Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis

NCT ID: NCT00329303

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-05-31

Brief Summary

The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 [NCT00245765] and Week 12 of re-treatment in this study.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Certolizumab Pegol (CZP) 200 mg

Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter.

Group Type: EXPERIMENTAL

Certolizumab Pegol (Cimzia®)

Intervention Type: DRUG

• Pharmaceutical Form: Solution for injection in pre-filled syringe
• Route of Administration: Subcutaneous use
• Dose and Administration details :

2 x 1 mL Certolizumab Pegol at Week 0, followed by

• 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10
• 2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10

Certolizumab Pegol (CZP) 400 mg

Subcutaneous injections of 400 mg every 2 weeks.

Group Type: EXPERIMENTAL

Certolizumab Pegol (Cimzia®)

Intervention Type: DRUG

• Pharmaceutical Form: Solution for injection in pre-filled syringe
• Route of Administration: Subcutaneous use
• Dose and Administration details :

2 x 1 mL Certolizumab Pegol at Week 0, followed by

• 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10
• 2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10

Interventions

Certolizumab Pegol (Cimzia®)

• Pharmaceutical Form: Solution for injection in pre-filled syringe
• Route of Administration: Subcutaneous use
• Dose and Administration details :

2 x 1 mL Certolizumab Pegol at Week 0, followed by

• 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10
• 2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject having responded to treatment at Week 12 in study C87040 and having relapsed during the follow-up period
• Female subjects either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practising an acceptable method of contraception.Subjects agreed to continue using adequate contraception during the study and for 12 weeks after the last dose of CDP870

Exclusion Criteria

• Subjects with erythrodermic, guttate, generalized pustular form of psoriasis
• Any recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
• Positive hepatitis B surface antigen test and /or hepatitis C antibody test results
• Positive human immunodeficiency virus (HIV) test result
• White blood cell counts less than 4000 per cubic millimeter or more than 20000 per cubic millimeter
• Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
• Systemic Lupus Erythematosus
• Participation in a clinical study within the past 3 months except Study C87040
• Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

UCB Pharma

Locations

Besançon, , France

Créteil, , France

Nice, , France

Paris, , France

Pierre-Bénite, , France

Berlin, , Germany

Bonn, , Germany

Essen, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Kiel, , Germany

Mahlow, , Germany

Mainz, , Germany

Münster, , Germany

Countries

France; Germany

References

Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.

Reference Type: RESULT

PMID: 22413944 (View on PubMed)

Other Identifiers

2005-005525-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C87044

Identifier Type: -

Identifier Source: org_study_id