Drugs / Certolizumab Pegol
last change Jul 2026 re-read 2 minutes ago

Certolizumab Pegol

Protein / enzyme biologic targets TNF via inhibition

Developed for
rheumatoid arthritis · Crohn disease · psoriasis · psoriatic arthritis · spondyloarthropathy · ankylosing spondylitis · pregnancy disorder · anterior uveitis
+7 more · antiphospholipid syndrome · polyarticular juvenile idiopathic arthritis · spermatogenic failure · Takayasu arteritis · ulcerative colitis · interstitial cystitis · type 2 diabetes mellitus
Investigated by
UCB Pharma · UCB BIOSCIENCES, Inc. · UCB Biopharma SRL · Parexel · UCB Japan Co. Ltd. · UCB Biopharma S.P.R.L.
+34 more · Astellas Pharma Inc · PPD Development, LP · Korea Otsuka Pharmaceutical Co., Ltd. · Otsuka Pharmaceutical Co., Ltd. · Shafran Gastroenterology Center · Chang Gung Memorial Hospital · China Medical University Hospital · Chung Shan Medical University · Columbia University · David Ware Branch · Far Eastern Memorial Hospital · Hospital for Special Surgery, New York · Julia Brown · Marmara University · Milton S. Hershey Medical Center · NYU Langone Health · Nathan Wei, MD, FACP, FACR · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Oklahoma Medical Research Foundation · PRA Health Sciences · RenJi Hospital · Rüdiger B. Müller · Taichung Veterans General Hospital · UCB Italy s.p.a. · UCB Pharma · University Health Network, Toronto · University Hospital, Ghent · University of California, San Diego · University of Erlangen-Nürnberg Medical School · University of Illinois at Chicago · University of Pennsylvania · University of Toronto · University of Washington · Vastra Gotaland Region

Regulatory milestones approvals, filings & regulatory actions · 11 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (8) US (FDA) CIMZIA 2009-05-13 – 2024-09-13 fda.gov
Approved EU (EMA) Cimzia 2009-10-01 europa.eu
Refused (EMA) EU (EMA) Cimzia 2008-05-21 europa.eu
Approved US (FDA) CIMZIA 2008-04-22 fda.gov

