Clinical Trials

Across diverse recruitment statuses, numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate TNF-α-targeted therapeutic strategies for chronic inflammatory and autoimmune conditions. Supported by academic institutions, hospital networks, and commercial sponsors, these studies encompass conditions such as rheumatoid arthritis, periodontitis, type 2 diabetes, low back pain, and recurrent unexplained implantation failure. Notably, several clinical trials involve phase 3 evaluations of certolizumab for implantation failure and phase 4 investigations into metabolic pathways in type 2 diabetes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05930613 RECRUITING
Recurrent Unexplained Implantation Failure
Assistance Publique - Hôpitaux de Paris
 2023-11-30 PHASE3
NCT07176754 ACTIVE_NOT_RECRUITING
Cardiac Arrest (CA); Post Cardiac Arrest Syndrome
Peking University Third Hospital
 2025-10-01
NCT07344428 NOT_YET_RECRUITING
Crohn Disease
Sixth Affiliated Hospital, Sun Yat-sen University
 2026-08-01
NCT06812988 ACTIVE_NOT_RECRUITING
Type 1 Diabetes Mellitus
Sanofi
 2025-02-28 PHASE2
NCT07750392 RECRUITING
Myofacial Pain Syndrome
Udayana University
 2026-07-30
NCT04066348 RECRUITING
Tinnitus, Noise Induced
Wayne State University
 2022-07-01 PHASE2
NCT07475065 NOT_YET_RECRUITING
Diabetic Polyneuropathy; Peripheral Nervous System Diseases; Peripheral Neuropathy; Diabetes Mellitus
Universitas Sebelas Maret
 2026-03-01 PHASE2; PHASE3
NCT07509411 COMPLETED
Endometriosis
Benha University
 2025-08-15 PHASE2
NCT04378621 UNKNOWN
Rheumatoid Arthritis; Pain; Fatigue; Cognitive Decline; Depression; Brain Diseases; Hand Rheumatism
Vastra Gotaland Region
 2020-10-01
NCT07525531 COMPLETED
Periodontitis
Ondokuz Mayıs University
 2024-04-20
NCT05925166 COMPLETED
Acute Gout
Lihua Duan
 2020-09-01
NCT06818045 COMPLETED
Peridontal Disease; Rheumatic Arthritis
Hatice Yemenoğlu
 2024-03-01
NCT07731412 COMPLETED
Obesity; Periodontitis
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
 2022-12-01
NCT06585982 RECRUITING
Fatty Liver Disease
Universitas Diponegoro
 2024-03-04
NCT07071233 COMPLETED
Systemic Lupus Erythematosus (SLE)
Universitas Sriwijaya
 2024-09-01
NCT06912035 COMPLETED
Uncontrolled Diabetes; Diabetes Mellitus Type 2
Universitas Sriwijaya
 2024-06-21 PHASE2; PHASE3
NCT06971770 COMPLETED
Periodontal Diseases
Izmir Katip Celebi University
 2024-04-01
NCT06175338 ACTIVE_NOT_RECRUITING
Rheumatoid Arthritis
Mabscale, LLC
 2023-06-14 PHASE1
NCT06539039 COMPLETED
Periodontitis Generalized
Ain Shams University
 2024-03-01
NCT06662721 COMPLETED
Takayasu Arteritis
Liu Tian
 2023-04-03 PHASE2
NCT07677462 COMPLETED
Primary Dysmenorrhea (PD)
Universitas Sriwijaya
 2023-03-01
NCT05155592 UNKNOWN
Uveitis; Adalimumab
Dan Liang
 2021-01-01 PHASE2
NCT04004910 UNKNOWN
Advanced Breast Cancer
Immunicom Inc
 2019-05-31 PHASE1; PHASE2
NCT06786910 COMPLETED
Inflammation; Interleukin-1beta; TNF-α; Cytokine Levels; BMI; Chronic Inflammatory Diseases; Dysbiosis; Overweight (BMI > 25)
Mucosa Innovations, S.L.
 2022-06-13
NCT05333133 COMPLETED
Failure to Thrive; Infection, Bacterial; Growth Faltering
Universitas Airlangga
 2021-10-04
NCT04113317 COMPLETED
Liver Cirrhosis; Severe Malnutrition; PELD; Undernutrition
Fakultas Kedokteran Universitas Indonesia
 2020-01-01 PHASE3
NCT05179070 UNKNOWN
Heart Failure With Reduced Ejection Fraction HFrEF
Universitas Sebelas Maret
 2021-09-10 PHASE4
NCT05253599 COMPLETED
Low Back Pain
Prince Sattam Bin Abdulaziz University
 2019-11-01
NCT03760003 COMPLETED
Ulcerative Colitis
Abivax S.A.
 2019-08-13 PHASE2
NCT05336006 COMPLETED
Pediatric Obesity; COVID-19
Prince Sattam Bin Abdulaziz University
 2020-03-10
NCT04851002 COMPLETED
Edentulous Jaw; Bone Loss, Alveolar; Resorption, Bone
Muhammet Atilgan
 2019-10-03
NCT04789525 COMPLETED
Obesity, Childhood
Cairo University
 2020-03-10
NCT05862311 COMPLETED
Periodontal Diseases
Necmettin Erbakan University
 2020-03-12
NCT02508012 COMPLETED
Crohn's Disease; Ulcerative Colitis
University Hospital, Montpellier
 2015-09-24
NCT06441526 COMPLETED
Perianal Fistula; Crohn Disease
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2013-09-14 PHASE3
NCT03293784 COMPLETED
Melanoma
Institut Claudius Regaud
 2017-10-16 PHASE1
NCT04098562 UNKNOWN
Diabetic Foot Ulcer
Fakultas Kedokteran Universitas Indonesia
