Infliximab

Generic Name: Infliximab

Brand Names: Avsola, Flixabi, Inflectra, Remicade, Renflexis, Zessly, Remsima

Drug Type: Biotech

Chemical Formula: -

CAS Number: 170277-31-3

Unique Ingredient Identifier: B72HH48FLU

Background: Infliximab is a tumor necrosis factor (TNF-alpha or TNF-α) blocker and a chimeric monoclonal IgG1 antibody composed of human constant (75%) and murine variable (25%) regions . Infliximab is produced by a recombinant cell line cultured by continuous perfusion. Tumor necrosis factor-alpha (TNF-α) is a key proinflammatory cytokine involved in chronic inflammato...

Indication: 用于治疗：

⑴类风湿性关节炎：本品常与甲氨蝶呤合用于中重度活动性类风湿性关节炎；

⑵克罗恩病及瘘管性克罗恩病；

⑶强直性脊柱炎等自身免疫性疾病，以减轻症状和体征，改善身体机能，预防患者残疾。

⑷用于银屑病关节炎的治疗【美国FDA已批准；英国风湿病学会/英国风湿病卫生专业人员协会《BSR／BHPR—应用生物制剂治疗银屑病关节炎指南》2012版；欧洲抗风湿病联盟《EULAR—银屑病关节炎药物治疗管理建议》2011版

】。

⑸用于6岁及以上儿童溃疡性结肠炎的治疗【美国FDA已批准；中华医学会内科学会《炎症性肠病诊断与治疗的共识意见》；中华医学会消化病学分会炎症性肠病学组《英夫利西治疗克罗恩病的推荐方案（2011年】。

Associated Conditions: Ankylosing Spondylitis (AS), Chronic Plaque Psoriasis, Fistulizing Crohn's Disease, Moderately to Severely Active Crohn's Disease, Moderately to Severely Active Rheumatoid Arthritis, Moderately to Severely Active Ulcerative Colitis, Pediatric Crohn’s Disease, Psoriatic Arthritis

Associated Therapies: -

Clinical Trials

Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery

Phase 4

Completed

Conditions: Crohn's Disease

Interventions: Drug: infliximab
Drug: placebo

First Posted Date: 2008-06-03

Last Posted Date: 2016-09-26

Lead Sponsor: University of Pittsburgh

Target Recruit Count: 24

Registration Number: NCT00688636

Locations: 🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab (Study P04440)

Phase 4

Terminated

Conditions: Spondylitis, Ankylosing
SpA

Interventions: Procedure: PDUS
Drug: Infliximab

First Posted Date: 2008-05-30

Last Posted Date: 2017-03-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 7

Registration Number: NCT00686894

Safety and Efficacy of Infliximab in Palmoplantar Psoriasis

Phase 3

Completed

Conditions: Palmoplantar Psoriasis

Interventions: Drug: Placebo
Drug: Infliximab

First Posted Date: 2008-03-06

Last Posted Date: 2011-09-09

Lead Sponsor: Innovaderm Research Inc.

Target Recruit Count: 24

Registration Number: NCT00629772

Locations: 🇨🇦
Lynderm Research Inc., Markham, Ontario, Canada
🇨🇦
Innovaderm Research Laval, Laval, Quebec, Canada
🇨🇦
The Guenther Dermatology Research Center, London, Ontario, Canada

and more 2 locations

Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies

Phase 2

Completed

Conditions: Spondylarthropathies

Interventions: Drug: Placebo
Drug: infliximab

First Posted Date: 2008-01-11

Last Posted Date: 2008-01-17

Lead Sponsor: Hospital General de Mexico

Target Recruit Count: 26

Registration Number: NCT00591201

Locations: 🇲🇽
Servicio de Reumatología, Hospital General de México, México City, DF, Mexico

Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis

Phase 4

Completed

Conditions: Chronic Uveitis

Interventions: Drug: infliximab

First Posted Date: 2008-01-10

Last Posted Date: 2013-08-26

Lead Sponsor: Egla C. Rabinovich

Target Recruit Count: 13

Registration Number: NCT00589628

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Stop Infliximab in Patients With Crohn's Disease

Phase 3

Completed

Conditions: Crohn Disease

First Posted Date: 2007-12-12

Last Posted Date: 2010-07-23

Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Target Recruit Count: 126

Registration Number: NCT00571337

Locations: 🇫🇷
CHRU Lille, Lille, France
🇧🇪
Gent University Hospital, Gent, Belgium
🇫🇷
Chu Toulouse, Toulouse, France

and more 20 locations

Off Label Use of Infliximab in Adult Patients With Severe Eosinophilic Esophagitis

Phase 2

Completed

Conditions: Esophagitis

Interventions: Drug: Infliximab

First Posted Date: 2007-08-31

Last Posted Date: 2009-04-07

Lead Sponsor: Swiss EE Study Group

Registration Number: NCT00523354

Locations: 🇨🇭
EE-Clinics, Praxis Roemerhof, Olten, SO, Switzerland

Medical Treatment of Colitis in Patients With Hermansky-Pudlak Syndrome

Phase 2

Withdrawn

Conditions: Hermanski-Pudlak Syndrome
Colitis
Cytokines
Lymphocytes
Drug Evaluation

Interventions: Drug: Corticosteroids
Drug: Tacrolimus
Drug: Mesalamine
Drug: 6-Mercaptopurine
Drug: Infliximab
Drug: Adalimumab

First Posted Date: 2007-08-10

Last Posted Date: 2017-07-02

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Registration Number: NCT00514982

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C

Phase 2

Completed

Conditions: Hepatitis C

Interventions: Drug: Placebo
Drug: Infliximab

First Posted Date: 2007-08-07

Last Posted Date: 2017-09-13

Lead Sponsor: Nizar Zein

Target Recruit Count: 146

Registration Number: NCT00512278

Locations: 🇺🇸
Cedars-Sinai Medical Center, Center for Liver Disease and Transplantation, Los Angeles, California, United States
🇺🇸
Case Medical Center, Cleveland, Ohio, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 4 locations

Infliximab and Methotrexate in Ankylosing Spondylitis

Phase 4

Completed

Conditions: Ankylosing Spondylitis

Interventions: Drug: infliximab

First Posted Date: 2007-07-26

Last Posted Date: 2017-01-16

Lead Sponsor: University Hospital, Tours

Target Recruit Count: 30

Registration Number: NCT00507403

Locations: 🇫🇷
University hospital of Tours, Tours, France
🇫🇷
University Hospital Jean MINJOZ -Besançon, Besancon, France

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