Remicade

(Infliximab)

ApprovedMonoclonal antibody

Infliximab is used to treat inflammatory diseases like rheumatoid arthritis, Crohn's disease, and psoriasis by reducing the body's immune system overactivity that causes inflammation and pain.[2] Remicade is currently approved and in use across 88 indications[4].[1]

Remicade is one of 1467 small molecule programs targeting Cachexia. It is currently in Approved.

Indications

310

Total Trials

Active Trials

1,466

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

CachexiaActive, not recruiting

Relapsing PolychondritisActive, not recruiting

ColitisActive, not recruiting

Polymyalgia RheumaticaActive, not recruiting

Pemphigus VulgarisActive, not recruiting

Low Back PainActive, not recruiting

Ischemia Reperfusion InjuryActive, not recruiting

Stevens-Johnson SyndromeActive, not recruiting

ArthritisActive, not recruiting

Rheumatic DiseaseRecruiting

CachexiaPhase 3

Active, not recruiting

Relapsing PolychondritisPhase 2

Active, not recruiting

ColitisPhase 3

Active, not recruiting

Polymyalgia RheumaticaPhase 3

Active, not recruiting

Pemphigus VulgarisPhase 2

Active, not recruiting

Low Back PainPhase 3

Active, not recruiting

Ischemia Reperfusion InjuryPhase 2

Active, not recruiting

Stevens-Johnson SyndromePhase 1

Active, not recruiting

ArthritisPhase 3

Active, not recruiting

Rheumatic DiseasePhase 2

Recruiting

Showing 10 of 84 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Remicade

OOrganon and Co

Approved

1 2

Adriamycin

GGynecologic Oncology Group

Preclinical

87 3

Megace

Bristol-Myers Squibb

Preclinical

4 4

Lexiscan

Astellas

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

Avastin

Roche

Preclinical

4 8

Fentanyl Citrate

IINSYS Therapeutics Inc

Preclinical

2 9

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

1 10

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Crohn's Disease

NCT05813860

Phase 1Recruiting

Complication

NCT03819296

Post-ApprovalRecruiting

Intravenous

NCT06113913

N/ARecruiting

Efficacy and Safety

NCT06064864

Post-ApprovalRecruiting

Ulcerative Colitis

NCT04999228

Post-ApprovalRecruiting

Immunosuppression

NCT05043870

Clinical

Trials by Indication[1]

Rheumatoid Arthritis30 trials

A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01313520·61 enrolled

Therapeutic Response to Tumor Necrosis Factor-alpha (TNF-alpha) Antagonists in Rheumatoid Arthritis.

Unknown status·UUniversity of Sulaimani··NCT05379049·80 enrolled

Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00095147·431 enrolled

Show 27 more trials

A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study

Completed·UUniversité Catholique de Louvain·Phase 4·NCT00396747·45 enrolled

Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients

Unknown status·ZZhang, Xiao, M.D.·N/A·NCT01915537·170 enrolled

A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00732875·92 enrolled

Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

Completed·CCentocor, Inc.·Phase 3·NCT00269867·428 enrolled

Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept

Completed·CCentocor Ortho Biotech Services, L.L.C.·Phase 3·NCT00317538·28 enrolled

Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

Completed·UUniversity Hospital, Strasbourg, France·Phase 4·NCT01000441·300 enrolled

RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis

Terminated·TTcLand Expression S.A.··NCT03016260·250 enrolled

Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis

Unknown status·PPeking Union Medical College Hospital·Phase 4·NCT01282528·85 enrolled

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.

Completed·CCentocor, Inc.·Phase 3·NCT00036387·347 enrolled

An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

Completed·CCelltrion·Phase 3·NCT01571219·302 enrolled

A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis

Completed·NNichi-Iko Pharmaceutical Co., Ltd.·Phase 3·NCT01927263·242 enrolled

Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis

Unknown status·GGeorgetown University·Phase 4·NCT01793519·290 enrolled

An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00896168·234 enrolled

Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis

Completed·UUniversity Hospital, Tours··NCT00840957·84 enrolled

The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol

Completed·CCentocor Ortho Biotech Services, L.L.C.·Phase 4·NCT00246064·210 enrolled

SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.

