Certolizumab pegol

Generic Name
Certolizumab pegol
Brand Names
Cimzia
Drug Type
Biotech
Chemical Formula
-
CAS Number
428863-50-7
Unique Ingredient Identifier
UMD07X179E
Background

Certolizumab pegol is a pegylated monoclonal antibody against the tumor necrosis factor-alpha (TNF-alpha). It is formed with a humanized Fab fragment of 50 kDa, from an IgG 1 isotype, fused to a 40 kDa polyethylene glycol moiety replacing the Fc antibody region. The absence of the Fc region was ideated to prevent complement fixation and antibody-mediated cyt...

Indication

Certolizumab pegol has been approved for several different conditions listed below:
...

Associated Conditions
Moderate to Severe Plaque Psoriasis, Moderately to Severely Active Rheumatoid Arthritis, Non-radiographic Axial Spondyloarthritis, Psoriatic Arthritis, Severe Crohn's Disease, Active Ankylosing spondylitis, Active Psoriatic arthritis, Moderate Crohn’s Disease, Moderate Psoriatic Arthritis, Moderate Rheumatoid arthritis, Severe Psoriatic Arthritis, Severe Rheumatoid arthritis
Associated Therapies
-

A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

First Posted Date
2017-02-13
Last Posted Date
2022-01-04
Lead Sponsor
UCB Biopharma S.P.R.L.
Target Recruit Count
127
Registration Number
NCT03051217
Locations
🇯🇵

Ps0017 009, Minatoku, Japan

🇯🇵

Ps0017 041, Matsumoto, Japan

🇯🇵

Ps0017 027, Sendai, Japan

and more 30 locations

A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU

First Posted Date
2017-01-13
Last Posted Date
2021-02-09
Lead Sponsor
UCB Biopharma SRL
Target Recruit Count
89
Registration Number
NCT03020992
Locations
🇵🇱

As0007 509, Poznań, Poland

🇨🇿

As0007 103, Brno, Czechia

🇩🇪

As0007 302, München, Germany

and more 20 locations

Does Clinical Response Correlate With Serum Certolizumab Levels?

Phase 4
Conditions
Interventions
First Posted Date
2015-11-05
Last Posted Date
2015-11-05
Lead Sponsor
Shafran Gastroenterology Center
Target Recruit Count
20
Registration Number
NCT02597829
Locations
🇺🇸

Shafran Gastroenterology Center, Winter Park, Florida, United States

An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-12-18
Last Posted Date
2018-10-16
Lead Sponsor
UCB Pharma SA
Target Recruit Count
347
Registration Number
NCT02319642
Locations
🇨🇳

013, Beijing, China

🇨🇳

025, Beijing, China

🇨🇳

021, Beijing, China

and more 27 locations

RICE: Remission by Intra-articular Injection Plus CErtolizumab

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-11-18
Last Posted Date
2018-08-03
Lead Sponsor
Rüdiger B. Müller
Target Recruit Count
43
Registration Number
NCT02293590
Locations
🇨🇭

Kantonsspital St. Gallen, St. Gallen, Saint Gallen, Switzerland

Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-05-29
Last Posted Date
2020-03-10
Lead Sponsor
University of Erlangen-Nürnberg Medical School
Target Recruit Count
156
Registration Number
NCT01864265
Locations
🇩🇪

University of Erlangen-Nuremberg, Department of Internal Medicine 3, Rheumatology & Immunology, Erlangen, Germany

🇩🇪

Medizinische Universitätsklinik Freiburg Abteilung Rheumatologie und Klinische Immunologie, Freiburg, Germany

🇩🇪

Universitätsklinikum Leipzig AÖR Department Innere Medizin Sektion Rheumatologie, Leipzig, Germany

and more 3 locations

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

The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-10-01
Last Posted Date
2017-12-07
Lead Sponsor
Oklahoma Medical Research Foundation
Target Recruit Count
20
Registration Number
NCT01213017
Locations
🇺🇸

Arthritis and Rheumatic Disease Specialties, Aventura, Florida, United States

🇺🇸

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States

Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-09-09
Last Posted Date
2022-06-10
Lead Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
110
Registration Number
NCT01197066

Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-08-27
Last Posted Date
2020-12-17
Lead Sponsor
UCB Pharma
Target Recruit Count
16
Registration Number
NCT01190410
Locations
🇺🇸

126, Morristown, New Jersey, United States

🇺🇸

104, Baltimore, Maryland, United States

🇺🇸

114, Orange, California, United States

and more 7 locations
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