJ. A study of musculoskeletal manifestations in 12 patients with SAPHO syndrome. J Clin Rheumatol. 2002 Feb;8(1):13-22. doi: 10.1097/00124743-200202000-00005.
Rosi YL, Lowe L, Kang S. Treatment of hidradenitis suppurativa with infliximab in a patient with Crohn's disease. J Dermatolog Treat. 2005 Feb;16(1):58-61. doi: 10.1080/09546630410024547.
Hunger RE, Surovy AM, Hassan AS, Braathen LR, Yawalkar N. Toll-like receptor 2 is highly expressed in lesions of acne inversa and colocalizes with C-type lectin receptor. Br J Dermatol. 2008 Apr;158(4):691-7. doi: 10.1111/j.1365-2133.2007.08425.x. Epub 2008 Jan 30.
Sakai A, Han J, Cato AC, Akira S, Li JD. Glucocorticoids synergize with IL-1beta to induce TLR2 expression via MAP Kinase Phosphatase-1-dependent dual Inhibition of MAPK JNK and p38 in epithelial cells. BMC Mol Biol. 2004 May 4;5:2. doi: 10.1186/1471-2199-5-2.
Leslie KS, Lachmann HJ, Bruning E, McGrath JA, Bybee A, Gallimore JR, Roberts PF, Woo P, Grattan CE, Hawkins PN. Phenotype, genotype, and sustained response to anakinra in 22 patients with autoinflammatory disease associated with CIAS-1/NALP3 mutations. Arch Dermatol. 2006 Dec;142(12):1591-7. doi: 10.1001/archderm.142.12.1591.
Sartorius K, Emtestam L, Jemec GB, Lapins J. Objective scoring of hidradenitis suppurativa reflecting the role of tobacco smoking and obesity. Br J Dermatol. 2009 Oct;161(4):831-9. doi: 10.1111/j.1365-2133.2009.09198.x. Epub 2009 Apr 29.
Other Identifiers
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11-08101
Identifier Type: -
Identifier Source: org_study_id
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