Completed·JJulia Brown·Phase 4·NCT01295151·122 enrolled

Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)

Completed·UUniversity of Leeds·Phase 4·NCT01308255·112 enrolled

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

Completed· Pfizer logo

Pfizer·Phase 3·NCT02222493·650 enrolled

Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00794898·19 enrolled

Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT02728934·1,279 enrolled

Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

Unknown status·HHvidovre University Hospital·Phase 4·NCT00216177·112 enrolled

A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)

Withdrawn· Merck & Co. logo

Merck & Co.··NCT00724672

Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.··NCT00725621·516 enrolled

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis

Completed·CCentocor, Inc.·Phase 3·NCT00036374·123 enrolled

A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

Terminated· Roche logo

Roche·Phase 2·NCT00808210·28 enrolled

Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

Completed· Amgen logo

Amgen·Phase 3·NCT02937701·558 enrolled

RESTART C0168Z05 Rheumatoid Arthritis Study

Completed·CCentocor Ortho Biotech Services, L.L.C.·Phase 4·NCT00714493·203 enrolled

Crohn's Disease17 trials

Top Down Versus Step Up Strategies in Crohn's Disease

Completed·BBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZW·Phase 4·NCT00554710·129 enrolled

Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease

Terminated·—·Phase 2/3·NCT04974099·6 enrolled

Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)

Terminated· Merck & Co. logo

Merck & Co.··NCT00705471·42 enrolled

Show 14 more trials

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

Completed·UUniversity of Pittsburgh·Phase 4·NCT00688636·24 enrolled

Infliximab, Regulatory T Cells, IL2 and Crohn's Disease

Withdrawn·OOregon Health and Science University·N/A·NCT01266785

Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)

Completed·—··NCT04131504·239 enrolled

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

Recruiting·TTaizhou Mabtech Pharmaceutical Co.,Ltd·Phase 4·NCT05906576·30 enrolled

Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)

Completed· Merck & Co. logo

Merck & Co.··NCT01349920·15 enrolled

Palmitoleic Acid Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease

Not yet recruiting·CChinese Medical Association·Phase 4·NCT07417696·400 enrolled

N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·N/A·NCT04761952·236 enrolled

An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)

Completed· Merck & Co. logo

Merck & Co.··NCT00988832·380 enrolled

Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors

Terminated·IIRCCS Burlo Garofolo·Phase 3·NCT03221166·9 enrolled

A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

Completed·JJohnson & Johnson (China) Investment Ltd.··NCT04312659·38 enrolled

HLADQA1*05 Genotype and the Efficacy of Treatment With Infliximab in Chinese Population Crohn's Disease

Not yet recruiting·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 4·NCT05813860·976 enrolled

Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.··NCT00724958·348 enrolled

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

Completed·EErasmus Medical Center·Phase 4·NCT02517684·100 enrolled

Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT00796250·9 enrolled

Ulcerative Colitis17 trials

A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT00207688·505 enrolled

Early Serum Infliximab Levels in Severe Ulcerative Colitis.

Completed·UUniversity of California, San Francisco·Phase 1·NCT01971814·11 enrolled

Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis

Unknown status·IIstituto Clinico Humanitas·Phase 4·NCT03151525·100 enrolled

Show 14 more trials

A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis

Completed·CCentocor, Inc.·Phase 3·NCT00336492·60 enrolled

Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab

Not yet recruiting·JJAROSLAW KIERKUS·Phase 3·NCT06614387·60 enrolled

Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis

Recruiting·MMedical University of Lodz·Phase 2·NCT06453317·172 enrolled

Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

Completed·VVastra Gotaland Region··NCT06269185·271 enrolled

Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 4·NCT05205603·438 enrolled

A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

Completed· Roche logo

Roche·Phase 3·NCT02136069·397 enrolled

Top Down Versus Step up in Pediatric Ulcerative Colitis

Recruiting·—·Phase 4·NCT04999228·40 enrolled

A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis

Completed·CCentocor, Inc.·Phase 3·NCT00036439·364 enrolled

Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT00984568·28 enrolled

EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis

Completed·RRennes University Hospital·Phase 4·NCT03679546·151 enrolled

Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial

Not yet recruiting·—·Phase 2·NCT07297069·60 enrolled

European Safety Registry in Ulcerative Colitis (P04808)

