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

EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis

Phase 2

Not yet recruiting

Conditions: Immune-related Colitis

Interventions: Drug: Methoxsalen
Drug: Infliximab
Drug: Vedolizumab

First Posted Date: 2024-10-17

Last Posted Date: 2024-11-07

Lead Sponsor: Therakos, LLC, a Mallinckrodt Company

Target Recruit Count: 30

Registration Number: NCT06646016

Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab

Phase 3

Not yet recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: Infliximab

First Posted Date: 2024-09-26

Last Posted Date: 2024-09-26

Lead Sponsor: JAROSLAW KIERKUS

Target Recruit Count: 60

Registration Number: NCT06614387

Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

Completed

Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis

Interventions: Drug: Infliximab
Drug: Adalimumab

First Posted Date: 2024-02-21

Last Posted Date: 2024-10-28

Lead Sponsor: Vastra Gotaland Region

Target Recruit Count: 271

Registration Number: NCT06269185

Locations: 🇸🇪
Västra Götalandsregionen, Göteborg, Sweden

Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

Phase 2

Recruiting

Conditions: Depressive Disorder, Major
Inflammation

Interventions: Other: Placebo
Drug: Infliximab

First Posted Date: 2023-11-18

Last Posted Date: 2024-12-18

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 100

Registration Number: NCT06136546

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

Phase 4

Recruiting

Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis

Interventions: Drug: Infliximab

First Posted Date: 2023-11-02

Last Posted Date: 2024-07-26

Lead Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

Target Recruit Count: 275

Registration Number: NCT06113913

Locations: 🇧🇪
Universitair ziekenhuis Antwerpen, Antwerp, Belgium
🇧🇪
AZ Sint-Jan Brugge, Brugge, Belgium
🇧🇪
Ziekenhuis Oost-Limburg, Genk, Belgium

and more 12 locations

Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD

Not Applicable

Recruiting

Conditions: Crohn's Disease

Interventions: Drug: Infliximab-Dyyb

First Posted Date: 2023-10-03

Last Posted Date: 2024-05-14

Lead Sponsor: Asan Medical Center

Target Recruit Count: 100

Registration Number: NCT06064864

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

Therapeutic Monitoring of Infliximab and Adalimumab

Recruiting

Conditions: Inflammatory Bowel Diseases

Interventions: Drug: Infliximab
Drug: Adalimumab

First Posted Date: 2023-09-13

Last Posted Date: 2024-06-14

Lead Sponsor: IRCCS Burlo Garofolo

Target Recruit Count: 100

Registration Number: NCT06033469

Locations: 🇮🇹
Ospedale Maggiore, Bologna, Italy
🇮🇹
IRCCS Burlo Garofolo, Trieste, Italy
🇮🇹
Ospedale Ca' Foncello, Treviso, Italy

Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis

Phase 3

Recruiting

Conditions: Colitis

Interventions: Drug: Infliximab
Drug: Methylprednisolone
Drug: Prednisolone

First Posted Date: 2023-07-17

Last Posted Date: 2023-08-24

Lead Sponsor: Odense University Hospital

Target Recruit Count: 195

Registration Number: NCT05947669

Locations: 🇬🇧
The Royal Marsden Hospital, London, United Kingdom
🇩🇰
Department of Oncology, Aalborg University Hospital, Aalborg, Denmark
🇩🇰
Department of Oncology Odense University Hospital, Odense, Denmark

AppenDectomy Vs ANti TNF-a in Inducing Clinical and EnDoscopic Remission in Left-sided Ulcerative Colitis

Not Applicable

Not yet recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: Infliximab
Procedure: Appendectomy

First Posted Date: 2023-07-05

Last Posted Date: 2023-07-05

Lead Sponsor: Federico II University

Target Recruit Count: 94

Registration Number: NCT05931458

Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients

Phase 4

Recruiting

Conditions: Crohn Disease

Interventions: Drug: Infliximab

First Posted Date: 2023-06-18

Last Posted Date: 2024-04-11

Lead Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

Target Recruit Count: 30

Registration Number: NCT05906576

Locations: 🇨🇳
Beijing Children's Hospital, Capital Medical University, Beijing, China

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