Not Signed In -
Methotrexate Injection |
Amethopterin; MTX Injection |
Clinical Trial: Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis
This study is currently recruiting patients.
Verified by Wyeth September 2005
|
Purpose
The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.
| Condition | Intervention |
|---|---|
| Plaque psoriasis | Drug: Etanercept Drug: Methotrexate |
MedlinePlus related topics: Psoriasis
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Open-Label, Randomized, Pilot-Study to Evalute the Efficacy and Safety of the Combination of Etanercept (ETN) and Methotrexate and of Etanercept (ETN) Alone in Patients with Plaque Psoriasis Despite Methotrexate Therapy.
Further Study Details:
Primary Outcomes: Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.
Secondary Outcomes: Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75; and 90. Time to clear or almost clear on PGA.
Expected Total Enrollment: 60
Secondary Outcomes: Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75; and 90. Time to clear or almost clear on PGA.
Expected Total Enrollment: 60
Study start: April 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Active plaque psoriasis involving >10% body surface area and/or minimal screening PASI score 8.
- Methotrexate >7.5 mg/week for the last 3 months
Exclusion Criteria:
- Predominantly guttate, erythrodermic or pustular psoriasis
- Other skin conditions than psoriasis
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00161655
Trial Manager MedInfoNord@wyeth.com
Denmark, Copenhagen
Fredriksberg Alle, Copenhagen, Denmark; Recruiting
see Central Contact
Denmark, Hellerup
Gentofte Amtsygehus, Hellerup, Denmark; Recruiting
see Central Contact
Finland
Helsinki, Finland; Recruiting
see Central Contact
Tampere, Finland; Recruiting
see Central Contact
Norway, Olso
Rikshospitalet, Olso, Norway; Recruiting
see Central Contact
Norway, Tromsö
Hudlegekontoret Akutten, Tromsö, Norway; Recruiting
see Central Contact
Sweden, Farsta
Läkarhuset Fasta Centrum, Farsta, Sweden; Recruiting
see Central Contact
Sweden, Vällingby
Läkarhuset, Vällingby, Sweden; Recruiting
see Central Contact
Study chairs or principal investigators
Medical Monitor, Study Director, Wyeth Research
Trial Manager, Principal Investigator, For Finland, clinicaltrialinfo@wyeth.com
More Information
Study ID Numbers: 0881A-101696
Last Updated: September 11, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00161655
Health Authority: Denmark: Danish Medicines Agency; Norway: Norwegian Medicines Agency; Sweden: Swedish National Council on Medical Ethics; Finland: Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 11, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00161655
Health Authority: Denmark: Danish Medicines Agency; Norway: Norwegian Medicines Agency; Sweden: Swedish National Council on Medical Ethics; Finland: Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13
email this page
print this page
bookmark this page
feedback on this page