Completed· Merck & Co. logo

Merck & Co.··NCT00705484·2,239 enrolled

A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01804166·1 enrolled

Efficacy & 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)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT00537316·242 enrolled

Psoriasis15 trials

Efficacy and Safety of Infliximab Biosimilar in Treatment of Moderate to Severe Psoriasis; A Single-arm Clinical Trial

Active, not recruiting·SServices Institute of Medical Sciences, Pakistan·Phase 1/2·NCT06591273·104 enrolled

A Study of the Safety and Effectiveness of Infliximab in Patients With Plaque-type Psoriasis

Completed·CCentocor, Inc.·Phase 3·NCT00106847·683 enrolled

Long-Term Effects of Infliximab in the Treatment of Moderate to Severe Psoriasis [Extension of Study P04271, NCT00251641] (P04563)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT00358670·441 enrolled

Show 12 more trials

A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01177800·129 enrolled

The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00251641·868 enrolled

A Study to Evaluate Remicade (Infliximab) in Moderate-to-Severe Chronic Plaque Psoriasis in the Middle Eastern Population (Study P04528)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00687362·22 enrolled

Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP)(Study P04555)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00686686·23 enrolled

PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept

Completed·CCentocor Ortho Biotech Services, L.L.C.·Phase 3·NCT00527072·217 enrolled

A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00686595·48 enrolled

Safety and Efficacy of Infliximab in Palmoplantar Psoriasis

Completed·IInnovaderm Research Inc.·Phase 3·NCT00629772·24 enrolled

Infliximab in High Need Versus Low Need Psoriasis Patients: The IHELP Study (Study P04320)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00254982·593 enrolled

Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis

Completed·JJochen Schmitt.··NCT01812954·1 enrolled

A Study of the Safety and Efficacy of Infliximab in Patients With Psoriasis

Completed·CCentocor, Inc.·Phase 3·NCT00106834·378 enrolled

Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT00833053·39 enrolled

Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)

Completed· Pfizer logo

Pfizer··NCT03885089·10 enrolled

Infliximab14 trials

The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·N/A·NCT03393247·160 enrolled

Managing Infliximab Reinduction After Temporary Discontinuation of Drug

Withdrawn·NNYU Langone Health·Phase 3·NCT02771457

Treatment With Infliximab in a Medical Setting (Study P05587)

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT00752622·100 enrolled

Show 11 more trials

A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit

Completed·PPatrick Durez·N/A·NCT01245361·30 enrolled

The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety

Completed·TTaizhou Mabtech Pharmaceutical Co.,Ltd·Phase 1·NCT04779892·90 enrolled

Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT00521924·8 enrolled

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

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT00686894·7 enrolled

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

Completed·HHospital General de Mexico·Phase 2/3·NCT00591201·26 enrolled

Precise Infliximab Exposure and Pharmacodynamic Control

Recruiting·—·Phase 2/3·NCT05660746·180 enrolled

Topical Infliximab in Autoimmune Eyes With Keratoprosthesis

Withdrawn·—·Phase 1/2·NCT02126020

RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

Completed·AAssistance Publique - Hôpitaux de Paris·N/A·NCT00307593·20 enrolled

The HAM Infliximab Study

Terminated·IImperial College London·Phase 2·NCT00823641·3 enrolled

Infliximab Biosimilar in Takayasu's Arteritis

Unknown status·OOspedale San Raffaele··NCT03192878·30 enrolled

A Long-term Safety Study of Infliximab (Remicade)

