Golimumab

Generic Name
Golimumab
Brand Names
Simponi
Drug Type
Biotech
Chemical Formula
-
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 se...

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 w...

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
Associated Therapies
-
Clinical Trials
Related News

Initial Treatment With Golimumab in Early PsA

Phase 3
Completed
Conditions
Psoriatic Arthritis
Interventions
Drug: methotrexate
Drug: golimumab
First Posted Date
2013-06-07
Last Posted Date
2018-11-26
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
51
Registration Number
NCT01871649
Locations
🇳🇱

Reade, Amsterdam, Noord Holland, Netherlands

🇳🇱

Academic Medical Center/University of Amsterdam, Amsterdam, Noord Holland, Netherlands

A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.

Phase 3
Completed
Conditions
Colitis, Ulcerative
Interventions
Other: Placebo
Drug: Golimumab
First Posted Date
2013-05-29
Last Posted Date
2017-04-05
Lead Sponsor
Janssen Pharmaceutical K.K.
Target Recruit Count
144
Registration Number
NCT01863771

A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)

First Posted Date
2013-03-05
Last Posted Date
2021-03-04
Lead Sponsor
Janssen Scientific Affairs, LLC
Target Recruit Count
1
Registration Number
NCT01804166

Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial

Phase 4
Completed
Conditions
Spondyloarthropathy
Interventions
Drug: Pamidronate
Drug: golimumab
First Posted Date
2012-11-01
Last Posted Date
2015-05-12
Lead Sponsor
Tuen Mun Hospital
Target Recruit Count
30
Registration Number
NCT01718951
Locations
🇭🇰

Tuen Mun Hospital, Hong Kong, Hong Kong

Intratympanic Injection for Autoimmune Inner Ear Disease

Phase 1
Terminated
Conditions
Autoimmune Inner Ear Disease
Interventions
Drug: Golimumab
First Posted Date
2012-02-03
Last Posted Date
2013-10-14
Lead Sponsor
House Research Institute
Target Recruit Count
16
Registration Number
NCT01526174

Exploration of TNF-alpha Blockade With Golimumab in the Induction of Clinical Remission in Patients With Early Peripheral Spondyloarthritis (SpA) According to ASAS-criteria

Phase 3
Completed
Conditions
Peripheral Spondylarthritis
Interventions
Drug: Placebo
Drug: Golimumab
First Posted Date
2011-08-31
Last Posted Date
2019-05-29
Lead Sponsor
University Hospital, Ghent
Target Recruit Count
60
Registration Number
NCT01426815
Locations
🇧🇪

Ghent University Hospital, Ghent, Belgium

A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Golimumab
First Posted Date
2011-05-30
Last Posted Date
2017-10-02
Lead Sponsor
Centocor, Inc.
Target Recruit Count
49
Registration Number
NCT01362153

SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.

First Posted Date
2011-02-14
Last Posted Date
2016-11-02
Lead Sponsor
Julia Brown
Target Recruit Count
122
Registration Number
NCT01295151
Locations
🇬🇧

Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, West Yorkshire, United Kingdom

A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

Phase 1
Completed
Conditions
Healthy Adult Chinese Males
Interventions
Drug: Golimumab
First Posted Date
2011-02-02
Last Posted Date
2014-05-28
Lead Sponsor
Centocor, Inc.
Target Recruit Count
24
Registration Number
NCT01288157

Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis

First Posted Date
2010-11-25
Last Posted Date
2013-03-20
Lead Sponsor
Centocor, Inc.
Target Recruit Count
213
Registration Number
NCT01248793
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