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

Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)

Not Applicable

Terminated

Conditions: ULCERATIVE COLITIS

Interventions: Drug: VEDOLIZUMAB
Drug: ADALIMUMAB

First Posted Date: 2016-08-25

Last Posted Date: 2023-02-17

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 19

Registration Number: NCT02878083

Locations: 🇫🇷
Chu Angers, Angers, France
🇫🇷
Chd Vendee, La Roche Sur Yon, France
🇫🇷
Chu Nantes, Nantes, France

and more 1 locations

Reduce Risk for Crohn's Disease Patients

Phase 4

Conditions: Crohn's Disease

Interventions: Drug: Methotrexate
Drug: Azathioprine / 6 Mercaptopurine
Drug: Adalimumab

First Posted Date: 2016-08-02

Last Posted Date: 2020-04-16

Lead Sponsor: PIBD-Net

Target Recruit Count: 312

Registration Number: NCT02852694

Locations: 🇫🇷
Hôpital Necker -Enfants Malades (Service de gastro-enterologie), Paris, France

Treatment Tapering in JIA With Inactive Disease

Phase 3

Completed

Conditions: Juvenile Idiopathic Arthritis

Interventions: Drug: etanercept
Drug: adalimumab
Drug: Abatacept
Drug: Tocilizumab

First Posted Date: 2016-07-21

Last Posted Date: 2021-04-01

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 62

Registration Number: NCT02840175

Locations: 🇫🇷
Necker Children's Hospital, Paris, France

Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: GDC-0853
Drug: Adalimumab
Drug: Folic Acid
Drug: MTX
Drug: Placebo

First Posted Date: 2016-07-14

Last Posted Date: 2020-06-12

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 578

Registration Number: NCT02833350

Locations: 🇺🇸
Pinnacle Research Group; Llc, Central, Anniston, Alabama, United States
🇺🇸
Medvin Clinical Research, Covina, California, United States
🇺🇸
TriWest Research Associates, LLC, El Cajon, California, United States

and more 147 locations

Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically

Phase 4

Completed

Conditions: Hidradenitis Suppurativa (HS)

Interventions: Drug: Placebo
Drug: Adalimumab

First Posted Date: 2016-06-22

Last Posted Date: 2020-05-14

Lead Sponsor: AbbVie

Target Recruit Count: 206

Registration Number: NCT02808975

Locations: 🇺🇸
Beth Israel Deaconess Medical Center /ID# 168438, Boston, Massachusetts, United States
🇧🇪
UZ Gent /ID# 150906, Gent, Oost-Vlaanderen, Belgium
🇨🇦
NewLab Clinical Research Inc. /ID# 151315, St. John's, Newfoundland and Labrador, Canada

and more 52 locations

Triple Combination Therapy in High Risk Crohn's Disease (CD)

Phase 4

Completed

Conditions: Crohn Disease

Interventions: Drug: Vedolizumab
Drug: Adalimumab
Drug: Methotrexate

First Posted Date: 2016-05-06

Last Posted Date: 2023-07-14

Lead Sponsor: Takeda

Target Recruit Count: 55

Registration Number: NCT02764762

Locations: 🇺🇸
Cotton O'Neil Clinical Research, Topeka, Kansas, United States
🇺🇸
University of Mississippi Medical Center, Jackson, Mississippi, United States
🇨🇦
PerCuro Clinical Research Ltd, Victoria, British Columbia, Canada

and more 29 locations

Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

Phase 2

Recruiting

Conditions: Uveitis
Non-Infectious Uveitis

Interventions: Drug: Adalimumab

First Posted Date: 2016-03-11

Last Posted Date: 2023-07-21

Lead Sponsor: American University of Beirut Medical Center

Target Recruit Count: 32

Registration Number: NCT02706704

Locations: 🇱🇧
American University of Beirut Medical Center, Beirut, Lebanon

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

Phase 3

Completed

Conditions: Spondyloarthritis

Interventions: Drug: Ixekizumab
Drug: Placebo
Drug: Adalimumab

First Posted Date: 2016-03-02

Last Posted Date: 2019-11-19

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 341

Registration Number: NCT02696785

Locations: 🇺🇸
Klein and Associates MD, PA, Hagerstown, Maryland, United States
🇺🇸
Marietta Rheumatology, Marietta, Georgia, United States
🇺🇸
Sarasota Arthritis Center, Sarasota, Florida, United States

and more 17 locations

Adalimumab in Alleviating Inflammation in Patients With Axial Spondyloarthritis

Phase 4

Conditions: Ankylosing Spondyloarthritis

Interventions: Other: PET/CT imaging
Drug: Adalimumab

First Posted Date: 2015-12-18

Last Posted Date: 2017-02-23

Lead Sponsor: University of Helsinki

Target Recruit Count: 60

Registration Number: NCT02634541

Locations: 🇫🇮
Helsinki University Central Hospital, Helsinki, Finland
🇫🇮
Päijät-Häme Central Hospital, Lahti, Finland

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

Phase 3

Active, not recruiting

Conditions: Rheumatoid Arthritis

Interventions: Drug: Adalimumab
Drug: Placebo for Adalimumab
Drug: Placebo for Upadacitinib
Drug: Upadacitinib

First Posted Date: 2015-12-14

Last Posted Date: 2024-06-18

Lead Sponsor: AbbVie

Target Recruit Count: 1629

Registration Number: NCT02629159

Locations: 🇺🇸
Precision Research Org, LLC /ID# 143092, Miami Lakes, Florida, United States
🇺🇸
DM Clinical Research /ID# 151357, Tomball, Texas, United States
🇿🇦
Arthritis Clinical Research Tr /ID# 144874, Cape Town, Western Cape, South Africa

and more 367 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy