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 NCT010877622009-011719-19 LINKLINK PDF Axial Spondyloarthritis Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo Phase 3 AS0005 Completed NCT025055422015-000339-34 LINKLINK 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 NCT025522122015-001894-41 LINKLINK 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 NCT030209922016-000343-14 LINKLINK 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 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, 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 NCT001523862004-002993-49 LINK PDF 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 NCT001758772005-001350-24 LINKLINK 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 NCT008996782014-004381-24 LINKLINK Crohn's Disease Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease Phase 2 C87037 Completed NCT002916682014-004399-42 LINKLINK PDF 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 NCT002457652005-002141-39 LINKLINK PDF 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 NCT003085812005-004104-37 LINKLINK 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 NCT002976482005-003977-25 LINKLINK 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 NCT003293032005-005525-63 LINKLINK PDF 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 NCT003337882006-001729-24 LINKLINK Crohn's Disease Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease Phase 2 C87047 Completed NCT003295502014-004354-34 LINKLINK 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 NCT003294202014-004400-30 LINKLINK 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 NCT001606022005-002326-63 LINK PDF 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 NCT001606412005-002629-30 LINKLINK 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 NCT003079312006-002027-16 LINKLINK 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 NCT003497522006-003870-88 LINKLINK 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 NCT003564082006-003871-11 LINKLINK Rheumatoid Arthritis Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study (CERTAIN) Phase 3 C87076 Completed NCT006743622007-000828-40 LINKLINK 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 NCT005808402007-005288-86 LINKLINK PDF 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 NCT008437782007-000830-38 LINKLINK 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 NCT005520582007-001913-41 LINKLINK 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 NCT005523442007-002716-26 LINKLINK 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 NCT007172362008-005427-28 LINKLINK 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 NCT011904102017-005025-20 LINKLINK 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 NCT023262722014-003486-14 LINKLINK PDF PDF 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 NCT023462402014-003492-36 LINKLINK PDF PDF 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 NCT023262982014-003513-28 LINK PDF PDF 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 NCT010877882009-011720-59 LINKLINK PDF PDF 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 NCT012355982009-013758-33 LINKLINK 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 LINKLINK PDF 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 PDF PDF 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 NCT015197912011-001729-25 LINKLINK PDF 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 NCT014433642011-000385-35 LINKLINK 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 NCT015002782011-002067-20 LINKLINK 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 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 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 PDF PDF 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 NCT020196022013-003812-30 LINK PDF PDF 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 PDF 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.
