Adalimumab

Generic Name: Adalimumab

Brand Names: Amjevita, Cyltezo, Humira, Hyrimoz, Yusimry, Hulio, Hefiya, Libmyris, Imraldi, Amsparity, Idacio, Hukyndra, Amgevita, Yuflyma

Drug Type: Biotech

Chemical Formula: -

CAS Number: 331731-18-1

Unique Ingredient Identifier: FYS6T7F842

Background: Adalimumab is a subcutaneously administered biological disease modifier for the treatment of rheumatoid arthritis and other chronic debilitating diseases mediated by tumor necrosis factor. It was originally launched by Abbvie in the U.S. and approved in 2002 by the FDA. This drug is frequently known as Humira. It is produced by recombinant DNA technology using a mammalian cell expression system. This drug is available in a prefilled syringe form and convenient pen form for subcutaneous self-administered doses.

Several biosimilars to adalimumab. Adalimumab-atto was the first adalimumab biosimilar approved by the FDA in 2016. Adalimumab-adaz was approved by the FDA on October 31, 2018. Other biosimilars include adalimumab-fkjp, which was approved in July 2022, and adalimumab-bwwd, which was approved in August 2022. A biosimilar marketed as Hyrimoz, a high-concentration formulation of adalimumab, is also available.

Indication: Adalimumab is indicated for the following conditions:

Adalimumab has also been used off-label to treat Pyoderma gangrenosum.

Associated Conditions: Ankylosing Spondylitis (AS), Hidradenitis Suppurativa (HS), Moderate to Severe Chronic Plaque Psoriasis, Moderate to Severe Rheumatoid Arthritis, Moderately to Severely Active Crohn's Disease, Moderately to Severely Active Ulcerative Colitis, Non-infectious Intermediate, Posterior and Panuveitis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Pyoderma Gangrenosum

Associated Therapies: -

Clinical Trials

Diabetes Islet Preservation Immune Treatment

Phase 1

Withdrawn

Conditions: Autoimmune Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia

Interventions: Drug: Anti-Thymocyte Globulin (ATG)
Other: ATG Placebo
Other: IL-2 Placebo
Drug: Interleukin 2
Other: Adalimumab Placebo
Drug: Exenatide
Other: Exenatide Placebo
Drug: Adalimumab

First Posted Date: 2015-10-26

Last Posted Date: 2024-06-06

Lead Sponsor: Camillo Ricordi and Jay Skyler

Registration Number: NCT02586831

Locations: 🇺🇸
Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, Florida, United States

Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis

Phase 4

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Abatacept
Drug: Methotrexate
Drug: Adalimumab

First Posted Date: 2015-09-23

Last Posted Date: 2020-09-03

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 80

Registration Number: NCT02557100

Locations: 🇺🇸
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
🇲🇽
Clinica de Investigacion en Reumatologia y Obesidad S.C., Guadalajara, Jalisco, Mexico
🇲🇽
Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V., Mexico D.F., Mexico

and more 24 locations

Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease

Not Applicable

Completed

Conditions: Crohn Disease

Interventions: Dietary Supplement: FOS
Drug: Adalimumab

First Posted Date: 2015-09-03

Last Posted Date: 2018-01-31

Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Target Recruit Count: 38

Registration Number: NCT02539849

Locations: 🇪🇸
Hospital La Princesa, Madrid, Spain
🇪🇸
Hospital de Bellvitge, Hospitalet del Llobregat, Barcelona, Spain
🇪🇸
Hospital de Santiago, Santiago de Compostela, A Coruña, Spain

and more 2 locations

Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

Phase 3

Completed

Conditions: Generalized Pustular Psoriasis (GPP)
Adalimumab
Japanese

Interventions: Drug: Adalimumab

First Posted Date: 2015-08-26

Last Posted Date: 2019-01-14

Lead Sponsor: AbbVie

Target Recruit Count: 10

Registration Number: NCT02533375

A Trial of Adalimumab Combined to Chemotherapy and Radiotherapy in Patients With Anaplastic Thyroid Cancers

Phase 1

Withdrawn

Conditions: Anaplastic Thyroid Cancers

Interventions: Drug: Adalimumab

First Posted Date: 2015-08-06

Last Posted Date: 2016-01-26

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Registration Number: NCT02516774

Locations: 🇫🇷
Gustave Roussy Cancer Campus Grand Paris, Villejuif, Val de Marne, France

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

Phase 3

Completed

Conditions: Colitis, Ulcerative

Interventions: Drug: Vedolizumab
Drug: Adalimumab
Drug: Adalimumab placebo
Drug: Vedolizumab placebo

First Posted Date: 2015-07-14

Last Posted Date: 2020-01-28

Lead Sponsor: Takeda

Target Recruit Count: 771

Registration Number: NCT02497469

Locations: 🇺🇸
Chevy Chase Clinical Research, Chevy Chase, Maryland, United States
🇺🇸
Texas Digestive Disease Consultants - Dallas, Dallas, Texas, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States

and more 326 locations

Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) α Agent's Efficacy in Ankylosing Spondylitis Patients

Phase 4

Completed

Conditions: Ankylosing Spondylitis

Interventions: Drug: Adalimumab

First Posted Date: 2015-07-08

Last Posted Date: 2020-11-03

Lead Sponsor: Universidade Nova de Lisboa

Target Recruit Count: 69

Registration Number: NCT02492217

Locations: 🇵🇹
Faculdade de Ciências Médicas da Universidade Nova de Lisboa, Lisbon, Portugal

Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis

Phase 3

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: CHS-1420
Drug: Adalimumab

First Posted Date: 2015-07-02

Last Posted Date: 2020-04-08

Lead Sponsor: Coherus Biosciences, Inc.

Target Recruit Count: 545

Registration Number: NCT02489227

Locations: 🇵🇱
Centrum Badań Kliniccznych, Gdańsk, Poland
🇵🇱
Niepubliczny Zaklad Opieki Zdrowtnej "NASZ LEKARZ", Toruń, Poland
🇿🇦
Medicross Pretoria West 1st Floor, Pretoria West, Pretoria, South Africa

and more 94 locations