You are here

Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Daejeon, Korea, 301 721 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Moderate to Severe Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Active, moderate to severe psoriasis defined by the following criteria: Clinically
stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.

- In the opinion of the investigator, failure, intolerance, contraindication or not a
candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus
ultraviolet A radiation (PUVA) therapy.

- Negative urine pregnancy test before the first dose of study drug in all female
patients

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere
with evaluations of the effect of study medication on psoriasis.

- Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout,
systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or
associated syndromes.

- Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab
(Raptiva®) and alefacept (Amevive®) is also prohibited.

NCT00936065
Pfizer
Completed
Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Oligodendroglioma, Astrocytoma, Malignant Glioma
NCT02764151
All Genders
18+
Years
Multiple Sites
Hepatocellular Carcinoma
NCT03289533
All Genders
20+
Years
Multiple Sites
Systemic Lupus Erythematosus, Rheumatoid Arthritis
NCT03334851
All Genders
18+
Years
Multiple Sites
Androgen Receptor Positive Triple Negative Breast Cancer Advanced
NCT01889238
Females
18+
Years
Multiple Sites
Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis
A Multicenter, Randomized, Open Pilot Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly Followed Etanercept 25mg Twice Weekly, the Combination of Etanercept 25 mg Twice Weekly and Acitretin and Acitretin Alone in Patients With Moderate to Severe Psoriasis
To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Moderate to Severe Psoriasis
  • Drug: Etanercept
    Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks
    Other Name: Etanercept 50mg followed by 25mg
  • Drug: Etanercept + Acitretin
    Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks
    Other Name: Etancercept 25mg and Acitretin 10mg
  • Drug: Acitretin
    Acitretin at a dose of 10mg BID for 24 weeks
    Other Name: Acitretin 10mg
  • Active Comparator: Group A
    Intervention: Drug: Etanercept
  • Experimental: Group B
    Intervention: Drug: Etanercept + Acitretin
  • Active Comparator: Group C
    Intervention: Drug: Acitretin
Lee JH, Youn JI, Kim TY, Choi JH, Park CJ, Choe YB, Song HJ, Kim NI, Kim KJ, Lee JH, Yoo HJ. A multicenter, randomized, open-label pilot trial assessing the efficacy and safety of etanercept 50 mg twice weekly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone in patients with moderate to severe psoriasis. BMC Dermatol. 2016 Jul 25;16(1):11. doi: 10.1186/s12895-016-0048-z.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.
  • In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy.
  • Negative urine pregnancy test before the first dose of study drug in all female patients

Exclusion Criteria:

  • Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  • Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
  • Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00936065
0881A6-4625
B1801065
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now