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
-

Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate

First Posted Date
2015-03-19
Last Posted Date
2019-02-05
Lead Sponsor
Takeda
Target Recruit Count
7
Registration Number
NCT02393378

Treatments Against RA and Effect on FDG-PET/CT

First Posted Date
2015-02-27
Last Posted Date
2022-10-26
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
159
Registration Number
NCT02374021
Locations
🇺🇸

IRIS Research and Development, Plantation, Florida, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

and more 28 locations

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

First Posted Date
2015-01-07
Last Posted Date
2022-03-28
Lead Sponsor
Sanofi
Target Recruit Count
369
Registration Number
NCT02332590
Locations
🇺🇸

Investigational Site Number 840403, Saint Petersburg, Florida, United States

🇺🇸

Investigational Site Number 840229, Coral Gables, Florida, United States

🇺🇸

Investigational Site Number 840140, Tampa, Florida, United States

and more 83 locations

Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients

Completed
Conditions
Interventions
First Posted Date
2015-01-07
Last Posted Date
2019-01-15
Lead Sponsor
AbbVie
Target Recruit Count
201
Registration Number
NCT02333383

Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

First Posted Date
2015-01-01
Last Posted Date
2017-10-13
Lead Sponsor
University Hospitals Cleveland Medical Center
Target Recruit Count
26
Registration Number
NCT02330380
Locations
🇺🇸

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial

Phase 4
Completed
Conditions
Interventions
First Posted Date
2014-10-03
Last Posted Date
2021-09-28
Lead Sponsor
Schneider Children's Medical Center, Israel
Target Recruit Count
82
Registration Number
NCT02256462
Locations
🇮🇱

Schneider Children's Hospital, Petach Tikva, Israel

Effect of Anti-Inflammatory Agents on Biological Responses to Endotoxin Inhalation in Healthy Subjects

Early Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-09-30
Last Posted Date
2014-09-30
Lead Sponsor
Brugmann University Hospital
Target Recruit Count
51
Registration Number
NCT02252809

Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-07-22
Last Posted Date
2018-03-19
Lead Sponsor
AbbVie
Target Recruit Count
46
Registration Number
NCT02196701
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