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 |
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Recruitment Status :
Completed
First Posted : October 28, 2005
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Plaque Psoriasis | Drug: Certolizumab Pegol Other: Placebo | Phase 2 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Subcutaneous injections of Placebo every 2 weeks
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Other: Placebo
Matching Placebo to Certolizumab Pegol |
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Experimental: Certolizumab Pegol 200 mg
Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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Drug: Certolizumab Pegol
Other Name: Cimzia |
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Experimental: Certolizumab Pegol 400 mg
Subcutaneous injections of 400 mg every 2 weeks
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Drug: Certolizumab Pegol
Other Name: Cimzia |
- 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 %.
- 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)
- 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).
- 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).
- 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).
- 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 %.
- 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 %.
- 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.
- 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:
- 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
- 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 %)
- 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:
- 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
- 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.
- Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis [ Time Frame: During the 12-week Treatment Period ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| 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 | |
| Study Director: | UCB Clinical Trial Call Center | UCB Pharma |
| 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 |
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chronic plaque psoriasis, anti TNFα CDP870, Cimzia |
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Certolizumab Pegol Tumor Necrosis Factor Inhibitors |
Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |