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

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

Phase 4

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Infliximab

First Posted Date: 2016-05-12

Last Posted Date: 2021-01-20

Lead Sponsor: Chiba University

Target Recruit Count: 211

Registration Number: NCT02770794

Locations: 🇯🇵
Chiba University Hospital, Chiba, Japan

Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

Phase 4

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: Infliximab

First Posted Date: 2016-05-12

Last Posted Date: 2024-10-08

Lead Sponsor: Austin Health

Target Recruit Count: 138

Registration Number: NCT02770040

Locations: 🇦🇺
Austin Health, Melbourne, Victoria, Australia

Clinical and Molecular Phenotyping in IBD

Not Applicable

Completed

Conditions: IBD

Interventions: Drug: Infliximab
Drug: Vedolizumab

First Posted Date: 2016-02-29

Last Posted Date: 2022-07-01

Lead Sponsor: University Hospital Schleswig-Holstein

Target Recruit Count: 90

Registration Number: NCT02694588

Locations: 🇩🇪
Medical Department I, University Hospital Schleswig-Holstein, Kiel, Germany

Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms

Phase 1

Conditions: Aneurysm
Stroke
Vasculitis
Tumor Necrosis Factor-alpha

Interventions: Drug: Infliximab

First Posted Date: 2015-12-23

Last Posted Date: 2023-08-18

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 8

Registration Number: NCT02638701

Locations: 🇺🇸
UCSF Medical Center, San Francisco, California, United States

An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease

Phase 4

Terminated

Conditions: Inflammatory Bowel Diseases

Interventions: Drug: Infliximab

First Posted Date: 2015-10-02

Last Posted Date: 2020-08-06

Lead Sponsor: Janssen Scientific Affairs, LLC

Target Recruit Count: 53

Registration Number: NCT02566889

TOPIT; Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease

Not Applicable

Conditions: Pediatric Crohns Disease

Interventions: Drug: Infliximab

First Posted Date: 2015-08-13

Last Posted Date: 2015-08-13

Lead Sponsor: Klinikum Westbrandenburg GmbH

Target Recruit Count: 120

Registration Number: NCT02522169

Top-down Infliximab Study in Kids With Crohn's Disease

Phase 4

Completed

Conditions: Crohn's Disease

Interventions: Drug: Prednisolone
Drug: Infliximab
Other: Exclusive enteral nutrition
Drug: Azathioprine

First Posted Date: 2015-08-07

Last Posted Date: 2024-03-05

Lead Sponsor: Erasmus Medical Center

Target Recruit Count: 100

Registration Number: NCT02517684

Locations: 🇳🇱
Academic Medical Center, Amsterdam, Netherlands
🇳🇱
Amphia Hospital, Breda, Netherlands
🇳🇱
Radboud University Medical Center, Nijmegen, Netherlands

and more 10 locations

A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's Disease

Phase 3

Completed

Conditions: Behcet Disease

Interventions: Drug: Infliximab

First Posted Date: 2015-07-22

Last Posted Date: 2019-10-17

Lead Sponsor: Janssen Korea, Ltd., Korea

Target Recruit Count: 33

Registration Number: NCT02505568

The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease

Conditions: Inflammatory Bowel Disease
Crohn's Disease

Interventions: Drug: Infliximab
Drug: thiopurine

First Posted Date: 2015-05-25

Last Posted Date: 2017-02-16

Lead Sponsor: Ernest Seidman

Target Recruit Count: 225

Registration Number: NCT02453607

Locations: 🇨🇦
Montreal General Hospital, Montreal, Quebec, Canada

A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis

Phase 4

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: Azathioprine
Drug: Infliximab
Drug: Prednisolone
Drug: Hydrocortisone

First Posted Date: 2015-04-24

Last Posted Date: 2023-05-31

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

Target Recruit Count: 65

Registration Number: NCT02425852

Locations: 🇫🇷
APHP- Hopital BEAUJON, Clichy, France
🇫🇷
Hopital St Antoine, Paris, France
🇫🇷
Chu Besancon, Besancon, France

and more 13 locations

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