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

PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)

Phase 1

Completed

Conditions: Phase 1

Interventions: Drug: Adalimumab

First Posted Date: 2019-06-12

Last Posted Date: 2022-05-04

Lead Sponsor: Alvotech Swiss AG

Target Recruit Count: 207

Registration Number: NCT03983876

Locations: 🇳🇿
Auckland Clinical Studies, Auckland, New Zealand
🇳🇿
Christchurch Clinical Studies Trust Limited, Christchurch, Chistchurch, New Zealand

Control Crohn Safe Trial

Phase 4

Recruiting

Conditions: Inflammatory Bowel Diseases
Crohn Disease

Interventions: Drug: standard step-up care
Drug: Adalimumab

First Posted Date: 2019-04-17

Last Posted Date: 2022-09-07

Lead Sponsor: Maastricht University Medical Center

Target Recruit Count: 158

Registration Number: NCT03917303

Locations: 🇳🇱
Maastricht University Medical Centre+, Maastricht, Netherlands
🇳🇱
Zuyderland Medical Center, Sittard, Netherlands
🇳🇱
VieCuri, Venlo, Netherlands

and more 3 locations

A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Phase 3

Completed

Conditions: Psoriatic Arthritis

Interventions: Drug: Bimekizumab
Drug: Adalimumab
Other: Placebo

First Posted Date: 2019-03-29

Last Posted Date: 2024-10-23

Lead Sponsor: UCB Biopharma SRL

Target Recruit Count: 852

Registration Number: NCT03895203

Locations: 🇩🇪
Pa0010 40026, Ratingen, Germany
🇭🇺
Pa0010 40030, Eger, Hungary
🇮🇹
Pa0010 40084, Catania, Italy

and more 133 locations

Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab)

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Adalimumab

First Posted Date: 2019-02-21

Last Posted Date: 2022-05-04

Lead Sponsor: Alvotech Swiss AG

Target Recruit Count: 390

Registration Number: NCT03849313

Locations: 🇦🇺
Scientia Clinical Research, Sydney, New South Wales, Australia
🇳🇿
Auckland Clinical Studies, Auckland, New Zealand
🇳🇿
Christchurch Clinical Studies Trust Limited, Christchurch, Chistchurch, New Zealand

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Phase 2

Completed

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: Placebo for ABBV-3373
Drug: ABBV-3373
Drug: Adalimumab
Drug: Placebo for adalimumab

First Posted Date: 2019-01-30

Last Posted Date: 2021-07-19

Lead Sponsor: AbbVie

Target Recruit Count: 48

Registration Number: NCT03823391

Locations: 🇺🇸
PCCR Solution /ID# 215457, Colleyville, Texas, United States
🇺🇸
C.V. Mehta MD, Med Corporation /ID# 213068, Hemet, California, United States
🇺🇸
Robin K. Dore MD, Inc /ID# 213045, Tustin, California, United States

and more 27 locations

Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial

Phase 4

Recruiting

Conditions: Psoriatic Arthritis

Interventions: Drug: Methotrexate
Drug: Sulfasalazine
Drug: Adalimumab
Drug: Leflunomide

First Posted Date: 2018-11-14

Last Posted Date: 2023-11-29

Lead Sponsor: University of Oxford

Target Recruit Count: 315

Registration Number: NCT03739853

Locations: 🇬🇧
Oxford University Hospitals NHS Trust, Oxford, Oxfordshire, United Kingdom

A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)

Phase 4

Completed

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: methotrexate
Drug: tacrolimus
Biological: adalimumab
Biological: tocilizumab
Biological: abatacept

First Posted Date: 2018-11-09

Last Posted Date: 2024-10-31

Lead Sponsor: Astellas Pharma Korea, Inc.

Target Recruit Count: 21

Registration Number: NCT03737708

Locations: 🇰🇷
Site KR82003, Daegu, Korea, Republic of
🇰🇷
Site KR82007, Daegu, Korea, Republic of
🇰🇷
Site KR82002, Incheon, Korea, Republic of

and more 7 locations

One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study

Completed

Conditions: Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Crohn's Disease
Colitis, Ulcerative

Interventions: Drug: Adalimumab
Drug: Infliximab

First Posted Date: 2018-09-10

Last Posted Date: 2022-10-18

Lead Sponsor: Biogen

Target Recruit Count: 2274

Registration Number: NCT03662919

Locations: 🇫🇷
Research Site, Toulon, Provence-Alpes-Côte d'Azur, France
🇫🇷
Research Site 2, La Rochelle, Nouvelle-Aquitaine, France
🇫🇷
Research Site 3, Paris, Ile De France, France

and more 8 locations