Acthar Gel ( DrugBank: - )


6 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎6
46悪性関節リウマチ4
49全身性エリテマトーデス2
50皮膚筋炎/多発性筋炎1
84サルコイドーシス6
222一次性ネフローゼ症候群3

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01906684
(ClinicalTrials.gov)
August 201319/7/2013Comprehensive Analysis of Relapse in Multiple SclerosisComprehensive Analysis of Relapse in Multiple SclerosisMultiple SclerosisDrug: Acthar GelTanner Foundation for Multiple SclerosisQuestcor Pharmaceuticals, Inc.;Auburn University MRI Research Center;iReportoire IncNot yet recruiting19 Years65 YearsBoth20N/AUnited States
2NCT02290444
(ClinicalTrials.gov)
August 201323/10/2014Effects of Acthar on Recovery From Cognitive Relapses in MSEffects of Adrenocorticotropic Hormone (ACTHAR Gel) on Recovery From Cognitive Relapses in Multiple SclerosisMultiple SclerosisDrug: Adrenocorticotropic HormoneState University of New York at BuffaloNULLCompleted18 Years65 YearsAll64Phase 3United States
3NCT01900093
(ClinicalTrials.gov)
July 201311/7/2013Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS RelapsesAn Open-Label Prospective Proof-Of-Concept Trial to Evaluate the Response to Acthar Gel Therapy in Patients With Multiple Sclerosis (MS) Relapses Who Have Failed To Make an Adequate Recovery After Treatment With High-Dose Intravenous MethylprednisoloneMultiple SclerosisDrug: Acthar GelAaron MillerMallinckrodtRecruiting18 Years65 YearsAll10N/AUnited States
4NCT01838174
(ClinicalTrials.gov)
May 201318/4/2013A Trial of Neuroprotection With ACTH in Acute Optic NeuritisA Phase IV Trial of Neuroprotection With ACTH in Acute Optic NeuritisMultiple SclerosisDrug: ACTHAR Gel (ACTH);Drug: IV methylprednisolone (steroids)University of Colorado, DenverMallinckrodt;University of PennsylvaniaTerminated18 Years55 YearsAll100Phase 4United States
5NCT01888354
(ClinicalTrials.gov)
April 201316/5/2013Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS ExacerbationsPilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ) Versus ACTHar Gel Five Days SQ for the Treatment of MS ExacerbationsMultiple Sclerosis (MS)Drug: H.P. Acthar Gel (repository corticotropin injection)The University of Texas Health Science Center, HoustonNULLCompleted18 Years55 YearsBoth25Phase 4United States
6NCT01049451
(ClinicalTrials.gov)
November 200913/1/2010Pulse ACTH vs. MP for MSComparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif)Multiple SclerosisDrug: ACTH;Drug: MethylprednisoloneUniversity of Southern CaliforniaNULLCompleted18 Years65 YearsAll23Phase 1United States

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03082573
(ClinicalTrials.gov)
March 3, 201713/3/2017Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar GelOpen-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Were Treated With H.P. Acthar Gel After an Incomplete Response to Combinations of DMARDs and Biologic DMRADsRheumatoid ArthritisDrug: H.P. Acthar gelIraj Sabahi Research Inc.MallinckrodtRecruiting21 YearsN/AAll30Phase 4United States
2NCT02919761
(ClinicalTrials.gov)
November 7, 201626/9/2016Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid ArthritisA Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD TreatmentArthritis, RheumatoidDrug: Acthar Gel;Drug: PlaceboMallinckrodtNULLCompleted18 YearsN/AAll259Phase 4United States;Argentina;Mexico;Peru;Puerto Rico;Colombia
3NCT02030028
(ClinicalTrials.gov)
November 20146/1/2014ACTH Gel Therapy in Rheumatoid ArthritisOpen Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid ArthritisRheumatoid ArthritisDrug: ACTHAR gelDana AschermanMallinckrodtCompleted18 Years100 YearsAll20N/AUnited States
4NCT02434757
(ClinicalTrials.gov)
February 201430/4/2015Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid ArthritisAddition of H. P Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis Inadequately Controlled With Biologic Disease-Modifying Antirheumatic DrugsRheumatoid ArthritisDrug: H.P. Acthar GelRonald J. Rapoport, MDQuestcor Pharmaceuticals, Inc.Recruiting18 YearsN/ABoth10N/AUnited States

