Inflammation, Psoriasis
Conditions
Keywords
Clinical Trials
Brief summary
The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004. Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.
Interventions
DRUGetanercept
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Amgen
Study design
Allocation
NON_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
- Subjects who completed study 20030115 or 20030117 qualify to enroll into this study (provided that they meet all inclusion/
Exclusion criteria
). - Heterosexually active men and women of child-bearing potential must agree to use a medically acceptable form of contraception throughout the study. - Subject or designee must have the ability to self-inject investigational product. - Subject must be capable of understanding and giving written voluntary informed consent. - Negative serum pregnancy test less than or equal to 14 days prior to the first dose of investigational product in all female subjects (except those surgically sterile or at least 5 years postmenopausal)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Longitudinal changes from baseline for the Physician and Patient Global Assessments and DLQI | — |
Outcome results
None listed