Completed·CCentocor, Inc.··NCT00261976·2,971 enrolled

61 more indications

Inflammatory Bowel Disease12 trials

Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice

Completed·RRegionshospitalet Viborg, Skive··NCT02322008·1,035 enrolled

A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease

Not yet recruiting·EErwin Dreesen··NCT07120152·439 enrolled

Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease

Completed·IImelda GI Clinical Research Center·Phase 4·NCT04775732·187 enrolled

Show 9 more trials

"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"

Unknown status·OOnze Lieve Vrouwe Gasthuis·Phase 4·NCT02452151·300 enrolled

Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease

Completed·OOslo University Hospital··NCT02073526·1,230 enrolled

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

Unknown status·KKlinikum Westbrandenburg GmbH·N/A·NCT02522169·120 enrolled

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

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT02566889·53 enrolled

Abdominal Ultrasound With Doppler and Peripheral Hemogram in Assesment Inflammatory Bowel Disease

Completed·—··NCT03445624·60 enrolled

Biomarkers of Anti-TNF Treatment in Inflammatory Bowel Disease (IBD)

Completed·EErasmus Medical Center··NCT01971970·45 enrolled

PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease

Recruiting·PPontificia Universidad Catolica de Chile·N/A·NCT06758024·72 enrolled

Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.

Completed·RRehab Werida·N/A·NCT05291039·56 enrolled

Model-informed Dose De-escalation of Infliximab in Patients With Inflammatory Bowel Diseases

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT04982172·80 enrolled

Ankylosing Spondylitis10 trials

REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)

Unknown status·HHanyang University Seoul Hospital·Phase 4·NCT05164198·448 enrolled

Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis

Unknown status·RRheumazentrum Ruhrgebiet·N/A·NCT00237419·149 enrolled

An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement

Terminated· Johnson & Johnson logo

Johnson & Johnson··NCT02293681·76 enrolled

Show 7 more trials

Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.··NCT00725543·358 enrolled

Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.··NCT00818168·320 enrolled

Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)

Withdrawn· Merck & Co. logo

Merck & Co.·Phase 4·NCT01148901

Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00202865·76 enrolled

A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00779012·42 enrolled

Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Unknown status·JJagiellonian University·Phase 4·NCT02132234·100 enrolled

Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

Completed·AAssociation de Recherche Clinique en Rhumatologie·Phase 3·NCT00439283·240 enrolled

Efficacy and Safety7 trials

An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease

Completed·CCentocor, Inc.·Phase 2/3·NCT00269854·108 enrolled

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

Recruiting·—·N/A·NCT06064864·100 enrolled

An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease

Completed·CCentocor, Inc.·Phase 3·NCT00269841·94 enrolled

Show 4 more trials

A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC

Unknown status·GGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives··NCT04990258·444 enrolled

The Efficacy and Safety of Infliximab Combination With Azathioprine in Crohn's Disease in Children

Not yet recruiting·TThe Children's Hospital of Zhejiang University School of Medicine·N/A·NCT07424040·154 enrolled

Clinical Comparative Study to Evaluate the Efficacy and Safety of Recombinant Anti-TNF-alpha Antibodies for Injection

Unknown status·GGenor Biopharma Co., Ltd.·Phase 3·NCT04178850·568 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02505568·33 enrolled

Kawasaki Disease5 trials

Infliximab (Remicade) for Patients With Acute Kawasaki Disease

Completed·UUniversity of California, San Diego·Phase 1·NCT00271570·24 enrolled

KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)

Completed·UUniversity of California, San Diego·Phase 3·NCT03065244·105 enrolled

Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease

Withdrawn·—·Phase 3·NCT04535518

Show 2 more trials

Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial

Completed·FFudan University·Phase 3·NCT02298062·40 enrolled

Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease

Completed·UUniversity of California, San Diego·Phase 3·NCT00760435·196 enrolled

Psoriatic Arthritis4 trials

Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00367237·115 enrolled

A Study of the Safety and Effectiveness of Infliximab for the Treatment of Psoriatic Arthritis