Trials 89 · started per year

today
US approved 2008
EU approved 2009
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2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT04740814 Feb 2021 → Jan 2022 rheumatoid arthritis UCB Biopharma SRL Completed No outcome recorded
Phase 1 NCT04163016 Jun 2020 → May 2023 Crohn disease, psoriasis, psoriatic arthritis, spondyloarthropathy UCB Biopharma SRL Completed No outcome recorded
Phase 1 NCT02365948 Mar → Aug 2015 UCB Pharma Completed No outcome recorded
Phase 1 NCT02154425 Sep 2014 → Dec 2015 Crohn disease, ankylosing spondylitis, psoriatic arthritis UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 1 NCT02019602 Jan 2014 → Oct 2016 Crohn disease, ankylosing spondylitis, psoriatic arthritis UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 1 NCT01091220 Mar 2010 → Mar 2011 spermatogenic failure UCB Pharma Completed No outcome recorded
Phase 1 NCT00813774 Feb → Jul 2008 UCB Pharma Completed No outcome recorded
Phase 210 trials
Phase 2 NCT03215277 Oct 2017 → May 2020 ankylosing spondylitis UCB Biopharma SRL Completed No outcome recorded
Phase 2 NCT03152058 May 2017 → Dec 2027 expected antiphospholipid syndrome, pregnancy disorder David Ware Branch Recruiting No outcome recorded
Phase 2 NCT02293590 Nov 2013 → Dec 2017 rheumatoid arthritis Rüdiger B. Müller Completed No outcome recorded
Phase 2 NCT01090154 Dec 2010 → Dec 2021 ulcerative colitis University of Washington Completed No outcome recorded
Phase 2 NCT01190410 Aug 2010 → Nov 2017 Crohn disease UCB Pharma Completed No outcome recorded
Phase 2 NCT00329550 May 2006 → Apr 2008 Crohn disease UCB Japan Co. Ltd. Completed No outcome recorded
Phase 2 NCT00329420 May 2006 → May 2008 Crohn disease UCB Pharma Completed No outcome recorded
Phase 2 NCT00329303 Apr 2006 → May 2007 psoriasis UCB Pharma Completed No outcome recorded
Phase 2 NCT00291668 Mar 2006 → Nov 2007 Crohn disease UCB Pharma Completed No outcome recorded
Phase 2 NCT00245765 Oct 2005 → Nov 2006 psoriasis UCB Pharma Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT03051217 Feb 2017 → Nov 2018 psoriasis UCB Biopharma S.P.R.L. Completed No outcome recorded
Phase 2/3 NCT00791999 Nov 2008 → Jan 2010 rheumatoid arthritis Otsuka Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 352 trials
Phase 3 NCT04643483 Jun 2021 → Sep 2023 Crohn disease UCB Biopharma SRL Withdrawn No outcome recorded
Phase 3 NCT04610476 Oct 2020 → Oct 2024 psoriatic arthritis, substance withdrawal syndrome University of Erlangen-Nürnberg Medical School Unknown No outcome recorded
Phase 3 NCT04123795 Jan 2020 → Apr 2026 overdue psoriasis UCB Biopharma SRL Active not recruiting No outcome recorded
Phase 3 NCT03357471 Nov 2017 → Jul 2018 ankylosing spondylitis, inflammatory bowel disease, psoriatic arthritis UCB Biopharma S.P.R.L. Completed No outcome recorded
Phase 3 NCT02552212 Sep 2015 → May 2018 spondyloarthropathy UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 3 NCT02505542 Jul 2015 → Feb 2019 ankylosing spondylitis UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 3 NCT02346240 Feb 2015 → Mar 2016 psoriasis UCB Biopharma S.P.R.L. Completed No outcome recorded
Phase 3 NCT02326298 Dec 2014 → Mar 2016 psoriasis UCB Biopharma S.P.R.L. Completed No outcome recorded
Phase 3 NCT02326272 Dec 2014 → Jan 2016 psoriasis UCB Biopharma S.P.R.L. Completed No outcome recorded
Phase 3 NCT02319642 Nov 2014 → Dec 2016 rheumatoid arthritis UCB Pharma Completed No outcome recorded
Phase 412 trials
Phase 4 NCT07149792 Jul 2025 → Dec 2026 expected psoriasis, psoriatic arthritis Taichung Veterans General Hospital Recruiting No outcome recorded
Phase 4 NCT05115903 Dec 2021 → Jul 2024 spondyloarthropathy University Health Network, Toronto Unknown No outcome recorded
Phase 4 NCT03020992 Dec 2016 → Dec 2019 anterior uveitis, spondyloarthropathy UCB Biopharma SRL Completed No outcome recorded
Phase 4 NCT02597829 Nov 2015 → May 2018 Crohn disease Shafran Gastroenterology Center Unknown No outcome recorded
Phase 4 NCT02451748 Aug 2015 → Sep 2017 rheumatoid arthritis University of Illinois at Chicago Completed No outcome recorded
Phase 4 NCT01696942 Feb 2013 → Jun 2016 Crohn disease Milton S. Hershey Medical Center Terminated No outcome recorded
Phase 4 NCT01443364 Dec 2011 → May 2015 rheumatoid arthritis UCB Italy s.p.a. Completed No outcome recorded
Phase 4 NCT01548768 Oct 2011 → Sep 2019 rheumatoid arthritis Columbia University Completed No outcome recorded
Phase 4 NCT01295151 Aug 2011 → Nov 2015 rheumatoid arthritis Julia Brown Completed No outcome recorded
Phase 4 NCT01255761 Nov 2010 → Oct 2012 rheumatoid arthritis UCB Pharma Completed No outcome recorded
Phase not applicable4 trials
NCT07491913 Jun 2025 → Dec 2027 expected Takayasu arteritis Marmara University Recruiting No outcome recorded
NCT04569890 Dec 2020 → Dec 2022 pregnancy disorder, rheumatoid arthritis RenJi Hospital Unknown No outcome recorded
NCT04378621 Oct 2020 → Sep 2025 depressive disorder, rheumatoid arthritis, subjective cognitive decline Vastra Gotaland Region Unknown No outcome recorded
NCT01053559 Jan 2010 → Sep 2013 Crohn disease Shafran Gastroenterology Center Completed No outcome recorded
Phase not stated2 trials
NCT03559686 rheumatoid arthritis UCB Biopharma SRL No longer available No outcome recorded
NCT03559660 Crohn disease UCB Biopharma SRL No longer available No outcome recorded
Also used as a comparator or background therapy in 13 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT02430909 Background Apr 2015 → Apr 2017 rheumatoid arthritis UCB Celltech Completed No outcome recorded
Phase 2 NCT00899678 Comparator Apr 2009 → Jul 2012 Crohn disease UCB Celltech Terminated No outcome recorded
Phase 33 trials
Phase 3 NCT02497976 Comparator Dec 2015 → Apr 2017 interstitial cystitis ICStudy, LLC Completed No outcome recorded
Phase 3 NCT01864265 Comparator Jul 2013 → Jun 2019 rheumatoid arthritis University of Erlangen-Nürnberg Medical School Completed No outcome recorded
Phase 3 NCT01817972 Comparator Mar 2013 → Jun 2014 Crohn disease Gastroenterology Research of America Unknown No outcome recorded
Phase 48 trials
Phase 4 NCT03100253 Comparator Mar 2018 → Dec 2021 rheumatoid arthritis Mario Negri Institute for Pharmacological Research Terminated No outcome recorded
Phase 4 NCT02353780 Comparator Mar 2015 → Dec 2017 rheumatoid arthritis Dr. Larry W. Moreland Terminated No outcome recorded
Phase 4 NCT02466581 Comparator Feb 2015 → Jul 2023 rheumatoid arthritis Karolinska Institutet Unknown No outcome recorded
Phase 4 NCT02236481 Comparator Jul 2013 → Dec 2017 rheumatoid arthritis, type 2 diabetes mellitus Prof. Roberto Giacomelli Terminated No outcome recorded
Phase 4 NCT01491815 Comparator Dec 2012 → Jul 2023 rheumatoid arthritis Karolinska Institutet Unknown No outcome recorded

