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

Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115

Phase 3

Completed

Conditions: Crohn's Disease

Interventions: Drug: Adalimumab

First Posted Date: 2014-07-09

Last Posted Date: 2018-11-14

Lead Sponsor: AbbVie

Target Recruit Count: 252

Registration Number: NCT02185014

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

Phase 3

Completed

Conditions: Ulcerative Colitis

Interventions: Other: Adalimumab Placebo
Drug: Adalimumab
Other: Etrolizumab Placebo
Drug: Etrolizumab

First Posted Date: 2014-06-24

Last Posted Date: 2021-07-23

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 358

Registration Number: NCT02171429

Locations: 🇧🇬
Medical center Medconsult Pleven OOD, Pleven, Bulgaria
🇦🇷
Centro de Investigaciones Medicas Mar Del Plata, Mar del Plata, Argentina
🇧🇬
DCC Sv. Pantaleymon OOD, Pleven, Bulgaria

and more 87 locations

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

Phase 3

Completed

Conditions: Ulcerative Colitis

Interventions: Other: Adalimumab Placebo
Drug: Adalimumab
Other: Etrolizumab Placebo
Drug: Etrolizumab

First Posted Date: 2014-06-16

Last Posted Date: 2021-07-23

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 358

Registration Number: NCT02163759

Locations: 🇵🇱
EMC Instytut Medyczny S.A., Wrocław, Poland
🇵🇱
AppleTreeClinics Sp. z o.o., Łódź, Poland
🇪🇪
Tartu University Hospital, Tartu, Estonia

and more 85 locations

The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) Patients

Phase 3

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: Adalimumab
Drug: Placebo

First Posted Date: 2014-05-29

Last Posted Date: 2017-10-18

Lead Sponsor: Heinrich-Heine University, Duesseldorf

Target Recruit Count: 21

Registration Number: NCT02150473

Locations: 🇩🇪
Universitätsklinikum Düsseldorf, Düsseldorf, NRW, Germany

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

Phase 4

Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Hypertension

Interventions: Drug: Etanercept
Drug: Adalimumab
Drug: Certolizumab
Drug: Infliximab

First Posted Date: 2014-05-07

Last Posted Date: 2014-05-07

Lead Sponsor: Jagiellonian University

Target Recruit Count: 100

Registration Number: NCT02132234

Locations: 🇵🇱
Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński, Krakow, Skarbowa 4, Poland

Clinical Trial Using Humira in Netherton Syndrome

Phase 2

Completed

Conditions: Netherton Syndrome

Interventions: Drug: Adalimumab

First Posted Date: 2014-04-15

Last Posted Date: 2017-10-18

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 11

Registration Number: NCT02113904

Locations: 🇫🇷
Necker Enfants Malades hospital, Paris, France

A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Phase 2

Withdrawn

Conditions: Inflammation
Rheumatoid Arthritis

Interventions: Drug: NNC0109-0012
Drug: Adalimumab
Drug: placebo

First Posted Date: 2014-03-27

Last Posted Date: 2014-08-15

Lead Sponsor: Novo Nordisk A/S

Registration Number: NCT02097264

Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study

Phase 2

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: Fostamatinib
Drug: Adalimumab
Drug: Placebo of Adalimumab
Drug: Placebo of Fostamatinib

First Posted Date: 2014-03-20

Last Posted Date: 2014-06-25

Lead Sponsor: AstraZeneca

Target Recruit Count: 198

Registration Number: NCT02092961

Locations: 🇬🇧
Research Site, Oxford, United Kingdom

Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

Phase 3

Completed

Conditions: Crohn's Disease

Interventions: Drug: Adalimumab
Drug: Placebo

First Posted Date: 2014-02-19

Last Posted Date: 2021-02-18

Lead Sponsor: AbbVie

Target Recruit Count: 514

Registration Number: NCT02065570

Locations: 🇺🇸
Texas Digestive Disease Consultants - Dallas /ID# 138121, Dallas, Texas, United States
🇺🇸
University of Chicago DCAM /ID# 119077, Chicago, Illinois, United States
🇺🇸
Atlanta Gastro Assoc /ID# 119065, Atlanta, Georgia, United States

and more 140 locations

Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

Phase 3

Completed

Conditions: Ulcerative Colitis (UC)

Interventions: Drug: Adalimumab
Other: Placebo

First Posted Date: 2014-02-19

Last Posted Date: 2020-11-23

Lead Sponsor: AbbVie

Target Recruit Count: 952

Registration Number: NCT02065622

Locations: 🇺🇸
Atlanta Gastro Assoc /ID# 122336, Atlanta, Georgia, United States
🇺🇸
Northwestern University Feinberg School of Medicine /ID# 122183, Chicago, Illinois, United States
🇺🇸
University of Pittsburgh MC /ID# 122331, Pittsburgh, Pennsylvania, United States

and more 170 locations

Drug Development Updates

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