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 inflammatory diseases . Its hyperactivity and enhanced signalling pathways can be observed in inflammatory diseases where it activates further pro-inflammatory cascades. By binding to both the soluble subunit and the membrane-bound precursor of TNF-α , infliximab disrupts the interaction of TNF-α with its receptors and may also cause lysis of cells that produce TNF-α .

Infliximab was first approved by the FDA in 1998 under the market name Remicade as an intravenous injection. It is indicated for the treatment of various inflammatory disorders such as adult or pediatric Chron's disease, adult or pediatric ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondyliti, psoriatic arthritis, and plaque psoriasis . In clinical trials, multiple infusions of infliximab displayed in a reduction of signs and symptoms of inflammatory diseases and induction of remission in patients who have had an inadequate response to alternative first-line therapies for that disorder .

There are currently two biosilimars of infliximab available in the US market that demonstrate a high degree of similarity to the reference product, Remicade. They are approved for all eligible indications of the reference product. Inflectra, a first biosimilar drug product, was approved in 2016. In December 2017, Ixifi, a second biosimilar that was developed by Pfizer, was granted approval by the FDA.

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
-

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

Phase 4
Completed
Conditions
Interventions
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
Interventions
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
Interventions
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

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
Interventions
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

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

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
Interventions
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

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

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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