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 and Methotrexate Versus Methotrexate in Very Early PsA (GOLMEPsA)
- First Posted Date
- 2019-09-30
- Last Posted Date
- 2024-01-10
- Lead Sponsor
- The Leeds Teaching Hospitals NHS Trust
- Target Recruit Count
- 84
- Registration Number
- NCT04108468
- Locations
- 🇬🇧
The Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, United Kingdom
Pre-Approval Access to Golimumab Subcutaneous for the Treatment of Stage 3 Type-1 Diabetes Mellitus in Children and Young Adults
- Conditions
- First Posted Date
- 2019-05-10
- Last Posted Date
- 2023-04-13
- Lead Sponsor
- Janssen Research & Development, LLC
- Registration Number
- NCT03945903
- Locations
- 🇺🇸
Rady Children's Hospital, San Diego, California, United States
A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
- First Posted Date
- 2018-11-07
- Last Posted Date
- 2023-01-20
- Lead Sponsor
- Johnson & Johnson Private Limited
- Target Recruit Count
- 100
- Registration Number
- NCT03733925
- Locations
- 🇮🇳
ChanRe Rheumatology & Immunology Center & Research, Bangalore, India
🇮🇳Apollo Hospitals, Bhubaneswar, India
🇮🇳Indraprastha Apollo Hospital, New Delhi, India
Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D
- Conditions
- Interventions
- First Posted Date
- 2018-08-15
- Last Posted Date
- 2022-01-24
- Lead Sponsor
- Carla Greenbaum, MD
- Target Recruit Count
- 16
- Registration Number
- NCT03632759
- Locations
- 🇺🇸
Benaroya Research Institute, Seattle, Washington, United States
🇺🇸Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, United States
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Interventions
- First Posted Date
- 2018-07-24
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 84
- Registration Number
- NCT03596645
- Locations
- 🇺🇸
Children's Hospital Colorado and University of Colorado, Aurora, Colorado, United States
🇪🇸Hosp Regional Univ de Malaga, Málaga, Spain
🇺🇸University of California San Francisco, San Francisco, California, United States
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
- Conditions
- Interventions
- First Posted Date
- 2018-01-30
- Last Posted Date
- 2024-06-24
- Lead Sponsor
- University of Nebraska
- Target Recruit Count
- 400
- Registration Number
- NCT03414502
- Locations
- 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes
- First Posted Date
- 2017-10-02
- Last Posted Date
- 2021-09-16
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 8
- Registration Number
- NCT03298542
- Locations
- 🇺🇸
UC Denver-Colorado Barbara Davis Center, University of Colorado SOM Pediatric Endocrinology, Aurora, Colorado, United States
🇺🇸Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇸🇪Lund University Hospital/Skåne, Lund/Malmo, Sweden
Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation
- First Posted Date
- 2017-09-01
- Last Posted Date
- 2024-01-09
- Lead Sponsor
- University Ghent
- Target Recruit Count
- 64
- Registration Number
- NCT03270501
- Locations
- 🇧🇪
Ghent University Hospital, Ghent, B - Belgium, Belgium
🇧🇪Reuma Instituut Hasselt, Hasselt, Limburg, Belgium
🇧🇪Imelda Bonheiden, Bonheiden, Antwerpen, Belgium
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
- First Posted Date
- 2017-04-21
- Last Posted Date
- 2021-07-06
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Target Recruit Count
- 112
- Registration Number
- NCT03124121
- Locations
- 🇬🇧
Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom
Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation
- Conditions
- Interventions
- First Posted Date
- 2017-04-04
- Last Posted Date
- 2022-09-19
- Target Recruit Count
- 208
- Registration Number
- NCT03100253
- Locations
- 🇮🇹
Policlinico Sant'Orsola Malpighi, Bologna, Italy
🇮🇹Azienda Consorziale Ospedaliera Policlinico, Bari, Italy
🇮🇹Azienda Socio Sanitaria Territoriale - Papa Giovanni XXIII, Bergamo, Italy
Drug Development Updates
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