Press releases naming this drug 2 releases

DateIssuerRelease
2011-11-08 Otsuka Pharmaceutical Development & Commercialization, Inc. Results of two trials show a rapid and sustained response with certolizumab pegol for treatment of rheumatoid arthritis (J-RAPID and HIKARI Studies) released at 2011 meeting of American College of Rheumatology (ACR) otsuka.co.jp
2008-06-10 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka and UCB agreed to co-develop and co-promote Keppra and Cimzia in Japan®® otsuka.co.jp

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 113 sources stand behind the page.

FieldValueCited text
Known as certolizumab pegol “This 24-week, placebo-controlled, double-blind, randomized study (NCT00791921) investigated efficacy and safety of certolizumab pegol (CZP) in Japanese rheumatoid arthritis...” PMID 24981319 Nov 2013
92

“To be given subcutaneously via a prefilled syringe/autoinjector (etanercept, adalimumab, certolizumab pegol, golimumab) or intravenously via infusion (infliximab) at increasing...” NCT05115903

“TNF-a inhibitors: Etanercept (Enbrel, Benapali), Infliximab (Remicade, Inflectra, Flixabi), Adalimumab (Humira, Imraldi, AMGEVITA), Certolizumabpegol (Cimzia), Golimumab (Simponi)” NCT04378621

“The anti-TNFα used in this trial is certolizumab pegol (Cimzia®), a pegylated Fab'-fragment of a monoclonal antibody with high specificity for TNFα.” NCT01590966

“Participants were randomised to anakinra or to a TNFi (i.e., adalimumab, certolizumab pegol, etanercept, infliximab, or golimumab)” PMID 31513665 Sep 2019

Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis” NCT00993317

“200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).” NCT01087788

“200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).” NCT01087762

“induction of Certolizumab Pegol administered subcutaneously every 2 weeks” NCT00899678

“Cimzia: Certolizumab-pegol plus Methotrexate and steroids” NCT01491815

“Certolizumab-pegol: 200 mg s.c. every other week.” NCT01491815

“* Active Substance: Certolizumab PegolNCT03357471

Certolizumab pegol (Cimzia)” NCT07149792

Certolizumab pegolNCT02451748

NCT01235598

NCT01255761

NCT03100253

NCT00354367

NCT01213017

NCT01521923

NCT04123795

NCT01864265

NCT01443364

NCT00308581

NCT00329550

NCT01550003

NCT00356408

NCT00307931

NCT04643483

NCT00813774

NCT00358683

NCT00333788

NCT01519791

NCT00297648

NCT00753454

NCT03152058

NCT00175877

NCT02505542

NCT00291668

NCT01190410

NCT02151851

NCT02154425

NCT02597829

NCT01295151

NCT00851318

NCT04740814

NCT01091220

NCT02293590

NCT03559686

NCT00850343

NCT02497976

NCT02365948

NCT03559660

NCT01500278

NCT04163016

NCT02346240

NCT00152425

NCT00843778

NCT02430909

NCT01053559

NCT00552058

NCT00993668

NCT04569890

NCT01374971

NCT02326298

NCT07491913

NCT01024647

NCT01197066

NCT02019602

NCT04610476

NCT03215277

NCT02326272

NCT03051217

NCT00152490

NCT01292265

NCT00580840

NCT00152386

NCT00674362

NCT00349752

NCT03020992

NCT00160524

NCT02319642

NCT00329420

NCT00160602

NCT00717236

NCT00245765

NCT00160693

NCT01817972

NCT00329303

NCT02451748

NCT02552212

NCT00160706

NCT00160641

Known as CDP870 “The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms...” NCT00993317
10

“Multicentre, Double-blind Study to Describe the Efficacy and Safety of Re-treatment With CDP870 (Certolizumab Pegol) Subcutaneous” NCT00329303

“Certolizumab pegol (CDP870, tradename Cimzia) or is provided in prefilled syringes at the dose of 200mg.” NCT02451748

