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

NCT00936065 | Completed Phase 4 Results

• 2 other identifiers: 0881A6-4625B1801065
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Moderate to Severe Psoriasis

Keywords

Etanercept; Acitretin; Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24

  Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

  Week 24

Secondary Outcomes (32)

• Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score

  Weeks 2, 4, 8, 12, 18, and 24

• Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear

  Baseline, Weeks 2, 4, 8, 12, 18 and 24

• Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear

  Baseline, Weeks 2, 4, 8, 12, 18 and 24

• Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild

  Baseline, Weeks 2, 4, 8, 12, 18 and 24

• Time to Achieve a PASI 50 Score

  Baseline up to Week 24

Study Arms (3)

Group A

ACTIVE COMPARATOR

Drug: Etanercept

Group B

EXPERIMENTAL

Drug: Etanercept + Acitretin

Group C

ACTIVE COMPARATOR

Drug: Acitretin

Interventions

Etanercept DRUG

Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks

Also known as: Etanercept 50mg followed by 25mg

Group A

Etanercept + Acitretin DRUG

Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks

Also known as: Etancercept 25mg and Acitretin 10mg

Group B

Acitretin DRUG

Acitretin at a dose of 10mg BID for 24 weeks

Also known as: Acitretin 10mg

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

Pfizer Investigational Site

Daejeon, Korea, 301 721, South Korea

Location

Pfizer Investigational Site

Gyeonggido, Korea, 420 717, South Korea

Location

Pfizer Investigational Site

Seoul, Korea, 110 744, South Korea

Location

Pfizer Investigational Site

Seoul, Korea, 130 702, South Korea

Location

Pfizer Investigational Site

Seoul, Korea, 137 701, South Korea

Location

Pfizer Investigational Site

Seoul, Korea, 152 703, South Korea

Location

Pfizer Investigational Site

S0, Seoul, 137-701, South Korea

Location

Pfizer Investigational Site

Seoul, Seoul, 431-070, South Korea

Location

Pfizer Investigational Site

Seoul, 135 710, South Korea

Location

Pfizer Investigational Site

Seoul, 138 736, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27455955 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept; Acitretin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Limitations and Caveats

One of the protocol-defined endpoints was change from baseline in the participant's assessment of general health, however data was collected and analyzed for change from baseline in the participant's assessment of joint pain.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 9, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 9, 2012
• Results First Posted: April 9, 2012

Record last verified: 2012-03

Locations

KR (10)