MedPath

Golimumab

Generic Name
Golimumab
Brand Names
Simponi
Drug Type
Biotech
CAS Number
476181-74-5
Unique Ingredient Identifier
91X1KLU43E
Background

Golimumab is a human IgG1қ monoclonal antibody derived from immunizing genetically engineered mice with human TNFα. Golimumab binds and inhibits soluble and transmembrane human TNFα. Increased TNFα is associated with chronic inflammation. Thus golimumab is indicated for use in adults (i) as an adjunct to methotrexate treatment in patients with moderate to severe active rheumatoid arthritis (RA), (ii) alone or as an adjunct to methotrexate treatment in patients with active psoriatic arthritis (PsA), (iii) as a single agent in patients with active ankylosing spondylitis (AS), and (iv) as a single agent in patients with moderate to severe ulcerative colitis (UC) who require chronic steroids or have experienced intolerance or only a partial response to previous medications. In the U.S. and Canada, golimumab is marketed under the brand name Simponi®. The FDA label includes a black box warning of serious infections and malignancy. Additionally in children and adolescents taking golimumab, there have been lymphoma and other malignancies observed.

Indication

Used in adults (i) as an adjunct to methotrexate treatment in patients with moderate to severe active rheumatoid arthritis (RA), (ii) in patients 2 years old and above with active psoriatic arthritis (PsA), (iii) as a single agent in patients with active ankylosing spondylitis (AS) or in combination with methotrexate, and (iv) as a single agent in patients with moderate to severe ulcerative colitis (UC) who require chronic steroids or have experienced intolerance or only a partial response to previous medications. It is also indicated (v) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.

Associated Conditions
Active Polyarticular Juvenile Idiopathic Arthritis (pJIA), Severe Ulcerative Colitis, Active Ankylosing spondylitis, Active Psoriatic arthritis, Moderate Ulcerative colitis, Moderate, active Rheumatoid arthritis, Severe, active Rheumatoid arthritis

Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study

Phase 2
Recruiting
Conditions
Castration-Resistant Prostate Carcinoma
Prostate Adenocarcinoma
Interventions
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: PSMA PET Scan
Procedure: Bone Scan
First Posted Date
2023-07-27
Last Posted Date
2025-03-26
Lead Sponsor
University of Washington
Target Recruit Count
34
Registration Number
NCT05960578
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Biological: AVT05 (proposed biosimilar to golimumab)
First Posted Date
2023-05-03
Last Posted Date
2024-10-02
Lead Sponsor
Alvotech Swiss AG
Target Recruit Count
502
Registration Number
NCT05842213
Locations
🇧🇬

Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela, Plovdiv, Bulgaria

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Phase 3
Recruiting
Conditions
Psoriatic Arthritis
Interventions
First Posted Date
2023-01-03
Last Posted Date
2024-08-29
Lead Sponsor
University of Pennsylvania
Target Recruit Count
150
Registration Number
NCT05669833
Locations
🇺🇸

Family Arthritis Center, Loxahatchee Groves, Florida, United States

🇺🇸

Healing Rheumatology, Plant City, Florida, United States

🇺🇸

Southwest Florida Rheumatology, Riverview, Florida, United States

and more 11 locations

Effectiveness of Golimumab in Patients With Ulcerative Colitis: Results of a Real-life Study in Switzerland

Completed
Conditions
Ulcerative Colitis
Flare Up, Symptom
Interventions
First Posted Date
2022-06-06
Last Posted Date
2022-06-06
Lead Sponsor
University of Zurich
Target Recruit Count
103
Registration Number
NCT05405465
Locations
🇨🇭

Division of Gastroenterology, University Hospital Zurich, Zurich, Switzerland

A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi®

Phase 1
Completed
Conditions
Psoriatic Arthritis
Interventions
First Posted Date
2022-04-18
Last Posted Date
2023-08-28
Lead Sponsor
Bio-Thera Solutions
Target Recruit Count
375
Registration Number
NCT05332730
Locations
🇨🇳

The First Bethune Hospital of Jilin University, Changchun, Jilin, China

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 2
Active, not recruiting
Conditions
Colitis, Ulcerative
Interventions
First Posted Date
2022-02-16
Last Posted Date
2025-05-04
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
577
Registration Number
NCT05242484
Locations
🇩🇪

Praxisgemeinschaft Jerichow, Jerichow, Germany

🇩🇪

Eugastro GmbH, Leipzig, Germany

🇩🇪

Staedtisches Klinikum Lueneburg, Lueneburg, Germany

and more 386 locations

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

Phase 2
Active, not recruiting
Conditions
Crohn's Disease
Interventions
First Posted Date
2022-02-16
Last Posted Date
2025-04-27
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
703
Registration Number
NCT05242471
Locations
🇩🇪

Universitatsklinikum Schleswig Holstein Kiel, Kiel, Germany

🇩🇪

Evangelisches Krankenhaus Kalk, Köln, Germany

🇩🇪

Eugastro GmbH, Leipzig, Germany

and more 447 locations

A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Phase 2
Completed
Conditions
Arthritis, Psoriatic
Interventions
First Posted Date
2021-10-08
Last Posted Date
2025-05-14
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
91
Registration Number
NCT05071664
Locations
🇵🇱

WroMedica I Bielicka A Strzalkowska s c, Wroclaw, Poland

🇺🇸

Arizona Arthritis and Rheumatology Research PLLC, Phoenix, Arizona, United States

🇺🇸

Unity Health-White County Medical Center, Searcy, Arkansas, United States

and more 78 locations

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis

Phase 3
Completed
Conditions
Psoriatic Arthritis
Interventions
First Posted Date
2021-09-16
Last Posted Date
2023-10-12
Lead Sponsor
Bio-Thera Solutions
Target Recruit Count
704
Registration Number
NCT05046431
Locations
🇨🇳

West China Hospital Sichuan University, Chengdu, China

Anti-TNFα to Delay or Prevent Progression to Stage 3 T1D

Phase 2
Withdrawn
Conditions
Diabetes Mellitus, Type 1
Interventions
Drug: Placebo
First Posted Date
2021-01-28
Last Posted Date
2021-12-02
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Registration Number
NCT04729296
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