“Certolizumab Pegol (CDP870)” NCT00152490

“Certolizumab Pegol (CDP870)” NCT00152425

“Certolizumab pegol (CDP870)” NCT00152386

NCT02586246

NCT00791999

NCT00544154

NCT00791921

NCT00548834

Known as Certolizumab “The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms...” NCT00993317
Known as Cimzia “The anti-TNFα used in this trial is certolizumab pegol (Cimzia®), a pegylated Fab'-fragment of a monoclonal antibody with high specificity for TNFα.” NCT01590966
14

“Certolizumab pegol (CDP870, tradename Cimzia) or is provided in prefilled syringes at the dose of 200mg.” NCT02451748

“A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)” NCT04163016

“The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.” NCT01548768

Cimzia: Certolizumab-pegol plus Methotrexate and steroids” NCT01491815

“Certolizumab Pegol 200 MG/ML [Cimzia]” NCT04569890

“Certolizumab Pegol (CIMZIA®, CZP)” NCT03559660

“Certolizumab Pegol (Cimzia®)” NCT00329303

“Certolizumab pegol (Cimzia)” NCT07149792

NCT01696942

NCT02353780

NCT01090154

NCT00552344

NCT01147341

NCT02466581

Known as Cimzia (R) “Certolizumab pegol (Cimzia (R), CZP) CZP of 400mg at Weeks 0, 2 and 4, followed by 200mg injections from Week 6, every 2 weeks until Week 24.” NCT02293590
Known as CZP “This 52-week, randomised, double-blind phase IIIb study assessed efficacy and safety of certolizumab pegol (CZP) as add-on therapy to non-biologic disease-modifying...” PMID 24431394 Jan 2014
21

“The objective of this Named Patient Program (NPP) is to provide continued availability of Certolizumab Pegol (CZP) to adult Rheumatoid Arthritis (RA) patients who participated...” NCT03559686

“The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms...” NCT00993317

“This 24-week, placebo-controlled, double-blind, randomized study (NCT00791921) investigated efficacy and safety of certolizumab pegol (CZP) in Japanese rheumatoid arthritis...” PMID 24981319 Nov 2013

“The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study...” NCT04163016

“Mothers who decided to continue on, or to start treatment with, Certolizumab Pegol (CZP) for an approved indication with their treating physician prior to participation into this study.” NCT02154425

“This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.” NCT00717236

“The objective of this study was to examine the safety and benefits of certolizumab pegol (CZP)+methotrexate (MTX) treatment for almost 5 years in patients with RA.” PMID 26353833 Sep 2015

“This study evaluated placental transfer of certolizumab pegol (CZP), an Fc-free anti-tumour necrosis factor drug, from CZP-treated pregnant women to their infants.” PMID 29030361 Oct 2017

“400 mg of Cimzia (CZP) given as two 200 mg subcutaneous (sc) injections at weeks 0, 2, and 4, followed by 1 sc injection at weeks 6, 8, and 10.” NCT01147341

“Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.” NCT00175877

“Certolizumab pegol (Cimzia (R), CZP) CZP of 400mg at Weeks 0, 2 and 4, followed by 200mg injections from Week 6, every 2 weeks until Week 24.” NCT02293590

“Certolizumab pegol (CZP) is an effective therapy for Crohn's disease refractory to aminosalicylates, corticosteroids and immunosuppressants.” PMID 20491747 May 2010

“Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF agent approved for the treatment of rheumatic diseases and/or Crohn's disease” PMID 29623679 Jul 2018

“Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.” NCT00160641

CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate.” NCT01374971

“200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).” NCT01087788

“in addition to certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA)” PMID 31177099 Jun 2019

“Certolizumab pegol (CZP) is a PEGylated antitumour necrosis factor agent.” PMID 22413944 Jun 2012

“Certolizumab Pegol (CIMZIA®, CZP)” NCT03559660

“Certolizumab Pegol (CZP)” NCT01550003

“Certolizumab Pegol (CZP)” NCT01255761

Known as UCB product: Certolizumab Pegol (CDP870) UCB product: Certolizumab Pegol (CDP870)NCT01374971
Action Inhibit “a novel PEGylated anti-tumor necrosis factor agent” PMID 18975346 Nov 2008
Modality Protein / enzyme biologic “pegylated humanized Fab' fragment” PMID 17634459 Jul 2007
Route Subcutaneous “treatment with subcutaneous certolizumab pegol at an initial dosage of 400 mg given at weeks 0, 2, and 4, with a subsequent dosage of 200 mg or 400 mg given every 2 weeks” PMID 18975346 Nov 2008
Target TNF “Certolizumab pegol is a pegylated humanized Fab' fragment that binds tumor necrosis factor alpha.” PMID 17634458 Jul 2007