Completed·CCentocor, Inc.·Phase 3·NCT00051623·70 enrolled

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT04610476·270 enrolled

Show 1 more trial

Tumor Necrosis Factors (TNF)-α Blockade for Psoriatic Arthritis

Completed·—·Phase 4·NCT00432406·40 enrolled

Colitis4 trials

Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT04305145·42 enrolled

Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis

Recruiting·OOdense University Hospital·Phase 3·NCT05947669·195 enrolled

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

Withdrawn·TTherakos LLC·Phase 2·NCT06646016

Show 1 more trial

Anti-TNF Therapy for Refractory Colitis in Hospitalized Children

Completed·—··NCT02799615·38 enrolled

Safety and Efficacy3 trials

A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease

Completed·CCentocor, Inc.·Phase 3·NCT00207675·112 enrolled

A Study of Safety and Efficacy of Infliximab (Remicade) in Patients With COPD

Completed·CCentocor, Inc.·Phase 3·NCT00056264·234 enrolled

Study to Assess the Safety and Efficacy of Infliximab to Treat Hidradenitis Suppurtativa

Completed·FFlorida Academic Dermatology Centers·Phase 2·NCT00795574·38 enrolled

Cohort Study3 trials

One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study

Completed· Biogen logo

Biogen··NCT03662919·2,274 enrolled

A Multicentered Prospective Cohort Study of Chinese IBD Patients

Unknown status·PPeking Union Medical College Hospital··NCT05386290·200 enrolled

A Cohort Study Comparing IFX to CS for Moderate to Severe UC

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University··NCT04879966·342 enrolled

Acute Graft Versus Host Disease2 trials

GVH 022P: Study Using Anti Tumor Necrosis Factor Antibody (Infliximab) for Treatment of Acute Graft Versus Host Disease

Completed·EEmory University·Phase 1·NCT00228839

Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease

Terminated·NNationwide Children's Hospital·Phase 2·NCT01485055·11 enrolled

Sarcoidosis2 trials

A Study of Infliximab in Patients With Sarcoidosis

Completed·CCentocor, Inc.·Phase 3·NCT00073437·139 enrolled

Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES)

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT03704610·31 enrolled

Metastatic Melanoma2 trials

Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease

Terminated·VVanderbilt-Ingram Cancer Center··NCT00897312·7 enrolled

PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT05034536·36 enrolled

Diabetic Macular Edema2 trials

Treatment of Refractory Diabetic Macular Edema With Infliximab

Terminated·UUniversity of Athens·Phase 3·NCT00505947·12 enrolled

Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema

Unknown status·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT00959725·10 enrolled

Inflammation2 trials

Dynamics of Inflammation and Its Blockade on Motivational Circuitry in Depression

Completed·EEmory University·Phase 4·NCT03006393·42 enrolled

Inflammation-Induced CNS Glutamate Changes in Depression

Terminated·EEmory University·Phase 4·NCT03004443·22 enrolled

Ovarian Reserve1 trial

Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·N/A·NCT02998827·90 enrolled

Diarrhea1 trial

An Investigational Study of Infliximab With Prednisone or Methylprednisolone Versus Prednisone Combination Treatment in Immune Related or Severe Diarrhea in Patients Treated With Yervoy and/or Opdivo

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02763761

Pancreatic Cancer1 trial

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Pancreatic Cancer Related Cachexia

Completed·CCentocor, Inc.·Phase 2·NCT00060502·73 enrolled

Completed·HHelsinki University Central Hospital·Phase 3·NCT01015547·60 enrolled

Small Bowel Crohn's Disease1 trial

The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01181765·1 enrolled

Treatment1 trial

Autologous Platelet-rich Plasma (PRP) and Thrombin Coagulum for the Topical Treatment of Rectal Mucosal Ulcers

Unknown status·XXijing Hospital of Digestive Diseases·Phase 1·NCT05912712·60 enrolled

Randomized Controlled Trial1 trial

Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)

Unknown status·GGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives·Phase 4·NCT05072782·360 enrolled

AIN1 trial

Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT00394589·43 enrolled

Methotrexate1 trial

Combination Methotrexate and Infliximab

Completed·—·Phase 4·NCT00432432·38 enrolled

Prognosis1 trial

Prognosis in UC After First Biological

Completed·TTampere University Hospital··NCT05530122·192 enrolled

Perianal Crohn's Disease1 trial

Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.

