Drugs / Certolizumab Pegol
Certolizumab Pegol
also known as
CZP · CDP870 · Cimzia · Certolizumab · Cimzia (R) · UCB product: Certolizumab Pegol (CDP870)
Protein / enzyme biologic targets TNF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Crohn jejunoileitis 2 milestones | |||||
| Filed | EU (EMA) | Cimzia | Crohn jejunoileitis | — | “UCB filed for regulatory approval earlier this year for Cimzia(TM) in both the U.S. (February 2006) and the EU (April 2006)” nektar.com ↗ |
| Filed | US (FDA) | Cimzia | Crohn jejunoileitis | — | “UCB filed for regulatory approval earlier this year for Cimzia(TM) in both the U.S. (February 2006) and the EU (April 2006)” nektar.com ↗ |
| Filed rheumatoid arthritis 1 milestone | |||||
| Filed | Japan (PMDA) | — | rheumatoid arthritis | — | “UCB filed certolizumab pegol for marketing authorisation with the Japanese Ministry of Health, Labour and Welfare for the indication of rheumatoid arthritis” astellas.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (7) | 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 85 · started per year
today
US approved 2008
EU approved 2009
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 29 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT03215277 | Oct 2017 → May 2020 | ankylosing spondylitis | UCB Biopharma SRL | Completed | Missed primary |
| 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 | 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 | Met primary |
| 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 | Met primary |
| Phase 2/32 trials · 2 met primary | ||||||
| Phase 2/3 | NCT03051217 | Feb 2017 → Nov 2018 | psoriasis | UCB Biopharma S.P.R.L. | Completed | Met primary |
| Phase 2/3 | NCT00791999 | Nov 2008 → Jan 2010 | rheumatoid arthritis | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 351 trials · 17 met primary · 2 missed | ||||||
| Phase 3 | NCT04643483 | Jun 2021 → Sep 2023 | Crohn disease | UCB Biopharma SRL | Withdrawn | No outcome recorded Stop: Business |
| 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 | Met primary |
| Phase 3 | NCT02505542 | Jul 2015 → Feb 2019 | ankylosing spondylitis | UCB BIOSCIENCES, Inc. | Completed | Met primary |
| Phase 3 | NCT02346240 | Feb 2015 → Mar 2016 | psoriasis | UCB Biopharma S.P.R.L. | Completed | Met primary |
| Phase 3 | NCT02326298 | Dec 2014 → Mar 2016 | psoriasis | UCB Biopharma S.P.R.L. | Completed | Met primary |
| Phase 3 | NCT02326272 | Dec 2014 → Jan 2016 | psoriasis | UCB Biopharma S.P.R.L. | Completed | Met primary |
| Phase 3 | NCT02319642 | Nov 2014 → Dec 2016 | rheumatoid arthritis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT02151851 | Jul 2014 → Jun 2016 | rheumatoid arthritis | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT01590966 | Oct 2012 → Mar 2019 | rheumatoid arthritis, spondyloarthropathy | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 3 | NCT01550003 | Mar 2012 → Apr 2024 | polyarticular juvenile idiopathic arthritis | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01521923 | Jan 2012 → Jul 2015 | rheumatoid arthritis | UCB Pharma | Completed | Missed primary |
| Phase 3 | NCT01519791 | Jan 2012 → Jul 2014 | rheumatoid arthritis | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT01374971 | Sep 2011 → Jul 2012 | rheumatoid arthritis | Nathan Wei, MD, FACP, FACR | Completed | No outcome recorded |
| Phase 3 | NCT01292265 | Feb 2011 → Jan 2012 | rheumatoid arthritis | UCB Pharma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02586246 | Jan 2011 → May 2013 | rheumatoid arthritis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01235598 | Dec 2010 → Sep 2012 | rheumatoid arthritis | UCB Pharma | Completed | Mixed |
| Phase 3 | NCT01213017 | Sep 2010 → Jan 2011 | rheumatoid arthritis | Oklahoma Medical Research Foundation | Completed | No outcome recorded |
| Phase 3 | NCT01087788 | Mar 2010 → Nov 2011 | psoriatic arthritis | UCB BIOSCIENCES, Inc. | Completed | Mixed |
| Phase 3 | NCT01087762 | Mar 2010 → Oct 2011 | spondyloarthropathy | UCB BIOSCIENCES, Inc. | Completed | Met primary |
| Phase 3 | NCT01197066 | Mar 2010 → Nov 2016 | rheumatoid arthritis | Korea Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00993317 | Oct 2009 → Aug 2011 | rheumatoid arthritis | Korea Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00850343 | Mar 2009 → May 2013 | rheumatoid arthritis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00851318 | Mar 2009 → Jun 2013 | rheumatoid arthritis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00843778 | Jan 2009 → Dec 2012 | rheumatoid arthritis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00791921 | Nov 2008 → Jan 2010 | rheumatoid arthritis | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT00753454 | Sep 2008 → May 2011 | rheumatoid arthritis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00717236 | Jul 2008 → Mar 2010 | rheumatoid arthritis | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT00674362 | Jun 2008 → May 2010 | rheumatoid arthritis | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT00552058 | Mar 2008 → Oct 2009 | Crohn disease | UCB Pharma | Completed | Missed primary |