 2019-10 PHASE2
NCT04777487 COMPLETED
Periodontal Diseases
Izmir Katip Celebi University
 2019-04-01
NCT02760433 COMPLETED
Rheumatoid Arthritis
R-Pharm International, LLC
 2017-01-25 PHASE3
NCT06703086 COMPLETED
Obesity; Overweight; Berberine
National Polytechnic Institute, Mexico
 2019-01-05
NCT01590966 COMPLETED
Axial and Peripheral Spondyloarthritis; Rheumatoid Arthritis
University Hospital, Ghent
 2012-10-18 PHASE3
NCT02882087 TERMINATED
Moderate and Severe Rheumatoid Arthritis
RemeGen Co., Ltd.
 2015-10 PHASE2
NCT04020315 COMPLETED
Aggressive Periodontitis, Generalized; Periodontal Health
Aydin Adnan Menderes University
 2017-12-01
NCT02492217 COMPLETED
Ankylosing Spondylitis
Universidade Nova de Lisboa
 2015-05 PHASE4
NCT02743390 COMPLETED
Hypertension
University of Campinas, Brazil
 2015-03 PHASE4
NCT04062474 COMPLETED
Spinal Stenosis
Nanjing First Hospital, Nanjing Medical University
 2016-05-15
NCT03186196 COMPLETED
Overweight and Obesity
Federal University of Paraíba
 2016-08-01
NCT02960035 COMPLETED
Spondyloarthropathy
Sun Yat-sen University
 2014-04 PHASE4
NCT02875691 COMPLETED
Autoimmune; Lupus Erythematosus, Systemic
Ahvaz Jundishapur University of Medical Sciences
 2015-09 PHASE2
NCT03074097 COMPLETED
Postoperative Pain
Assiut University
 2015-03-05 PHASE2
NCT02243787 TERMINATED
Plaque Psoriasis
Covagen
 2014-04 PHASE1; PHASE2
NCT01276314 COMPLETED
Drug Hypersensitivity
Chang Gung Memorial Hospital
 2009-01
NCT01709578 COMPLETED
Rheumatoid Arthritis
Sanofi
 2012-10 PHASE3
NCT01350804 COMPLETED
Rheumatoid Arthritis
Novartis Pharmaceuticals
 2011-09 PHASE3
NCT00949039 COMPLETED
Gynaecologic or Digestive Pelvic Cancer
Gustave Roussy, Cancer Campus, Grand Paris
 2009-02 PHASE3
NCT01651936 TERMINATED
Rheumatoid Arthritis
Merck Sharp & Dohme LLC
 2012-08-29 PHASE2
NCT01202773 TERMINATED
Rheumatoid Arthritis
Eli Lilly and Company
 2011-01 PHASE3
NCT01452958 COMPLETED
Inflammation; Glucose Metabolism Disorders
Aarhus University Hospital
 2010-06
NCT02008864 COMPLETED
End Stage Renal Disease; Pruritus
Shiraz University of Medical Sciences
 2011-08
NCT01205503 COMPLETED
Breast Cancer; Non-Hodgkin's Lymphoma
Mara Chambers
 2010-09 PHASE2
NCT01575340 COMPLETED
Colorectal Cancer; Inflammation
Universidade Federal de Santa Catarina
 2011-07
NCT01223196 COMPLETED
Type 2 Diabetes
The University of Texas Health Science Center at San Antonio
 2009-08 PHASE4
NCT01217814 TERMINATED
Rheumatoid Arthritis
Sanofi
 2010-11 PHASE2
NCT01661257 COMPLETED
Crohn's Disease
Samsung Medical Center
 2009-10 PHASE3
NCT00603525 TERMINATED
Arthritis, Rheumatoid
GlaxoSmithKline
 2008-01 PHASE3
NCT00801125 WITHDRAWN
Crohn's Disease
Biogen
 2008-12 PHASE4
NCT00476996 TERMINATED
Rheumatoid Arthritis
Genentech, Inc.
 2007-05-15 PHASE3
NCT02719587 COMPLETED
Chronic Periodontitis
İlker KESKINER
 2009-04 EARLY_PHASE1
NCT02711202 COMPLETED
Kidney Transplantation
Institute for Clinical and Experimental Medicine
 2007-01
NCT00432406 COMPLETED
Psoriatic Arthritis
Chinese University of Hong Kong
 2006-05 PHASE4
NCT01953393 COMPLETED
Diabetes Type 2
Rigshospitalet, Denmark
 2006-04
NCT00231413 COMPLETED
Infections, Papillomavirus
GlaxoSmithKline
 2005-03-04 PHASE2
NCT00448383 COMPLETED
Rheumatoid Arthritis
Abbott
 2002-09 PHASE3
NCT01490047 WITHDRAWN
Solid Tumors; Lymphomas
Ludwig Institute for Cancer Research
 2013-01 PHASE1
NCT00630006 UNKNOWN
Hepatitis C Virus Infection; Chronic Liver Disease
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2007-01
NCT00629668 UNKNOWN
Chronic Liver Disease; Hepatocellular Carcinoma
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2007-01

(data from https://clinicaltrials.gov, updated on 2023-12-11)

Check the TNF-α (31-45), human product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TNF-α (31-45), human binds to cell surface receptors to stimulate downstream NF-κB signaling cascades, thereby promoting the transcription of pro-inflammatory cytokines and modulating apoptotic cell death pathways. This activation of inflammatory cellular processes mediates progressive tissue destruction and systemic immune responses, driving the pathology observed in clinical trial conditions such as rheumatoid arthritis, periodontitis, and chronic inflammatory disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.