Terminated·SSheba Medical Center·N/A·NCT00252369

Ischemia1 trial

Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL)

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT02251041·143 enrolled

Autoimmune Disease1 trial

Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)

Completed·CCelltrion·Phase 3·NCT01217086·617 enrolled

Adalimumab1 trial

Therapeutic Monitoring of Infliximab and Adalimumab

Unknown status·IIRCCS Burlo Garofolo··NCT06033469·100 enrolled

Moderate to Severe Crohn's Disease1 trial

a Single-center Registered Clinical Research of Chinese Patients With Moderate to Severe Crohn's Disease

Unknown status·NNanfang Hospital, Southern Medical University··NCT02088944·142 enrolled

Inflammatory Disease1 trial

Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)

Completed· Merck & Co. logo

Merck & Co.··NCT00727298·4,485 enrolled

Hepatitis C1 trial

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

Completed·NNizar Zein·Phase 2·NCT00512278·146 enrolled

Major Depression1 trial

A Study of Infliximab for Treatment Resistant Major Depression

Completed·EEmory University·Phase 4·NCT00463580·60 enrolled

COVID-191 trial

Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial

Unknown status·SSunnybrook Health Sciences Centre·Phase 3·NCT04330690·2,900 enrolled

Toxic Epidermal Necrolysis1 trial

Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)

Withdrawn·MMassachusetts Eye and Ear Infirmary·Phase 1/2·NCT01256489

Chronic Granulomatous Disease1 trial

Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00325078·40 enrolled

Induction Therapy1 trial

Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT03371095·53 enrolled

Non-Small Cell Lung Cancer1 trial

Docetaxel With or Without Infliximab in Treating Weight Loss, Loss of Appetite, and Fatigue in Patients With Unresectable Non-Small Cell Lung Cancer (Infliximab Treatment Discontinued Effective 10/05/05)

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00040885·67 enrolled

Eosinophilic Esophagitis1 trial

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

Completed·SSwiss EE Study Group·Phase 2·NCT00523354

Arthritis1 trial

Seronegative Oligoarthritis of the Knee Study (SOKS)

Terminated·UUniversity of Leeds·Phase 2·NCT01216631·1 enrolled

Pemphigus Vulgaris1 trial

Use of Infliximab for the Treatment of Pemphigus Vulgaris

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00283712·20 enrolled

Atopic Dermatitis1 trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Crohn's Disease (CD)1 trial

A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01190839·297 enrolled

Cognitive Dysfunction1 trial

Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

Recruiting·MMassachusetts General Hospital·Phase 2·NCT06136546·100 enrolled

TED1 trial

Remicade Safety Line (Study P03236)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.··NCT00748826·576 enrolled

Depression1 trial

12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression

Completed·UUniversity Health Network, Toronto·Phase 2·NCT02363738·60 enrolled

Hematopoietic Stem Cell Transplantation1 trial

Infliximab for the Prevention of Graft-versus-Host Disease Following Allogenic Hematopoietic Stem Cell Transplantation

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT00201799·19 enrolled

Takayasu arteritis1 trial

Multicentre, Randomized, Prospective Trial Evaluating the Efficacy and Safety of Infliximab to Tocilizumab in Refractory or Relapsing Takayasu Arteritis

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT04564001·50 enrolled

Islet Transplantation1 trial

Islet Transplantation Using Campath-1H and Infliximab Induction

Completed·UUniversity of Alberta·Phase 2·NCT00175266·12 enrolled

Schizophrenia1 trial

Anti-Inflammatory Challenge in Schizophrenia

Recruiting·EEmory University·Phase 4·NCT05823532·20 enrolled

Immunosuppression1 trial

Combined Immunosuppression for Pediatric Crohn's Disease

Recruiting·—·Phase 4·NCT05043870·128 enrolled

Intravenous1 trial

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

Recruiting·BBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZW·Phase 4·NCT06113913·275 enrolled

