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 in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

Phase 3
Completed
Conditions
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Interventions
First Posted Date
2009-10-30
Last Posted Date
2015-04-30
Lead Sponsor
Janssen Biotech, Inc.
Target Recruit Count
433
Registration Number
NCT01004432

An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy

Phase 3
Completed
Conditions
Arthritis, Rheumatoid
Interventions
First Posted Date
2009-09-09
Last Posted Date
2013-12-25
Lead Sponsor
Centocor, Inc.
Target Recruit Count
592
Registration Number
NCT00973479

A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis

Phase 2
Completed
Conditions
Sarcoidosis
Interventions
First Posted Date
2009-08-10
Last Posted Date
2014-07-17
Lead Sponsor
Centocor, Inc.
Target Recruit Count
173
Registration Number
NCT00955279

A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Placebo
First Posted Date
2008-10-13
Last Posted Date
2015-11-03
Lead Sponsor
Janssen Pharmaceutical K.K.
Target Recruit Count
311
Registration Number
NCT00771251

A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2008-08-05
Last Posted Date
2013-05-23
Lead Sponsor
Janssen Pharmaceutical K.K.
Target Recruit Count
269
Registration Number
NCT00727987

An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

Phase 2
Terminated
Conditions
Colitis, Ulcerative
Interventions
First Posted Date
2007-06-20
Last Posted Date
2013-06-14
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
291
Registration Number
NCT00488774

A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2006-08-08
Last Posted Date
2014-07-29
Lead Sponsor
Centocor, Inc.
Target Recruit Count
643
Registration Number
NCT00361335

An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Placebo capsules
Drug: Placebo injection
First Posted Date
2005-12-13
Last Posted Date
2014-04-29
Lead Sponsor
Centocor, Inc.
Target Recruit Count
444
Registration Number
NCT00264550

A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma

Phase 2
Completed
Conditions
Asthma
Interventions
Drug: Placebo
First Posted Date
2005-09-21
Last Posted Date
2012-08-20
Lead Sponsor
Centocor, Inc.
Target Recruit Count
309
Registration Number
NCT00207740

An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2005-09-21
Last Posted Date
2012-10-18
Lead Sponsor
Centocor, Inc.
Target Recruit Count
172
Registration Number
NCT00207714
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