| Phase 3 | NCT00358683 | Nov 2007 → ? | Crohn disease | UCB Pharma | Withdrawn | No outcome recorded |
| Phase 3 | NCT00307931 | Apr 2007 → Aug 2008 | Crohn disease | UCB Pharma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00354367 | Jan 2007 → ? | Crohn disease | UCB Pharma | Withdrawn | No outcome recorded |
| Phase 3 | NCT00356408 | Jan 2007 → Feb 2010 | Crohn disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00349752 | Nov 2006 → Jul 2009 | Crohn disease | UCB Pharma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00333788 | Oct 2006 → Apr 2010 | Crohn disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00308581 | Apr 2006 → Apr 2008 | Crohn disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00297648 | Feb 2006 → Jan 2008 | Crohn disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00160641 | Nov 2005 → Feb 2012 | rheumatoid arthritis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00160602 | Jun 2005 → Sep 2006 | rheumatoid arthritis | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT00175877 | Jun 2005 → Feb 2012 | rheumatoid arthritis | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT00152386 | Feb 2005 → Oct 2006 | rheumatoid arthritis | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT00160524 | Jul 2004 → Aug 2012 | Crohn disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00152425 | Feb 2004 → May 2005 | Crohn disease | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT00160706 | Feb 2004 → May 2012 | Crohn disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00152490 | Dec 2003 → May 2005 | Crohn disease | UCB Pharma | Completed | Mixed |
| Phase 3 | NCT00548834 | Jun 2003 → Jul 2004 | rheumatoid arthritis | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT00160693 | Mar 2003 → Feb 2011 | rheumatoid arthritis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00544154 | Oct 2002 → Jan 2004 | rheumatoid arthritis | UCB Pharma | Completed | Met primary |
| Phase 410 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 | NCT01443364 | Dec 2011 → May 2015 | rheumatoid arthritis | UCB Italy s.p.a. | 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 | Mixed |
| Phase 4 | NCT00993668 | Sep 2009 → Jun 2010 | rheumatoid arthritis | UCB Pharma | Completed | No outcome recorded |
| Phase 4 | NCT00580840 | Dec 2007 → Dec 2010 | 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 |
| Comparator or background therapy10 trials | ||||||
| Phase 2 | NCT02430909 Background | Apr 2015 → Apr 2017 | rheumatoid arthritis | UCB Celltech | Completed | Met primary |
| Phase 2 | NCT00899678 Comparator | Apr 2009 → Jul 2012 | Crohn disease | UCB Celltech | Terminated | No outcome recorded |
| 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 4 | NCT03100253 Comparator | Mar 2018 → Dec 2021 | rheumatoid arthritis | Mario Negri Institute for Pharmacological Research | Terminated | 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 |
| Phase 4 | NCT01500278 Comparator | Dec 2011 → Nov 2015 | rheumatoid arthritis | UCB Pharma | Completed | No outcome recorded |
| Phase 4 | NCT01024647 Comparator | Dec 2009 → May 2013 | Crohn disease | Atlanta Gastroenterology Associates | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-09-09 | UCB Pharma | Regulatory UCB receives U.S. FDA Breakthrough Therapy Designation for CIMZIA[®] (certolizumab pegol) in pregnant women with antiphospholipid syndrome (APS) ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to CIMZIA® (certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women who have antiphospholipid syndrome (APS) and are positive for lupus anticoagulant (LA). |
| 2026-06-05 | UCB Pharma | Results New EULAR 2026 data show CIMZIA[®] (certolizumab pegol) delivered consistent effect in rheumatoid arthritis, regardless of rheumatoid factor (RF) levels ucb.com ↗
In contrast, RF did not bind to Fc free certolizumab pegol, and no immune complex formation or cytokine induction was observed. |
| 2024-06-13 | UCB Pharma | Results New data support the value of CIMZIA[®] for women living with chronic rheumatic diseases throughout pregnancy and post-partum, and for people living with RA and high rheumatoid factor levels ucb.com ↗
