NCT00245765

Brief Summary

A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_2

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
12.5 years until next milestone

Results Posted

Study results publicly available

May 3, 2019

Completed
Last Updated

May 3, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

October 26, 2005

Results QC Date

June 22, 2018

Last Update Submit

January 29, 2019

Conditions

Chronic Plaque Psoriasis

Keywords

chronic plaque psoriasis, anti TNFαCDP870, Cimzia

Outcome Measures

Primary Outcomes (2)

  • Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12

    Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI75 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 75 %.

    Week 12

  • Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12

    The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)

    Week 12

Secondary Outcomes (9)

  • Time to Psoriasis Activity and Severity Index 50 (PASI50)

    During the 12-weeks Treatment Period

  • Time to Psoriasis Activity and Severity Index 75 (PASI75)

    During the 12-weeks Treatment Period

  • Time to Relapse

    During the 12-weeks Treatment Period

  • Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12

    Week 12

  • Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12

    Week 12

  • +4 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subcutaneous injections of Placebo every 2 weeks

Other: Placebo

Certolizumab Pegol 200 mg

EXPERIMENTAL

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

Drug: Certolizumab Pegol

Certolizumab Pegol 400 mg

EXPERIMENTAL

Subcutaneous injections of 400 mg every 2 weeks

Drug: Certolizumab Pegol

Interventions

Certolizumab PegolDRUG

* Pharmaceutical Form: solution for injection in pre-filled syringe * Route of Administration: subcutaneous use

Also known as: Cimzia
Certolizumab Pegol 200 mgCertolizumab Pegol 400 mg
PlaceboOTHER

Matching Placebo to Certolizumab Pegol

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult men and women \> 18 years
  • Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
  • Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area (BSA) ≥ 10 %
  • Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy

You may not qualify if:

  • Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
  • A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough);
  • White blood cell counts less than 4000/mm\^3 or more than 20000/mm\^3
  • Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
  • Systemic Lupus
  • Non respect of adequate wash out periods for treatments that might have an impact on the disease
  • Any associated disease that could be impacted by the study treatment intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Besançon, France

Location

Unknown Facility

Créteil, France

Location

Unknown Facility

Nice, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Pierre-Bénite, France

Location

Unknown Facility

Saint-Etienne, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Essen, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Göttingen, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Mainz, Germany

Location

Unknown Facility

Münster, Germany

Location

Related Publications (9)

  • Ortonne JP, Tasset C, Reich K. Efficacy of certolizumab pegol, a PEGylated Fab' fragment of an anti-alpha monoclonal antibody, in patients previously exposed to biologicals: preliminary results of a randomised, placebo-controlled, phase II clinical trial in psoriasis. J.Eur.Acad.Dermatol.Venereol. 22[Suppl 1], 2007. Vienna, 16th Congress of the European Academy of Dermatology and Venereology (EADV), May 16-20, 2007.

    RESULT

  • Ortonne JP, Sterry W, Tasset C, Reich K. Safety and efficacy of subcutaneous certolizumab pegol, a new anti-TNF-alpha monoclonal antibody, in patients with moderate-to-severe chronic plaque psoriasis: preliminary results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 56[Suppl 2], AB6. 2007. Washington, DC, 65th Annual Meeting of the American Academy of Dermatology (AAAD), February 2-7, 2007.

    RESULT

  • Reich K, Tasset C, Ortonne J. Efficacy and safety of certolizumab pegol, in patients with chronic plaque psoriasis: preliminary results of a randomized, double-blind, placebo-controlled trial. Ann.Rheum.Dis. 66[Suppl 2], 251. 2007. Barcelona, Annual European Congress of Rheumatology EULAR 2007, June 13-16, 2007.

    RESULT

  • Ortonne JP, Sterry W, Tasset C, Reich K. Certolizumab pegol, the first pegylated anti-TNF alpha, is effective and well tolerated in patients with moderate-to-severe chronic plaque psoriasis: preliminary data from a phase II study. J.Eur.Acad.Dermatol.Venereol. 21[Suppl 1], 26. 2007. Rhodes, Greece, 15th Congress of the European Academy of Dermatology and Venereology (EADV), October 4-8, 2006.

    RESULT

  • Ortonne JP, Sterry W, Coteur G, Keininger DL, Reich K. Improved health-related quality of life in psoriasis patients following 10 weeks' treatment with certolizumab pegol: data from a Phase II study. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

    RESULT

  • Reich K, Sterry W, Tasset C, Terpstra I, Ortonne JP. Efficacy and time to relapse with certolizumab pegol, the first pegylated anti-TNF alpha agent, in patients with moderate-to-severe chronic plaque psoriasis: Phase II study results. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

    RESULT

  • Ortonne JP, Reich K, Sterry W, Terpstra I. Safety and efficacy (PASI 90 and global evaluation) of subcutaneous certolizumab pegol in patients with moderate to severe chronic plaque psoriasis: Results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 58[Suppl 2], AB4. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

    RESULT

  • Ortonne JP, Reich K, Keininger DL. Certolizumab pegol improved health-related quality of life in patients with psoriasis: Data from a phase II study. J.Am.Acad.Dermatol. 58[Suppl 2], AB121. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

    RESULT

  • 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.

    PMID: 22413944RESULT

MeSH Terms

Interventions

Certolizumab Pegol

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsPolymersMacromolecular SubstancesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
UCB
Organization
Cares
UCBCares@ucb.com
+1844 599

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 28, 2005

Study Start

October 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

May 3, 2019

Results First Posted

May 3, 2019

Record last verified: 2019-01

Locations

DE(9)FR(6)