Psoriasis
Conditions
Brief summary
Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain; (ii) the incidence of adverse events reported in these patients, and (iii) the role that age and concomitant therapy might play in the development of adverse reactions.
Interventions
DRUGEtanercept
recommended dose of enbrel is 25mg administered twice weekly.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent signed by patients prior to study entry 2. 18 years of age or older at screening visit 3. Patients with moderate to severe psoriasis 4. Patients who have failed conventional systemic treatment 5. Patients who have a contraindication to conventional systemic therapy 6. Patients who are intolerant to conventional systemic therapy 7. A negative serum pregnancy test at screening in women of childbearing potential 8. Able to self-inject study drug or have a designee who can do so 9. In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Reduction and/or withdrawal of systemic therapies, Proportion of patients with plaque psoriasis achieving PASI 50, 75 and 90 at each evaluation and BSA at each evaluation | 18 months |
Outcome results
None listed