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
- -
Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis
- First Posted Date
- 2017-01-12
- Last Posted Date
- 2021-07-19
- Target Recruit Count
- 15
- Registration Number
- NCT03018925
- Locations
- 🇪🇸
Hospital Doctor Josep Trueta, Girona, Catalonia, Spain
Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET
- First Posted Date
- 2015-04-24
- Last Posted Date
- 2023-05-31
- Target Recruit Count
- 202
- Registration Number
- NCT02425865
- Locations
- 🇧🇪
CHU Dinant Godinne UCL Namur, NAmur, Belgium
🇫🇷CHU de Saint Etienne- Hopital Nord, Saint-Priest-en-Jarez, France
🇫🇷Chu Strasbourg, Strasbourg, France
Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission
- First Posted Date
- 2015-04-08
- Last Posted Date
- 2015-04-08
- Lead Sponsor
- Istituto Clinico Humanitas
- Target Recruit Count
- 100
- Registration Number
- NCT02412085
- Locations
- 🇮🇹
IBD Center, Rozzano, MI, Italy
A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
- First Posted Date
- 2014-10-29
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 130
- Registration Number
- NCT02277444
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
- First Posted Date
- 2014-07-10
- Last Posted Date
- 2017-12-22
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 208
- Registration Number
- NCT02186873
Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab
- First Posted Date
- 2014-07-10
- Last Posted Date
- 2014-07-10
- Lead Sponsor
- Kliniken im Naturpark Altmuehltal
- Target Recruit Count
- 50
- Registration Number
- NCT02186886
- Locations
- 🇩🇪
Kliniken im Naturpark Altmuehltal; Klinik Koesching, Kosching, Germany
A Study of Golimumab in Participants With Active Psoriatic Arthritis
- First Posted Date
- 2014-07-04
- Last Posted Date
- 2017-12-21
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 480
- Registration Number
- NCT02181673
Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)
- First Posted Date
- 2014-03-20
- Last Posted Date
- 2019-03-15
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 205
- Registration Number
- NCT02092285
- Locations
- 🇬🇧
Merck Sharp & Dohme Ltd., Hoddesdon, United Kingdom
Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients
- Conditions
- Interventions
- First Posted Date
- 2014-02-19
- Last Posted Date
- 2020-11-13
- Target Recruit Count
- 44
- Registration Number
- NCT02065713
- Locations
- 🇵🇹
Centro Académico de Medicina de Lisboa, Lisbon, Portugal
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
- First Posted Date
- 2013-07-16
- Last Posted Date
- 2023-05-11
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 35
- Registration Number
- NCT01900574
Drug Development Updates
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