Medical Information
Feltham, United Kingdom
NCT Number: NCT00249808
This is a Phase IIIb/IV, open label, multicentre study of efalizumab (anti cluster of differentiation [CD] 11a recombinant human monoclonal antibody) in participants with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, and psoralen and ultraviolet A phototherapy (PUVA).
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Feltham, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive efalizumab 1.0 milligram per kilogram (mg/kg) (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment [FT]). Depending on the response at Week 12, participants could receive additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
Time frame: Week 12
The PGA assesses the global response of all psoriatic lesions to therapy by comparing the participant's present condition to baseline. PGA response includes: Cleared (100 percent [%] improvement; remission of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Excellent (75% to 99% improvement of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Good (50% to 74% improvement of all clinical signs and symptoms); Fair (25% to 49% improvement of all clinical signs and symptoms); Slight (1% to 24% improvement of all clinical signs and symptoms); Unchanged (clinical signs and symptoms unchanged); Worse (clinical signs and symptoms deteriorated). Percentage of participants with PGA ratings of Good or Better (i.e, Good, Excellent or Cleared) are reported.
Time frame: Up to 8 weeks after end of FT (up to Week 20)
Rebound was defined as worsening of disease as assessed by Psoriasis Area and Severity Index (PASI) score >125% of baseline or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 2 months of stopping therapy. PASI is an instrument used to assess the extent of cutaneous psoriasis and to measure the effects of therapy. The PASI divides the body into four anatomical regions: head, trunk, upper limbs, and lower limbs. For each region, the evaluator assesses the severity of erythema, induration/thickness and scaling and determines the percentage of the region affected by disease. A numerical PASI score is derived that evaluates the severity of symptoms in terms of the total body surface area affected. Total PASI score ranges from 0 to 72, with higher scores indicating more severe disease.
Time frame: During study (40 weeks)
Exacerbation was defined as disease worsening either during or after treatment which was more inflammatory in nature compared to baseline and occurred either within pre-existing plaques, at previously uninvolved sites, or as new morphologies of disease.
Merck KGaA, Darmstadt, Germany
Industry
A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Efalizumab in the Treatment of Adult Patients With Moderate to Severe Chronic Plaque Psoriasis Who Have Failed to Respond to, or Who Have a Contraindication to, or Are Intolerant to Other Systemic Therapies Including Ciclosporin, Methotrexate and PUVA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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