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02953821
(ClinicalTrials.gov)
December 16, 20161/11/2016Acthar Gel for Active Systemic Lupus Erythematosus (SLE)A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose CorticosteroidsLupus Erythematosus, SystemicDrug: Acthar Gel;Drug: Placebo GelMallinckrodtNULLCompleted18 YearsN/AAll172Phase 4United States;Argentina;Chile;Mexico;Peru;Colombia
2NCT01769937
(ClinicalTrials.gov)
October 201215/1/2013Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus ErythematosusA Single-site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection)an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)Lupus Erythematosus Systemic ExacerbationDrug: H.P. Acthar GelFiechtner, Justus J., M.D., P.C.NULLCompleted18 Years75 YearsBoth10Phase 4United States

50. 皮膚筋炎/多発性筋炎


臨床試験数 : 194 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02245841
(ClinicalTrials.gov)
June 15, 201511/9/2014Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of DermatomyositisEfficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of DermatomyositisDermatomyositis;Juvenile DermatomyositisDrug: H.P. Acthar GelThe Cleveland ClinicMallinckrodtCompleted18 YearsN/AAll15Phase 4United States

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02523092
(ClinicalTrials.gov)
October 202010/8/2015Use of CXCL9 as a Biomarker of Acthar EfficacyUse of CXCL9 as a Biomarker of Acthar EfficacySarcoidosisDrug: Acthar gelUniversity of California, San FranciscoMallinckrodtNot yet recruiting18 Years65 YearsAll14Phase 4United States
2NCT03320070
(ClinicalTrials.gov)
February 21, 201820/10/2017Acthar Gel in Participants With Pulmonary SarcoidosisA Multicenter, Randomized, Double Blind, Placebo Controlled Exploratory Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Pulmonary SarcoidosisSarcoidosis, PulmonaryDrug: Acthar Gel;Drug: PlaceboMallinckrodtNULLCompleted18 Years90 YearsAll55Phase 4United States
3NCT02298491
(ClinicalTrials.gov)
May 201614/11/2014CNS Sarcoidosis and Acthar GelClinical Biomarkers of Disease Activity and Treatment Responses in Patients With CNS Sarcoidosis Treated With H.P. Acthar GelCNS SarcoidosisDrug: H.P. Acthar GelUniversity of Maryland, BaltimoreMallinckrodtCompletedN/AN/AAll4Phase 4United States
4NCT02348905
(ClinicalTrials.gov)
March 201520/6/2014ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label TrialACTHAR Gel for Cutaneous Sarcoidosis: An Open Label TrialSarcoidosis;Cutaneous SarcoidosisDrug: ACTHAR Gel 40 units twice weekly;Drug: ACTHAR Gel 80 units twice weekly.Albany Medical CollegeNULLNot yet recruiting18 YearsN/ABoth10Phase 2/Phase 3United States
5NCT02155803
(ClinicalTrials.gov)
February 201530/5/2014ACTHAR GEL for Sarcoidosis-Associated Calcium Dysregulation: An Open-label Pilot StudyACTHAR GEL for Sarcoidosis-Associated Calcium Dysregulation: An Open-label Pilot StudySarcoidosis;Hypercalcemia Due to SarcoidosisDrug: ACTHAR Gel (adrenocorticotropic hormone)Albany Medical CollegeNULLNot yet recruiting18 YearsN/ABoth10Phase 2/Phase 3United States
6NCT02188017
(ClinicalTrials.gov)
June 201424/4/2014Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)Sarcoidosis;Pulmonary SarcoidosisDrug: Acthar gelUniversity of CincinnatiMallinckrodtRecruiting18 Years90 YearsBoth20Phase 4United States

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02633046
(ClinicalTrials.gov)
October 10, 201615/12/2015Acthar for Treatment-Resistant or Treatment-Intolerant ProteinuriaTreatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)Idiopathic Focal Segmental GlomerulosclerosisDrug: Acthar GelMallinckrodt ARD LLCNULLCompleted18 YearsN/AAll63Phase 4United States;Argentina;Australia;Chile;Mexico;Peru;Turkey;Canada;Hong Kong;New Zealand;Puerto Rico
2NCT01386554
(ClinicalTrials.gov)
August 201129/6/2011Acthar for Treatment of Proteinuria in Membranous Nephropathy PatientsA Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of H.P. Acthar Gel (Acthar) in Treatment-Resistant Subjects With Persistent Proteinuria and Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy (iMN)Proteinuria;Idiopathic Membranous NephropathyDrug: Repository Corticotropin Injection;Drug: PlaceboMallinckrodtNULLCompleted18 YearsN/AAll60Phase 4United States;Canada;Chile;Mexico;Turkey
3NCT01155141
(ClinicalTrials.gov)
September 200929/6/2010Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTHIdiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTHKidney DiseasesDrug: H.P. Acthar GelStanford UniversityMallinckrodtCompleted16 Years65 YearsAll15Phase 4United States