- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02769702
Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis
Prospective Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis Who Are Not Well Controlled With, or Intolerant of, Topical or Systemic Corticosteroids
Uveitis is an acute or chronic inflammatory condition of unknown etiology. Although uveitis often responds adequately to topical corticosteroids, there are many patients for which this treatment is either inadequate or not tolerated. A patient with inadequate response to treatment would manifest uveitis activity by slit lamp examination determination of anterior chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension (greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid administration, leading to glaucoma and permanent visual loss. Moreover, systemic corticosteroids may be required at a dose unsafe for chronic administration. In these situations, an immunosuppressive medication is often added as a "steroid-sparing" agent. If and when there is clinical response to the added immunosuppressive, the oral and/or topical corticosteroid dose can be reduced or eliminated to avoid toxicity.
There are several reasons for believing that Acthar might be beneficial in the treatment of uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has another important mechanisms of action mediated by its binding of melanocortin receptors. Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages, there is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion molecules. In other cells, in addition to IL-10 upregulation (monocytes), there is down-regulation of VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1 and RANTES (renal tubules).CNS mediation of systemic inflammation may also be down-regulated by melanocortin receptor binding by Acthar.
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Missouri
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Saint Louis, Missouri, Forenede Stater, 63110
- Washington University in St. Louis
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Active anterior uveitis requiring oral and/or topical corticosteroid therapy
Exclusion Criteria:
- Uncontrolled diabetes
- Uncontrolled glaucoma
- HIV infection or other infection for which corticosteroid therapy contraindicated
- Contraindication to ACTHAR
- Scleroderma
- Osteoporosis
- Ocular herpes simplex
- Systemic fungal infection
- Recent surgery
- Uncontrolled hypertension
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Intervention
Acthar 80 IU SC twice w eek
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Acthar 80 IU SC twice a week
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in Eye With Uveitis of Anterior Chamber Cellularity Graded From 0-4 on a Likert Scale Determined by Slit Lamp Examination
Tidsramme: Baseline and 12 weeks
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standard assessment of uveitis activity.
Scores were assessed using a Likert scale using 0 to 4, higher score reflects more cellularity.
|
Baseline and 12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Baseline in Eye With Uveitis of Anterior Chamber Protein Graded 0-4 on a Likert Scale Determined by Slit Lamp Evaluation
Tidsramme: Baseline and 12 weeks
|
standard assessment of uveitis activity.
Scores were assessed using a Likert scale using 0 to 4, higher score reflects more protein.
|
Baseline and 12 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Richard D Brasington, MD, Washington U Rheumatology
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Acthar Uveitis Study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Uveitis
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Priovant Therapeutics, Inc.Aktiv, ikke rekrutterendeIkke-infektiøs mellemliggende uveitis | Ikke-infektiøs posterior uveitis | Ikke-infektiøs Pan UveitisForenede Stater
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University of NebraskaUkendtPosterior Uveitis | Mellemliggende uveitis | Pan-uveitisForenede Stater
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Stanford UniversitySanten Inc.Trukket tilbagePanuveitis | Uveitis | Posterior Uveitis | Mellemliggende uveitisForenede Stater
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CHU de Quebec-Universite LavalAfsluttetMellemliggende uveitis | Anterior UveitisCanada
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EyePoint Pharmaceuticals, Inc.AfsluttetPanuveitis | Posterior Uveitis | Mellemliggende uveitisIndien
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Johns Hopkins UniversityMacuSight, Inc.AfsluttetPanuveitis | Uveitis | Posterior Uveitis | Mellemliggende uveitisForenede Stater
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Duke UniversityAfsluttetPosterior Uveitis | Mellemliggende uveitisForenede Stater
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AllerganAfsluttetPosterior Uveitis | Mellemliggende uveitisFrankrig, Det Forenede Kongerige, Forenede Stater, Spanien, Polen, Indien, Sydafrika, Korea, Republikken, Canada, Tjekkiet, Australien, Tyskland, Israel, Schweiz, Portugal, Østrig, Brasilien, Grækenland
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The New York Eye & Ear InfirmaryUkendtPanuveitis | Uveitis | Posterior Uveitis | Anterior UveitisForenede Stater
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Novartis PharmaceuticalsAfsluttetIkke-infektiøs mellemliggende uveitis | Ikke-infektiøs posterior uveitis | Ikke-infektiøs panuveitisForenede Stater, Det Forenede Kongerige
Kliniske forsøg med Acthar
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Icahn School of Medicine at Mount SinaiAfsluttet
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MallinckrodtAfsluttetGigt, reumatoidForenede Stater, Puerto Rico, Mexico, Peru, Argentina
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Phoenix Neurological Associates, LTDUkendt
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University of Colorado, DenverAktiv, ikke rekrutterende
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Greater Boston Medical AssociatesMassachusetts General HospitalUkendtNedsættelse af proteinuri med H.P. Acthar Gel og dens virkninger på klinisk og podocytfunktionForenede Stater
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IRIS Research and Development, LLCMallinckrodtAfsluttet
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MallinckrodtAfsluttet
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Ohio State UniversityMallinckrodtTrukket tilbageSLE Glomerulonephritis Syndrome, WHO Klasse VForenede Stater
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Tampa Bay Uveitis Center, LLCMallinckrodtAfsluttetUveitis | Posterior Uveitis | Mellemliggende uveitis | Anterior Uveitis | Skleritis | Klinisk signifikant makulært ødemForenede Stater
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Tanner Foundation for Multiple SclerosisMallinckrodt; Auburn University MRI Research Center; iReportoire IncUkendt