Conversely, the RFs were unable to interact with certolizumab pegol, due to its lack of Fc domain, and no complexes with RF were formed. |
| 2023-11-11 | UCB Pharma | Results Post hoc analysis showed meaningful efficacy of certolizumab pegol for RA patients with high Rheumatoid Factor (RF) levels ucb.com ↗
A post hoc analysis from the EXXELERATE trial shows that 65.7 percent of certolizumab pegol-treated patients, and 48.3 percent of adalimumab-treated patients, with rheumatoid arthritis (RA) and high rheumatoid factor (RF) levels achieved low disease activity at Week 104 |
| 2021-06-01 | UCB Pharma | Results EULAR 2021: New Data from UCB’s Rheumatology Portfolio Demonstrates Real World Value for Patients with axSpA, PsA, and Women of Childbearing Age ucb.com ↗
Patients with axial spondyloarthritis (axSpA), who achieve sustained remission, benefit from continued CIMZIA[®] (certolizumab pegol) treatment either at the full or reduced maintenance dose, a post-hoc analysis of the C-OPTIMISE study confirms |
| 2015-04-23 | Astellas Pharma Inc | Results The Results of Japanese Clinical Trials of Anti-TNF-alpha Antibody Certolizumab Pegol were Announced at Leading Rheumatology Meeting 2015 in Japan astellas.com ↗
The additional analyses of C-OPERA, and long-term safety and efficacy over 4 years in J-RAPID and HIKARI studies were reported at the Annual General Assembly and Scientific Meeting of the Japan College of Rheumatology, April 23–25, 2015 in Nagoya, Japan. |
| 2014-11-19 | Astellas Pharma Inc | Results The results of Japanese Clinical Trials of Anti-TNF-alpha Antibody Certolizumab Pegol including new sub-group Analyses focusing on baseline patient characteristics were Announced at 2014 meeting of leading rheumatology meeting astellas.com ↗
In contrast, CZP + MTX co-therapy inhibited joint destruction even in patients with these characteristics compared to MTX monotherapy. |
| 2014-06-25 | Astellas Pharma Inc | Regulatory Announcement of an Application for the Additional Indication for the Anti-TNF-α Antibody Certolizumab Pegol (Generic Name) astellas.com ↗
they have filed an application for the additional indication. |
| 2012-12-25 | Astellas Pharma Inc | Regulatory Astellas and UCB announce approval of Cimzia®(certolizumab pegol) in Japan for the treatment of adult patients with rheumatoid arthritis astellas.com ↗
today announced that UCB Japan has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Cimzia® (INN;certolizumab pegol). |
| 2011-11-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results 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 ↗
Results of the two Japanese clinical trials, phase II/III J-RAPID Study and phase III HIKARI Study, showed treatment with certolizumab pegol was associated with a rapid and sustained reduction in RA signs and symptoms and inhibition of joint damage progression. |
| 2009-05-14 | Nektar Therapeutics | Regulatory Nektar Announces UCB's Cimzia(R) Approved by U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) confirmed today UCB's announcement that the US Food and Drug Administration (FDA) has approved Cimzia(R) (certolizumab pegol), the only PEGylated anti-TNFa (Tumor Necrosis Factor alpha), for the treatment of adult patients with moderately to severely active rheumatoid arthritis. |
| 2009-05-14 | XOMA (US) LLC | Regulatory XOMA Royalties On CIMZIA(r) Expected to Increase Due to FDA Approval for Moderate to Severe Rheumatoid Arthritis in Adults xoma.com ↗ |
| 2008-04-23 | Nektar Therapeutics | Regulatory FDA Approval of Cimzia(R) for Crohn's Disease Represents Latest Milestone for Nektar's PEGylation Technology Platform nektar.com ↗
The U.S. Food and Drug Administration (FDA) approved UCB's Cimzia(R) (certolizumab pegol) for reducing the signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy. |
All press releases naming this drug 25 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 106 sources stand behind the page.
| Field | Value | Cited 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 201392“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 ↗ |
| 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)” NCT00152425 ↗ “Certolizumab pegol (CDP870)” NCT00152386 ↗ “Certolizumab Pegol (CDP870)” NCT00152490 ↗ |
| 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 ↗7“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 ↗ “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 ↗ |
| 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 201420“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 ↗ “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 “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 “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 ↗ |
| 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 |