Plaque psoriasis MedDRA version: 14.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Enbrel 25mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Num
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eighteen (18) years of age or older at time of consent. 2. Previously treated with ETN for chronic plaque PSO for at least 12 weeks prior to the screening visit, and received a total weekly dose of 50 mg per week for at least the 6 weeks preceding the day of the screening visit. 3. Having shown clinical response with a PGA = 1 at the screening visit. 4. With a PGA = 1 at the baseline visit. 5. Where the last injection of ETN was performed not more than 7 days before the baseline visit. 6. Able to store the injectable investigational product under refrigerated conditions. 7. Able to self-inject investigational product or have a designee who can do so. 8. Able to complete health outcome assessments and any study diaries. 9. Demonstrates an adequate screening for tuberculosis (TB) prior to initiation of therapy with ETN, in accordance with local country guidelines Since ETN has been prescribed prior to the enrollment in the study, tests results and/or radiographic report must be available at site. 10. Is a man or woman who is surgically sterile or is at least 1 year postmenopausal. A woman not surgically sterile or at least 1 year postmenopausal must demonstrate a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline, and must agree and commit to use medically acceptable forms of contraception. All female subjects who are also taking known teratogens, eg methotrexate, acitretin, must agree and commit to use contraceptive precautions as recommended by the respective SPCs, data sheets or equivalent legal documents. In addition, all male subjects taking concomitant methotrexate who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of methotrexate Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: 1. Evidence of skin conditions (eg, eczema) other than PSO that would interfere with evaluations of the effect of study medication on PSO. 2. Evidence of active or previously known medical history of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis). 3. Any biologics other than ETN within the 20 weeks prior to the screening visit. 4. Cyclosporin, within 28 days of the baseline visit. 5. Receipt of any live (attenuated) vaccine within 4 weeks before baseline. 6. Sunbathing or UV treatment for therapeutic reasons (ultraviolet light A [UVA], psoralen and ultraviolet light A therapy [PUVA], or ultraviolet light B [UVB] therapy, including narrow band UVB and excimer laser) within 28 days of the baseline visit. 7. Oral, intravenous, intramuscular, intra-articular, and subcutaneous (SC) corticosteroids within 28 days of the baseline visit. Exception: inhaled corticosteroids for the treatment of pulmonary conditions and topical ophthalmic solutions containing corticosteroids with or without antibiotics for episodes of acute ocular inflammation are permitted. 8. Abnormal hematology or blood chemistry profile at screening: - hemoglobin =85 g/L; - hematocrit =27%; - platelet count =125 x 10 to the power of 9/L; - white blood cell count =3.5 x 10 to the power of 9/L; - serum creatinine (Creat) =175 µmol/L; - aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level =2 times the laboratory’s upper limit of normal (ULN). Exclusionary screening laboratory tests that are considered, in the opinion of the investigator, to be due to an error or a transient condition, may be repeated once during the screening period for confirmation. 9. Clinically relevant concurrent medical events including: - Serious infection (infection associated with hospitalization and/or intravenous antibiotics) within 1 month before investigational product administration or active infection at screening, including known human immunodeficiency virus (HIV) infection. - Current or recent (within 2 years of screening) active TB infection (Note: local country guidelines should be followed for appropriate TB screening and prophylaxis in the setting of anti-TNF therapy, including a minimum of a chest radiograph and/or objective TB testing, such as purified protein derivative [PPD] or Quantiferon depending on what is acceptable per local guidelines). - Untreated latent TB. Subjects with latent TB infection may be allowed only if local guidelines are followed for prophylactic therapy and if treatment is initiated before therapy, followed by proof that no adverse drug reaction has occurred with the anti-TB medications. - Uncontrolled hypertension (defined as screening systolic blood pressure >160 mm Hg or screening diastolic blood pressure >100 mm Hg). Exclusionary blood pressure measurements that are considered, in the opinion of the investigator, to be due to an error or a transient condition, may be repeated once during the screening period for confirmation. - Myocardial infarction within 12 months of the screening visit. - Unstable angina pe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the effect on subjects in whom psoriasis has responded to initial treatment with etanercept (ETN) of two different strategies for managing a good response or complete response (PGA= 1 or 0) over a 52 week period..;Primary end point(s): The primary efficacy endpoint is the average 52 week PGA (measured as the time-normalized area under curve) ;Timepoint(s) of evaluation of this end point: Describe the effect on subjects in whom Psoriasis has responded with Good response or Complete response (PGA = 1or 0) over a 52-week time period; Secondary Objective: • To compare the efficacy of the 2 different strategies by reference to quality of life measure over the duration of the study • To explore the time course of severity following treatment modification • To explore the degree of subject satisfaction with the two different options for management following successful initial treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: 1. Time-normalized area under the DLQI vs time curve. 2. Patient satisfaction with PSO treatment at baseline, before retreatment with ETN 50 mg weekly, and at the end of retreatment. 3. Mean PGA at week 52. Other secondary exploratory endpoints: 1. Proportion of time that subjects achieve a PGA of 0 or 1. 2. Time to a first retreatment with ETN 50 mg, starting from randomization. 3. Proportion of subjects who achieve PGA of 0 or 1. 4. Time to achieve a PGA of 0 or 1, starting from the time of dose escalation. 5. Change from baseline in the PGA at the each visit during the 52 weeks. 6. Change from baseline in the PASI at the each visit during the 52 weeks. 7. Patient acceptability of current PSO symptoms at baseline before restarting ETN 50 mg weekly until decreasing the dose again as per the randomization. 8. EQ-5D. 9. SGA 10. Change in scores on WPAI: PSO. 11. Change in data captured on the Subject Pharmacoeconomic Questionnaire ; Timepoint(s) of evaluation of this end point: 1. Compare the efficacy of the 2 different strategies by reference to quality of life (QoL) measure over the duration of the study. 2. To explore the time course of severity following treatment modification. 3. To explore the degree of subject satisfaction with the 2 different options for management following successful initial treatment. | — |
Countries
France, Germany, Greece, Hungary, Italy, Portugal, Spain, Turkey, United Arab Emirates, United Kingdom
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc.
Outcome results
None listed