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

Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis

Phase 2

Completed

Conditions: Uveitis

Interventions: Drug: Adalimumab

First Posted Date: 2007-09-06

Last Posted Date: 2012-04-11

Lead Sponsor: Oregon Health and Science University

Target Recruit Count: 31

Registration Number: NCT00525902

Locations: 🇺🇸
Oregon Health & Science University, Portland, Oregon, United States

Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas

Phase 4

Completed

Conditions: Crohn Disease
Rectal Fistula

Interventions: Procedure: EUA with seton placement if necessary
Drug: adalimumab
Procedure: EUS

First Posted Date: 2007-08-16

Last Posted Date: 2017-04-21

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 21

Registration Number: NCT00517296

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

Medical Treatment of Colitis in Patients With Hermansky-Pudlak Syndrome

Phase 2

Withdrawn

Conditions: Hermanski-Pudlak Syndrome
Colitis
Cytokines
Lymphocytes
Drug Evaluation

Interventions: Drug: Corticosteroids
Drug: Tacrolimus
Drug: Mesalamine
Drug: 6-Mercaptopurine
Drug: Infliximab
Drug: Adalimumab

First Posted Date: 2007-08-10

Last Posted Date: 2017-07-02

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Registration Number: NCT00514982

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)

Not Applicable

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: adalimumab

First Posted Date: 2007-07-06

Last Posted Date: 2008-12-05

Lead Sponsor: University Hospital, Tours

Target Recruit Count: 8

Registration Number: NCT00497614

Locations: 🇫🇷
University Hospital of Tours, Tours, France

Danish Multicenter Study of Adalimumab in Spondyloarthritis

Phase 4

Conditions: Spondyloarthritis

Interventions: Drug: Placebo
Drug: Adalimumab

First Posted Date: 2007-05-24

Last Posted Date: 2012-03-28

Lead Sponsor: Glostrup University Hospital, Copenhagen

Target Recruit Count: 52

Registration Number: NCT00477893

Locations: 🇩🇰
Department of Rheumatology, Vejle Hospital, Vejle, Denmark
🇩🇰
Department of Radiology, Aabenraa Hospital, Aabenraa, Denmark
🇩🇰
Department of Radiology, Herlev University Hospital, Copenhagen, Denmark

and more 10 locations