Scleritis1 trial

Cyclophosphamide vs. Infliximab for Refractory Idiopathic Scleritis (CIRIS)

Withdrawn·HHospices Civils de Lyon·Phase 3·NCT03088293

Melanoma1 trial

Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04407247·47 enrolled

Kidney Transplant1 trial

Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02495077·290 enrolled

Polymyalgia Rheumatica1 trial

Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica

Unknown status·HHospital Universitario Marqués de Valdecilla·Phase 3·NCT01423591·23 enrolled

Complication1 trial

Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT03819296·800 enrolled

Efficacy1 trial

Predictability Studies on the Efficacy of TNF-α Inhibitors in Chinese RA From "Real World"

Unknown status·FFen Li·Phase 4·NCT02878161·240 enrolled

Uveitic Macular Edema1 trial

Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Uveitic Macular Edema

Withdrawn·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT00958906·10 enrolled

Penetrating Keratoplasty1 trial

Topical Infliximab in Eyes With Penetrating Keratoplasty

Recruiting·—·Phase 1/2·NCT05180994·50 enrolled

Unspecified2 trials

Clinical and Molecular Phenotyping in IBD

Completed·UUniversity Hospital Schleswig-Holstein·N/A·NCT02694588·90 enrolled

A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)

Completed· Merck & Co. logo

Merck & Co.··NCT00741104·363 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 24, 1998

INFLIXIMAB

BLA BLA103772

Apr 21, 2017

RENFLEXIS

BLA BLA761054

Sources

References

[1]
ClinicalTrials.gov — 310 trial records for Infliximab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Remicade drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Infliximab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Infliximab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA761054). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: TNF-Alpha Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: OOrganon and Co

Remicade

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Rheumatoid Arthritis30 trials

Crohn's Disease17 trials

Ulcerative Colitis17 trials

Psoriasis15 trials

Infliximab14 trials

Inflammatory Bowel Disease12 trials

Ankylosing Spondylitis10 trials

Efficacy and Safety7 trials

Kawasaki Disease5 trials

Psoriatic Arthritis4 trials

Colitis4 trials

Safety and Efficacy3 trials

Cohort Study3 trials

Acute Graft Versus Host Disease2 trials

Sarcoidosis2 trials

Metastatic Melanoma2 trials

Diabetic Macular Edema2 trials

Inflammation2 trials

Ovarian Reserve1 trial

Diarrhea1 trial

Pancreatic Cancer1 trial

Hidradenitis Suppurativa1 trial

Platelet Function1 trial

Polyarticular Juvenile Idiopathic Arthritis1 trial

Small Bowel Crohn's Disease1 trial

Treatment1 trial

Randomized Controlled Trial1 trial

AIN1 trial

Methotrexate1 trial

Prognosis1 trial

Perianal Crohn's Disease1 trial

Ischemia1 trial

Autoimmune Disease1 trial

Adalimumab1 trial

Moderate to Severe Crohn's Disease1 trial

Inflammatory Disease1 trial

Hepatitis C1 trial

Major Depression1 trial

COVID-191 trial

Toxic Epidermal Necrolysis1 trial

Chronic Granulomatous Disease1 trial

Induction Therapy1 trial

Non-Small Cell Lung Cancer1 trial

Eosinophilic Esophagitis1 trial

Arthritis1 trial

Pemphigus Vulgaris1 trial

Atopic Dermatitis1 trial

Crohn's Disease (CD)1 trial

Cognitive Dysfunction1 trial

TED1 trial

Depression1 trial

Hematopoietic Stem Cell Transplantation1 trial

Takayasu arteritis1 trial

Islet Transplantation1 trial

Schizophrenia1 trial

Immunosuppression1 trial

Intravenous1 trial

Scleritis1 trial

Melanoma1 trial

Kidney Transplant1 trial

Polymyalgia Rheumatica1 trial

Complication1 trial

Efficacy1 trial

Uveitic Macular Edema1 trial

Penetrating Keratoplasty1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News