Certolizumab Pegol (Cimzia®)
| Disease area studied | Abbreviated title | Phase | Study ID | Registry database | Study results | Plain language summary | Publication (if available) |
|---|---|---|---|---|---|---|---|
| Axial Spondyloarthritis | Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis | Phase 3 |
AKS001
Completed |
NCT01087762 2009-011719-19 |
LINK LINK |
||
| Axial Spondyloarthritis | Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to | Phase 3 |
AS0005
Completed |
NCT02505542 2015-000339-34 |
LINK LINK |
Landewé R. et .Rheumatol Ther 2020; 7:581–99 | |
| Axial Spondyloarthritis | , , -controlled, Study to Evaluate and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-ray Evidence of (AS) and Objective Signs of Inflammation | Phase 3 |
AS0006
Completed |
NCT02552212 2015-001894-41 |
LINK LINK |
Deodhar A. et al. Arthritis Rheumatol 2019; 71(7):1101–11 | |
| Axial Spondyloarthritis | 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 | Phase 4 |
AS0007
Completed |
NCT03020992 2016-000343-14 |
LINK LINK |
van der Horst-Bruinsma I.E., et al. Therapeutic Advances in Musculoskeletal Disease 2021; 13:1-13 13:1759720X2110038 | |
| and Safety of CDP870 Versus in the Treatment of the Signs and Symptoms of | Phase 3 |
C87011
Completed |
NCT00548834 | Fleischmann et al. Ann Rheum Dis;2009;68(6);805-811 | |||
| and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With | Phase 3 |
C87014
Completed |
NCT00544154 | Choy et al. Rheumatology (Oxford);2012;51(7);1226-1234 | |||
| Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With | Phase 3 |
C87015
Completed |
NCT00160693 |
LINK
|
Fleischmann, R. et al. 2017; Rheumatol Ther 4 (1), pp. 57–69 | ||
| A Controlled Study to Assess and Safety of Certolizumab Pegol in the Treatment of | Phase 3 |
C87027
Completed |
NCT00152386 2004-002993-49 |
LINK
|
Keystone et al. Arthritis Rheum;2008;58(11);3319-3329 | ||
| A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of and in Prevention of Joint Damage in Patients With Active | Phase 3 |
C87028
Completed |
NCT00175877 2005-001350-24 |
LINK LINK |
Keystone, E. et al. Ann Rheum Dis;2014;73;12;2094-2100 | ||
| Crohn's Disease | A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug () | Phase 3 |
C87031
Completed |
NCT00152490 | Sandborn et al. N Engl J Med;2007;357(3);228-238 | ||
| Crohn's Disease | Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (), Following 3 Doses of Active Drug (CDP870). | Phase 3 |
C87032
Completed |
NCT00152425 | Schreiber et al. N Engl J Med;2007;357(3);239-250 | ||
| Crohn's Disease | A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] (PRECiSE 3) | Phase 3 |
C87033
Completed |
NCT00160524 |
LINK
|
Lichtenstein et al. Clin Gastroenterol Hepatol;2010;8(7);600-609 | |
| Crohn's Disease | A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease (PRECiSE 4) | Phase 3 |
C87034
Completed |
NCT00160706 |
LINK
|
Sandborn et al. Clin Gastroenterol Hepatol. 2010;8(8):696-702 | |
| Crohn's Disease | The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents (NURTURE) | Phase 2 |
C87035
Terminated |
NCT00899678 2014-004381-24 |
LINK LINK |
||
| Crohn's Disease | Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease | Phase 2 |
C87037
Completed |
NCT00291668 2014-004 399-42 |
LINK LINK |
Ogata et al. Gut. 2009;58(Suppl. II):A170. United European Gastroenterology Week 2009; November 21-25, 2009;London, UK. | |
| Study of CDP870 in Subjects With Chronic Plaque Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy | Phase 2 |
C87040
Completed |
NCT00245765 2005-002141-39 |
LINK LINK |
Reich et al. Br J Dermatol;2012;167(1);180-190 | ||
| Crohn's Disease | Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab | Phase 3 |
C87042
Completed |
NCT00308581 2005-004104-37 |
LINK LINK |
Sandborn et al. Clin Gastroenterol Hepatol;2010;8;8;688-695 | |
| Crohn's Disease | Mucosal Healing Study in Crohn's Disease (CD) (MUSIC) | Phase 3 |
C87043
Completed |
NCT00297648 2005-003977-25 |
LINK LINK |
Hébuterne et al. Gut;2013;62(2);201-208 | |
| of Re-treatment With Cimzia® in Subject With Chronic Plaque | Phase 2 |
C87044
Completed |
NCT00329303 2005-005525-63 |
LINK LINK |
Reich et al. Br J Dermatol;2012;167(1);180-190 | ||
| Crohn's Disease | Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease (Welcome2) | Phase 3 |
C87046
Completed |
NCT00333788 2006-001729-24 |
LINK LINK |
||
