A Study of Efalizumab in Participants With Moderate to Severe Chronic Psoriasis Who Have Failed, Have a Contraindication to, or Are Intolerant of Other Systemic Therapies
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|ClinicalTrials.gov Identifier: NCT00249808|
Recruitment Status : Completed
First Posted : November 7, 2005
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Efalizumab - anti-CD11a recombinant human monoclonal antibody||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1266 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 13, 2004|
|Actual Primary Completion Date :||January 25, 2007|
|Actual Study Completion Date :||January 25, 2007|
Drug: Efalizumab - anti-CD11a recombinant human monoclonal antibody
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.
- Percentage of Participants With Physician's Global Assessment (PGA) Ratings of Good or Better (FT) [ 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.
- Percentage of Participants With Psoriasis Rebound [ 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.
- Percentage of Participants With Psoriasis Exacerbation [ 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.
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): NCT00249808
|Feltham, United Kingdom|
|Study Director:||Medical Responsible||Merck KGaA, Darmstadt, Germany|