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 |
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| Axial Spondyloarthritis | Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo | Phase 3 |
AS0005
Completed |
NCT02505542 2015-000339-34 |
LINK LINK |
Landewé R. et .Rheumatol Ther 2020; 7:581–99 | |
| Axial Spondyloarthritis | Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-ray Evidence of Ankylosing Spondylitis (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., van Bentum R.E., Verbraak F.D., Deodhar A., Rath T. et al. Therapeutic Advances in Musculoskeletal Disease 2021; 13:1-13 13:1759720X2110038 | |
| Rheumatoid Arthritis | Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis | Phase 3 |
C87011
Completed |
NCT00548834 | Fleischmann et al. Ann Rheum Dis;2009;68(6);805-811 | ||
| Rheumatoid Arthritis | Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis | Phase 3 |
C87014
Completed |
NCT00544154 | Choy et al. Rheumatology (Oxford);2012;51(7);1226-1234. | ||
| Rheumatoid Arthritis | Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis | Phase 3 |
C87015
Completed |
NCT00160693 |
LINK
|
Fleischmann, R. et al. 2017; Rheumatol Ther 4 (1), pp. 57–69. | |
| Rheumatoid Arthritis | A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis | Phase 3 |
C87027
Completed |
NCT00152386 2004-002993-49 |
LINK
|
Keystone et al. Arthritis Rheum;2008;58(11);3319-3329 | |
| Rheumatoid Arthritis | A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis | 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 (Placebo) | 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 (Placebo), 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 Double-blind 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. | |
| Psoriasis | Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis 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 | |
| Psoriasis | Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis | 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. | |
| Rheumatoid Arthritis | A Study of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis | Phase 3 |
C87050
Completed |
NCT00160602 2005-002326-63 |
LINK
|
Smolen et al. Ann Rheum Dis;2009;68(6);797-804. | |
| Rheumatoid Arthritis | A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis | 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 Efficacy 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, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II) | Phase 3 |
C87065
Completed |
NCT00356408 2006-003871-11 |
LINK LINK |
||
| Rheumatoid Arthritis | Rheumatoid Arthritis (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 | |
| Rheumatoid Arthritis | Dosing Flexibility Study in Patients With Rheumatoid Arthritis (DoseFlex) | Phase 3 |
C87077
Completed |
NCT00580840 2007-005288-86 |
LINK LINK |
Furst, D. E. et al. Arthritis Care Res;2015;67;2;151-160 | |
| Rheumatoid Arthritis | Follow-up of Rheumatoid Arthritis (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 | |
| Rheumatoid Arthritis | Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (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 Efficacy 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 | |
| Rheumatoid Arthritis | Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (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 |
||
| Psoriasis | Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (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. | |
| Psoriasis | Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (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 | |
| Psoriasis | An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) | Phase 3 |
PS0005
Completed |
NCT02326298 2014-003513-28 |
LINK
|
Gottlieb A.B., J Am Acad Dermatol 2018; 79(2):302–314. | |
| Psoriasis | The purpose of the study is to demonstrate the efficacy and safety of certolizumab pegol in the treatment of moderate to severe chronic plaque psoriasis 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 | ||
| Psoriasis | A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis | 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 | |
| Psoriatic Arthritis | Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis | Phase 3 |
PSA001
Completed |
NCT01087788 2009-011720-59 |
LINK LINK |
Mease et al. Ann Rheum Dis;2014;73(1);48-55 | |
| Rheumatoid Arthritis | Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis 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 | |
| Rheumatoid Arthritis | Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA) (MARVELOUS) | Phase 3 |
RA0028
Completed |
NCT01235598 2009-013758-33 |
LINK LINK |
Ostergaard, M. et al. Ann Rheum Dis;2015;74;1156-1163 | |
| Rheumatoid Arthritis | A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA) (SWIFT) | Phase 3 |
RA0033
Terminated |
NCT01292265 |
LINK
|
Bykerk V.P., et al. DataRheumatol Ther 2023; 10(3):693–706 | |
| Rheumatoid Arthritis | 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 N/A | |
| Rheumatoid Arthritis | A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis (RAPID-C) | Phase 3 |
RA0044
Completed |
NCT02151851 |
LINK
|
Bi L. et al. Clin Exp Rheumatol 2019; 37(2):227–34 | |
| Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis (C-early) | Phase 3 |
RA0055
Completed |
NCT01519791 2011-001729-25 |
LINK LINK |
Emery et al., Ann Rheum Dis 2016; 76(1):96-104 | |
| Rheumatoid Arthritis | A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects (PREDICT) | Phase 4 |
RA0064
Completed |
NCT01255761 |
LINK
|
Curtis, J. R. et al. Arthritis Rheumatol;Arthritis Rheumatol;2015;67(12):3104-3112 | |
| Rheumatoid Arthritis | Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis (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 | |
| Rheumatoid Arthritis | Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate | Phase 4 |
RA0077
Completed |
NCT01500278 2011-002067-20 |
LINK LINK |
Smolen et al., Lancet 2016, 388/100361, 2763-2774 | |
| Rheumatoid Arthritis | An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis 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 | |
| Rheumatoid Arthritis | 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 Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn’s Disease | 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 | |
| Rheumatoid Arthritis | A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis | Phase 1 |
RA0138
Completed |
NCT04740814 |
LINK
|
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| Axial Spondyloarthritis (AxSpA) Non-radiographic Evidence-AxSpA Ankylosing Spondylitis Crohn's Disease Psoriatic Arthritis Rheumatoid Arthritis | A Multicenter, 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 Ankylosing Spondylitis Crohn's Disease Psoriatic Arthritis Rheumatoid Arthritis | A Multicenter 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
|
Clowse, M. et al. 2024; Ann Rheum Dis 83 (Suppl 1), pp. 1145–1146. EULAR European Congress of Rheumatology (EULAR), June 12-15, 2024; Vienna, Austria. |