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Clinical Trial Name - Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswi
| Original Study ID : 0881A1-101781 |
| NCT ID : NCT00581165 |
| Brief Title : Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept |
| Official Title : Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept |
| 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. |
| Source : Wyeth |
| Overall Status : Completed |
| Start Date : February 2006 |
| End Date : August 2007 |
| Completion Date : August 2007 |
| Official Title : Phase 4 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Open Label, Single Group Assignment, Safety Study |
| Enrollment : 500 |
| Verification Date : December 2007 |
| First Received Date : December 21, 2007 |
| Trial Eligibility |
| Criteria : 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 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| OutComes |
| Primary OutComes |
| Measure : Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment |
| Time Frame : 18 months |
| Safety issue : Yes |
| Secondary OutComes |
| Measure : 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 |
| Time Frame : 18 months |
| Safety issue : Yes |
| Interventions |
| Type : Drug |
| Name : Etanercept |
| Description : recommended dose of enbrel is 25mg administered twice weekly. |
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