Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00245765
Other study ID # C87040
Secondary ID 2005-002141-39
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2005
Est. completion date November 2006

Study information

Verified date January 2019
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Certolizumab Pegol
Pharmaceutical Form: solution for injection in pre-filled syringe Route of Administration: subcutaneous use
Other:
Placebo
Matching Placebo to Certolizumab Pegol

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
UCB Pharma

Countries where clinical trial is conducted

France,  Germany, 

References & Publications (9)

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

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.Aca

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 D

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.Vene

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-contr

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

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-treatm — View Citation

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,

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 Europ

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Time to Psoriasis Activity and Severity Index 50 (PASI50) 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).
During the 12-weeks Treatment Period
Secondary Time to Psoriasis Activity and Severity Index 75 (PASI75) 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).
During the 12-weeks Treatment Period
Secondary Time to Relapse 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). During the 12-weeks Treatment Period
Secondary Achievement of a Psoriasis Activity and Severity Index (PASI50) 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.
PASI50 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 50 %.
Week 12
Secondary Achievement of a Psoriasis Activity and Severity Index (PASI90) 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.
PASI90 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 90 %.
Week 12
Secondary Experience of a Rebound Effect Within 2 Months After 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. Within 2 months of stopping therapy
Secondary Percent of Body Surface Area (BSA) Affected by Psoriasis at 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 %)
Week 12
Secondary Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at 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.
Baseline up to Week 12
Secondary Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis During the 12-week Treatment Period
See also
  Status Clinical Trial Phase
Completed NCT03598790 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3
Completed NCT00799877 - Chronic Plaque Psoriasis (Ps) Registry
Completed NCT02581345 - Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis Phase 3
Withdrawn NCT01200264 - Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy Phase 2
Terminated NCT00972543 - Raptiva in Palm and Sole Psoriasis Phase 4
Not yet recruiting NCT00707070 - Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis Phase 4
Completed NCT00539929 - Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis Phase 2
Completed NCT02852967 - A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis Phase 2
Completed NCT00770965 - Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis Phase 2
Active, not recruiting NCT06011733 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT00673556 - A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate Phase 3
Terminated NCT00844363 - Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris N/A
Completed NCT00574249 - Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment Phase 3
Completed NCT00512187 - Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial Phase 4
Completed NCT02570750 - The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Completed NCT00438360 - Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis Phase 3
Active, not recruiting NCT03897075 - Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis Phase 3
Completed NCT01358578 - Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis Phase 3
Completed NCT03536884 - A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3
Completed NCT03230292 - A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis Phase 2