| Crohn's Disease | Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease | Phase 2 |
C87047
Completed |
NCT00329550 2014-004354-34 |
LINK LINK |
Ogata et al. Gut. 2009;58(Suppl. II):A170. United European Gastroenterology Week 2009; November 21-25, 2009;London, UK. | |
| Crohn's Disease | Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668) | Phase 2 |
C87048
Completed |
NCT00329420 2014-004400-30 |
LINK LINK |
Ogata et al. Gut. 2009;58(Suppl. II):A170. United European Gastroenterology Week 2009; November 21-25, 2009;London, UK. | |
| A Study of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of and in Prevention of Joint Damage in Patients With Active | Phase 3 |
C87050
Completed |
NCT00160602 2005-002326-63 |
LINK
|
Smolen et al. Ann Rheum Dis;2009;68(6);797-804 | ||
| A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of and in Prevention of Joint Damage in Patients With Active | Phase 3 |
C87051
Completed |
NCT00160641 2005-002629-30 |
LINK LINK |
Bykerk et al. Rheumatol Ther 2023; 10 (3), pp. 693–706 | ||
| Crohn's Disease | Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab | Phase 3 |
C87055
Terminated |
NCT00307931 2006-002027-16 |
LINK LINK |
Triantafillidis et al. Am J Gastroenterol 2010;105(S1):S417. American College of Gastroenterology (ACG) 2010. October 15-20, 2010; San Antonio, USA. | |
| Crohn's Disease | Evaluate of Certolizumab in Crohn's Patients With Draining Fistulas | Phase 4 |
C87058
Terminated |
NCT00354367 | |||
| Crohn's Disease | Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease (COSPAR1) | Phase 3 |
C87059
Terminated |
NCT00349752 2006-003870-88 |
LINK LINK |
||
| Crohn's Disease | Examining the Long Term Safety, , and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II) | Phase 3 |
C87065
Completed |
NCT00356408 2006-003871-11 |
LINK LINK |
||
| (RA) Moderate to Low Disease Activity Study (CERTAIN) | Phase 3 |
C87076
Completed |
NCT00674362 2007-000828-40 |
LINK LINK |
Smolen, J. S. et al. Ann Rheum Dis;2015;74;5;843-850 | ||
| Dosing Flexibility Study in Patients With (DoseFlex) | Phase 3 |
C87077
Completed |
NCT00580840 2007-005288-86 |
LINK LINK |
Furst, D. E. et al. Arthritis Care Res;2015;67;2;151-160 | ||
| Follow-up of (RA) Moderate to Low Disease Activity Study (CERTAIN 2) | Phase 3 |
C87080
Completed |
NCT00843778 2007-000830-38 |
LINK LINK |
Smolen, J. S. et al. Ann Rheum Dis;2015;74;5;843-850 | ||
| Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With (RA) (Dose Flex II) | Phase 3 |
C87084
Completed |
NCT00753454 |
LINK
|
Furst, D. E. et al. Arthritis Care Res;2015;67;2;151-160 | ||
| Crohn's Disease | Study to Evaluate and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease | Phase 3 |
C87085
Completed |
NCT00552058 2007-001913-41 |
LINK LINK |
Sandborn et al. Clin Gastroenterol Hepatol;2011;9(8);670-678 | |
| Crohn's Disease | A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease | Phase 3 |
C87088
Completed |
NCT00552344 2007-002716-26 |
LINK LINK |
Sandborn, W. J. et al. Gastroenterology;2011;140;5 Suppl. 1;S-262 Digestive Disease Week (DDW) 2011, May 7-10, 2011;Chicago, US | |
| Certolizumab Pegol for the Treatment of Patients With Active (REALISTIC) | Phase 3 |
C87094
Completed |
NCT00717236 2008-005427-28 |
LINK LINK |
Weinblatt et al. Rheumatology (Oxford);2012;51(12);2204-2214 | ||
| Crohn's Disease | Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol | Phase 2 |
CR0012
Completed |
NCT01190410 2017-005025-20 |
LINK LINK |
||
| Study to Evaluate the and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque (PSO) | Phase 3 |
PS0002
Completed |
NCT02326272 2014-003486-14 |
LINK LINK |
Gottlieb A.B. et al. J Am Acad Dermatol 2018; 79(2):302–314 | ||
| and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and in Subjects With Plaque (PSO) (CIMPACT) | Phase 3 |
PS0003
Completed |
NCT02346240 2014-003492-36 |
LINK LINK |
Lebwohl, M. et al J Am Acad Dermatol 2018; 79(2):266–76 Warren R.B., Lebwohl M., Sofen H., Piguet V., Augustin M. et al.J Eur Acad Dermatol Venereol 2021; 35:2398–408 | ||
| An and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque (PSO) | Phase 3 |
PS0005
Completed |
NCT02326298 2014-003513-28 |
LINK
|
Gottlieb A.B., J Am Acad Dermatol 2018; 79(2):302–314 | ||
| The purpose of the study is to demonstrate the and safety of certolizumab pegol in the treatment of moderate to severe chronic plaque in study participants aged 6 to 11 and 12 to 17 years. | Phase 3 |
