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

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Phase 3

Completed

Conditions: Psoriatic Arthritis

Interventions: Drug: Upadacitinib
Drug: Adalimumab
Drug: Placebo to Upadacitinib
Drug: Placebo to Adalimumab

First Posted Date: 2017-04-07

Last Posted Date: 2024-10-01

Lead Sponsor: AbbVie

Target Recruit Count: 1705

Registration Number: NCT03104400

Locations: 🇺🇸
Great Lakes Clinical Trials /ID# 163435, Chicago, Illinois, United States
🇨🇳
1st Aff Hosp of Bengbu Medical College /ID# 201021, Bengbu, Anhui, China
🇨🇳
The First Affiliated Hospital of Shantou University Medical College /ID# 203371, Shantou, Guangdong, China

and more 342 locations

Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation

Phase 4

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: Tocilizumab
Drug: Etanercept
Drug: Infliximab
Drug: Adalimumab
Drug: Golimumab
Drug: Certolizumab Pegol

First Posted Date: 2017-04-04

Last Posted Date: 2022-09-19

Lead Sponsor: Mario Negri Institute for Pharmacological Research

Target Recruit Count: 208

Registration Number: NCT03100253

Locations: 🇮🇹
Policlinico Sant'Orsola Malpighi, Bologna, Italy
🇮🇹
Azienda Consorziale Ospedaliera Policlinico, Bari, Italy
🇮🇹
Azienda Socio Sanitaria Territoriale - Papa Giovanni XXIII, Bergamo, Italy

and more 19 locations

Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD

Phase 4

Withdrawn

Conditions: Crohn Disease
Ulcerative Colitis

Interventions: Drug: Adalimumab

First Posted Date: 2017-02-23

Last Posted Date: 2020-01-18

Lead Sponsor: McMaster University

Registration Number: NCT03059849

Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab

Completed

Conditions: Arthritis,Rheumatoid

Interventions: Drug: Tocilizumab
Drug: Adalimumab

First Posted Date: 2016-11-15

Last Posted Date: 2018-11-14

Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Target Recruit Count: 35

Registration Number: NCT02963402

Locations: 🇪🇸
Insitut de Recerca Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Randomized Trial Comparing Efficacy of Adalimumab, Anakinra and Tocilizumab in Non-infectious Refractory Uveitis

Phase 2

Completed

Conditions: Uveitis
Biotherapy

Interventions: Drug: Adalimumab
Drug: Tocilizumab
Drug: Anakinra

First Posted Date: 2016-10-11

Last Posted Date: 2024-06-25

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 112

Registration Number: NCT02929251

Locations: 🇫🇷
Hopital Pellegrin, Bordeaux, France
🇫🇷
Hopital Saint André - Médecine interne, Bordeaux, France
🇫🇷
HCL - Hôpital de la Croix Rousse - Ophtalmologie, Lyon, France

and more 24 locations

A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: DMB-3113
Drug: Adalimumab

First Posted Date: 2016-10-07

Last Posted Date: 2017-08-22

Lead Sponsor: Meiji Seika Pharma Co., Ltd.

Target Recruit Count: 180

Registration Number: NCT02927353

Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection
Drug: adalimumab

First Posted Date: 2016-09-23

Last Posted Date: 2019-03-07

Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Target Recruit Count: 183

Registration Number: NCT02912247

Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa

Phase 3

Completed

Conditions: Hidradenitis Suppurativa

Interventions: Drug: adalimumab

First Posted Date: 2016-09-19

Last Posted Date: 2020-05-12

Lead Sponsor: AbbVie

Target Recruit Count: 15

Registration Number: NCT02904902

Locations: 🇯🇵
Fukuoka University Hospital /ID# 151350, Fukuoka, Japan
🇯🇵
Takagi Dermatological Clinic /ID# 151906, Obihiro, Hokkaido, Japan
🇯🇵
Kurume University Hospital /ID# 152579, Kurume-shi, Fukuoka, Japan

and more 5 locations