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

Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice

Completed

Conditions: Plaque Psoriasis
Ankylosing Spondylitis
Crohn´s Disease
Psoriatic Arthritis
Ulcerative Colitis
Rheumatoid Arthritis

Interventions: Drug: Adalimumab

First Posted Date: 2013-01-16

Last Posted Date: 2019-01-28

Lead Sponsor: AbbVie

Target Recruit Count: 96

Registration Number: NCT01768858

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

Phase 3

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: Etanercept
Drug: Sarilumab
Drug: Adalimumab
Drug: Methotrexate
Drug: Placebo (for etanercept)
Drug: Placebo (for sarilumab)

First Posted Date: 2013-01-10

Last Posted Date: 2017-07-27

Lead Sponsor: Sanofi

Target Recruit Count: 776

Registration Number: NCT01764997

Locations: 🇺🇸
Investigational Site Number 840203, Washington, D.C., District of Columbia, United States
🇦🇷
Investigational Site Number 032009, Zarate, Argentina
🇨🇱
Investigational Site Number 152018, Santiago, Chile

and more 254 locations

Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Adalimumab

First Posted Date: 2012-11-29

Last Posted Date: 2019-07-02

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Target Recruit Count: 346

Registration Number: NCT01736189

Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC)

Phase 2

Terminated

Conditions: Ulcerative Colitis

Interventions: Drug: MTX 25
Drug: Adalimumab
Drug: MTX 12.5

First Posted Date: 2012-10-29

Last Posted Date: 2021-06-23

Lead Sponsor: Alimentiv Inc.

Target Recruit Count: 22

Registration Number: NCT01716039

A Study in Moderate to Severe Rheumatoid Arthritis

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Adalimumab
Drug: Methotrexate
Drug: Baricitinib
Drug: Adalimumab Placebo
Drug: Baricitinib Placebo

First Posted Date: 2012-10-19

Last Posted Date: 2019-09-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1307

Registration Number: NCT01710358

Locations: 🇺🇸
Metroplex Clinical Research Center, Dallas, Texas, United States
🇺🇸
The Seattle Arthritis Clinic, Seattle, Washington, United States
🇺🇸
Valley Arthritis Care, LLC, Phoenix, Arizona, United States

and more 45 locations

Swiss Dermatology Network of Targeted Therapies (SDNTT)

Recruiting

Conditions: Psoriasis

Interventions: Biological: Adalimumab
Biological: Etanercept
Biological: Infliximab
Biological: Ustekinumab
Drug: Cyclosporine A
Drug: Fumaric acids
Drug: Other anti-psoriatic systemic treatments
Drug: Methotrexate

First Posted Date: 2012-10-15

Last Posted Date: 2024-11-29

Lead Sponsor: Swiss Dermatology Network for Targeted Therapies

Target Recruit Count: 1121

Registration Number: NCT01706692

Locations: 🇨🇭
Aarau Cantonal Hospital, Aarau, Switzerland
🇨🇭
Inselspital - Bern University Hospital, Bern, Switzerland
🇨🇭
Basel University Hospital, Basel, Switzerland

and more 3 locations

A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

Phase 3

Completed

Conditions: Psoriasis, Arthritic

Interventions: Drug: Placebo
Drug: Ixekizumab
Drug: Adalimumab

First Posted Date: 2012-09-27

Last Posted Date: 2019-01-08

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 417

Registration Number: NCT01695239

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Liverpool, United Kingdom