PS0007
Ongoing |
NCT04123795 | Gottlieb A.B. et al. J Am Acad Dermatol 2018; 79(2):302–314. Gordon K.R. Brit J Dermatol 2021; 184(4):652-62 | |||
| A Study to Test the and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic | Phase 2/3 |
PS0017
Completed |
NCT03051217 |
LINK
|
Umezawa Y. et al. Dermatology and therapy 2021, 11(2):513-528 Imafuku S. et al. Dermatol Ther (Heidelb) 2022; 12:121-135 Umezawa Y. et al. Dermatology and therapy 2021; 11(3):943–60 | ||
| Certolizumab Pegol in Subjects With Adult Onset Active and Progressive | Phase 3 |
PSA001
Completed |
NCT01087788 2009-011720-59 |
LINK LINK |
Mease PJ, et al. Ann Rheum Dis. 2014 Jan;73(1):48-55 | ||
| Assessing the Use of Certolizumab Pegol in Adult Subjects With on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines | Phase 4 |
RA0017
Completed |
NCT00993668 |
LINK
|
Kivitz et al. J Rheumatol;2014;41(4);648-657 | ||
| Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active (RA) (MARVELOUS) | Phase 3 |
RA0028
Completed |
NCT01235598 2009-013758-33 |
LINK LINK |
Ostergaard, M. et al. Ann Rheum Dis;2015;74;1156-1163 | ||
| A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With (RA) (SWIFT) | Phase 3 |
RA0033
Terminated |
NCT01292265 |
LINK
|
Bykerk V.P., et al. DataRheumatol Ther 2023; 10(3):693–706 | ||
| Pediatric Arthritis Study of Certolizumab Pegol (PASCAL) | Phase 3 |
RA0043
Completed |
NCT01550003 [2009-018027-33 |
LINK LINK |
Brunner H.I., Ruperto N., Keltsev V., Alexeeva E., Abud-Mendoza C. et al. Arthritis Rheum 2016; 68(Suppl S10) abs 947; 80th Annual Meeting of American College of Rheumatology (ACR) and 51th Annual Meeting of Association of Rheumatology Health Professionals (ARHP), November 11-15, 2016; Washington, DC, USA | ||
| A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active (RAPID-C) | Phase 3 |
RA0044
Completed |
NCT02151851 |
LINK
|
Bi L. et al. Clin Exp Rheumatol 2019; 37(2):227–34 | ||
| A Multi-center, , , -controlled Study to Evaluate the and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active (C-early) | Phase 3 |
RA0055
Completed |
NCT01519791 2011-001729-25 |
LINK LINK |
Emery et al., Ann Rheum Dis 2016; 76(1):96-104 | ||
| A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Subjects (PREDICT) | Phase 4 |
RA0064
Completed |
NCT01255761 |
LINK
|
Curtis, J. R. et al. Arthritis Rheumatol;Arthritis Rheumatol;2015;67(12):3104-3112 | ||
| Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With (SPEED) | Phase 4 |
RA0069
Completed |
NCT01443364 2011-000385-35 |
LINK LINK |
Sarzi-Puttini et al. Ann Rheum Dis;2016;75;Suppl 2;236 - EULAR 2016 Annual European Congress of Rheumatology; 08-11 June, 2016;London, UK | ||
| Study to Assess the Short- and Long-term of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe (RA) Inadequately Responding to Methotrexate | Phase 4 |
RA0077
Completed |
NCT01500278 2011-002067-20 |
LINK LINK |
Smolen et al., Lancet 2016, 388/100361, 2763-2774 | ||
| An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Who Enrolled in RA0044 (RAPID-C OLE) | Phase 3 |
RA0078
Completed |
NCT02319642 |
LINK
|
Bi L. et al. Int J Rheum Dis 2018; 21(S1):184 - APLAR 2018; Kaohsiung, Taiwan | ||
| Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active , Active , Active , or Moderately to Severely Active | Phase 3 |
RA0098
Completed |
NCT03357471 |
LINK
|
Tatla D., Mountian I., Szegvari B., VanLunen B., Schiff M. Expert Opinion on Drug Delivery 2020; 17(6):855-62 | ||
| A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active | Phase 1 |
RA0138
Completed |
NCT04740814 |
LINK
|
|||
| Axial Spondyloarthritis (AxSpA) Non-radiographic Evidence-AxSpA Crohn's Disease | A , Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol) | Phase 1 |
UP0016
Completed |
NCT02154425 |
LINK
|
Clowse M.E.B.,et al Ann Rheum Dis 2017; 76(11):1890–6 | |
| Axial Spondyloarthritis (AxSpA) Non-radiographic Evidence-AxSpA Crohn's Disease | A Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol) | Phase 1 |
UP0017
Completed |
NCT02019602 2013-003812-30 |
LINK
|
Mariette X., et al. Ann Rheum Dis 2018; 77(2):228–33 | |
| Chronic inflammatory diseases | A study in pregnant women with chronic inflammatory diseases treated with Cimzia (certolizumab pegol) | Phase 1 |
UP0085
Completed |
NCT04163016 |
LINK
|
Menshykau D., et al. CPT Pharmacometrics Syst Pharmacol 2024; 13(11):1904–14 |