Infliximab (IFX) ( DrugBank: Infliximab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎2

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
agemin
Inclusion_
agemax
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size
PhaseCountries
1EUCTR2019-003068-39-NL
(EUCTR)
20/11/201904/11/2019In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Infliximab
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
UMC UtrechtNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Netherlands
2NCT00537316
(ClinicalTrials.gov)
July 200728/9/2007Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)Ulcerative ColitisBiological: Infliximab (IFX);Drug: Azathioprine (AZA);Drug: Placebo to Azathioprine;Drug: Placebo infusionMerck Sharp & Dohme Corp.NULLTerminated21 YearsN/AAll242Phase 3Argentina;Belgium;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Poland;Portugal;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom