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Trial record 1 of 2 for:    NCT00245765
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Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy

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ClinicalTrials.gov Identifier: NCT00245765
Recruitment Status : Completed
First Posted : October 28, 2005
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by:
UCB Pharma

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.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: Certolizumab Pegol Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy
Study Start Date : October 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Placebo
Subcutaneous injections of Placebo every 2 weeks
Other: Placebo
Matching Placebo to Certolizumab Pegol

Experimental: Certolizumab Pegol 200 mg
Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Drug: Certolizumab Pegol
  • Pharmaceutical Form: solution for injection in pre-filled syringe
  • Route of Administration: subcutaneous use
Other Name: Cimzia

Experimental: Certolizumab Pegol 400 mg
Subcutaneous injections of 400 mg every 2 weeks
Drug: Certolizumab Pegol
  • Pharmaceutical Form: solution for injection in pre-filled syringe
  • Route of Administration: subcutaneous use
Other Name: Cimzia




Primary Outcome Measures :
  1. Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12 [ Time Frame: 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 %.


  2. Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12 [ Time Frame: 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)



Secondary Outcome Measures :
  1. Time to Psoriasis Activity and Severity Index 50 (PASI50) [ Time Frame: During the 12-weeks Treatment Period ]

    Time to PASI50 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI50 during the Treatment Period.

    This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).


  2. Time to Psoriasis Activity and Severity Index 75 (PASI75) [ Time Frame: During the 12-weeks Treatment Period ]

    Time to PASI75 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI75 during the Treatment Period.

    This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).


  3. Time to Relapse [ Time Frame: During the 12-weeks Treatment Period ]
    Time to relapse is defined as the time elapsed between the last dose and when maximal improvement in PASI from Baseline was reduced by > 50 %. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).

  4. Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 [ Time Frame: 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.

    PASI50 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 50 %.


  5. Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 [ Time Frame: 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.

    PASI90 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 90 %.


  6. Experience of a Rebound Effect Within 2 Months After Stopping Therapy [ Time Frame: Within 2 months of stopping therapy ]
    Rebound is defined as worsening of psoriasis over baseline value with more than 125 % or new pustular, erythrodermic or more inflammatory psoriasis within 2 months of stopping therapy.

  7. Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12 [ Time Frame: Week 12 ]

    Two methods were used for the evaluation of BSA:

    1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
    2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)

  8. Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12 [ Time Frame: Baseline up to Week 12 ]

    Two methods were used for the evaluation of BSA:

    1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
    2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.

  9. Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis [ Time Frame: During the 12-week Treatment Period ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245765


Locations
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France
Besancon, France
Creteil, France
Nice Cedex 3, France
Paris, France
Pierre Benite, France
Saint-Etienne, France
Germany
Berlin, Germany
Bonn, Germany
Essen, Germany
Frankfurt, Germany
Göttingen, Germany
Hamburg, Germany
Kiel, Germany
Mainz, Germany
Munster, Germany
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma

Additional Information:
Publications of Results:
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.
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.
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.
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.
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.
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.
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.
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.

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ClinicalTrials.gov Identifier: NCT00245765    
Other Study ID Numbers: C87040
2005-002141-39 ( EudraCT Number )
First Posted: October 28, 2005    Key Record Dates
Results First Posted: May 3, 2019
Last Update Posted: May 3, 2019
Last Verified: January 2019
Keywords provided by UCB Pharma:
chronic plaque psoriasis, anti TNFα
CDP870, Cimzia
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents