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Our Science Our clinical studies Certolizumab Pegol (Cimzia®)

Clinical Study Information - Cimzia® (certolizumab pegol)

Disease area
studied
Abbreviated title Phase Study ID Registry database Study results Study summary Publication (if available)
Axial Spondyloarthritis Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis Phase 3 AKS001
Completed
NCT01087762
2009-011719-19
LINK
LINK
PDF 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  Phase 3 AS0005
Ongoing
NCT02505542
 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
Ongoing
NCT02552212
2015-001894-41
 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
Ongoing
NCT03020992
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 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 Phase 3 C87014
Completed
NCT00544154 PDF
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 Phase 3 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 Phase 3 C87027
Completed
NCT00152386
2004-002993-49
PDF

LINK
PDF Keystone et al. Arthritis Rheum; 2008;58(11);3319-3329.
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
PDF

LINK
PDF 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. 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) Phase 3 C87031
Completed
NCT00152490 PDF
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). Phase 3 C87032
Completed
NCT00152425 PDF
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) 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
2014-004399-42
PDF

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 Phase 2 C87040
Completed
NCT00245765
2005-002141-39
PDF

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;2012;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
PDF

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 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 Phase 2 C87047
Completed
NCT00329550
2014-004354-34
LINK
LINK
PDF 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
PDF

LINK
PDF 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

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 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 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 LINK
LINK

Rheumatoid Arthritis Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study (CERTAIN) Phase 3 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) 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 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 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
 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
Ongoing
NCT02326272
2014-003486-14
Psoriatic Arthritis Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis Phase 3 PSA001
Completed
NCT01087788 LINK
LINK

PDF Mease et al. Ann Rheum Dis; 2014; 73(1);48-55.
Psoriasis Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) (CIMPACT) Phase 3 PS0003
Ongoing
NCT02346240
2014-003492-36
Psoriasis An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) Phase 3 PS0005
Ongoing
NCT02326298
2014-003513-28
Psoriasis  A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis Phase 2 PS0017
Ongoing
NCT03051217
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 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
Rheumatoid Arthritis Pediatric Arthritis Study of Certolizumab Pegol (PASCAL) Phase 3 RA0043
Ongoing
NCT01550003
Rheumatoid Arthritis A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis (RAPID-C) Phase 3 RA0044
Completed
NCT02151851
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
PDF 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