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Certolizumab Pegol (Cimzia®)
Clinical Study Information - Cimzia® (certolizumab pegol)
| 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 |
AKS001 Completed |
NCT01087762 2009-011719-19 |
LINK LINK |
Landewé et al. Ann Rheum Dis;2014; 73(1);39-47. Braun J. et al. RMD open 2017; 3(e000430) |
||
| Axial Spondyloarthritis | Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo |
AS0005 Completed |
NCT02505542 |
|
Landewé R. et al. Rheumatol Ther 2020, epub Braun J. et al. RMD open 2017; 3(e000430) |
||
| 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 |
AS0006 Completed |
NCT02552212 2015-001894-41 |
|
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 |
AS0007 Completed |
NCT03020992 |
LINK |
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| Rheumatoid Arthritis | Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis |
C87011 Completed |
NCT00548834 |
PDF
|
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 |
C87014 Completed |
NCT00544154 |
PDF
|
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 |
C87015 Completed |
NCT00160693 |
LINK |
Fleischmann et al. Ann Rheum Dis. 2012;71(Suppl.3): 523.European League Against Rheumatism (EULAR) 2012. June 6-9, 2012; Berlin, Germany.. | ||
| Rheumatoid Arthritis | A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis |
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 |
C87028 Completed |
NCT00175877 2005-001350-24 |
LINK LINK |
Keystone, E. C. et al. Rheumatology (Oxford);2012;51;9;1628-1638 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) |
C87031 Completed |
NCT00152490 |
PDF
|
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). |
C87032 Completed |
NCT00152425 |
PDF
|
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) |
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) |
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) |
C87035 Terminated |
NCT00899678 2014-004381-24 |
LINK LINK |
|
||
| Crohn's Disease | Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease |
C87037 Completed |
NCT00291668 2014-004399-42 |
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 Phototherapy Photochemotherapy |
C87040 Completed |
NCT00245765 2005-002141-39 |
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 |
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) |
C87043 Completed |
NCT00297648 2005-003977-25 |
LINK LINK |
Hébuterne et al. Gut;2012;62(2);201-208. | ||
| Psoriasis | Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis |
C87044 Completed |
NCT00329303 2005-005525-63 |
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) |
C87046 Completed |
NCT00333788 |
LINK LINK |
Feagan et al. Inflamm Bowel Dis. 2013;19(suppl.1): S82, abs P-145. Crohn's & Colitis Foundation of America (CCFA) Advances in Inflammatory Bowel Diseases 2013, December 12-14, 2013; Hollywood, USA. |
||
| Crohn's Disease | Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease |
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) |
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 |
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 |
C87051 Completed |
NCT00160641 2005-002629-30 |
LINK LINK |
Smolen et al. Rheumatology. 2011;50(Suppl 3): iii123, abs 210. British Society for Rheumatology Annual Meeting 2011. April 12-14,2011;Brighton, UK. |
||
| Crohn's Disease | Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab |
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 |
C87058 Terminated |
NCT00354367 | ||||
| Crohn's Disease | Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease (COSPAR1) |
C87059 Terminated |
NCT00349752 |
LINK LINK |
|||
| Crohn's Disease | Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II) |
C87065 Completed |
NCT00356408 |
LINK LINK |
|||
| Rheumatoid Arthritis | Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study (CERTAIN) |
C87076 Completed |
NCT00674362 |
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) |
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) |
C87080 Completed |
NCT00843778 |
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) |
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 |
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 |
C87088 Completed |
NCT00552344 |
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) |
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 |
CR0012 Completed |
NCT01190410 |
|
|||
| Psoriasis | Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) |
PS0002 Completed |
NCT02326272 2014-003486-14 |
LINK LINK |
Gottlieb A.B. et al. J Am Acad Dermatol 2018; 79(2):302–314. Gordon K.R. Brit J Dermatol 2020, epub
|
||
| Psoriasis | Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) (CIMPACT) |
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 [ePub] |
||
| Psoriasis | An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) |
PS0005 Completed |
NCT02326298 2014-003513-28 |
LINK |
Gottlieb A.B., J Am Acad Dermatol 2018; 79(2):302–314.
Gordon KR, Br J Dermatol 2020, epub |
||
| 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. |
PS0007 Ongoing |
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 |
PS0017 Completed |
NCT03051217 |
|
Umezawa Y., Sakurai S., Hoshii N., Nakagawa H. Dermatology and therapy 2021 [aheadofprint] | ||
| Psoriatic Arthritis | Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis |
PSA001 Completed |
NCT01087788 |
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 |
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) |
RA0028 Completed |
NCT01235598 |
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) |
RA0033 Terminated |
NCT01292265 |
LINK |
|||
| Rheumatoid Arthritis | Pediatric Arthritis Study of Certolizumab Pegol (PASCAL) |
RA0043 Ongoing |
NCT01550003 | Brunner H.I., Ruperto N., Keltsev V., Alexeeva E., Abud-Mendoza C. et al. Arthritis Rheum 2016; 68(Suppl S10) abs 947 | |||
| Rheumatoid Arthritis | A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis (RAPID-C) |
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) |
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) |
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) |
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 |
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) |
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-Devicefor 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 |
RA0098 Completed |
LINK |
Tatla D., Mountian I., Szegvari B., VanLunen B., Schiff M. Expert Opinion on Drug Delivery 2020 [ePub] | |||
| Rheumatoid Arthritis | A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis |
RA0138 Ongoing |
|||||
| 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) |
UP0016 Completed |
|
|
Clowse M.E.B.,et al Ann Rheum Dis 2017; 76(11):1890–6 |
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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 Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol) |
UP0017 Completed |
|
|
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) |
UP0085 Ongoing |
NCT04163016 |