Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: Etanercept |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis |
- Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
- Dermatology Live Quality Index (DLQI) response at week 12
- Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
- Psoriasis pain (VAS) at week 12
- Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
- PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
- Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
- Adverse events, infections injection site reactions during long-term therapy
- Serious adverse events and infections during long-term therapy
- Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2003 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00111449 History of Changes |
| Other Study ID Numbers: | 20030117 |
| Study First Received: | May 20, 2005 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Psoriasis, adults skin, Phase 3 clinical trial, Amgen etanercept, Enbrel® moderate, severe |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013