Study to Evaluate the Efficacy of Enbrel as a Biological Treatment in Moderate to Severe Plaque Psoriasis Patients

NCT04398732 | Completed Results

• 1 other identifier: B1801412
• Study Type: observational
• Target: 486
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate available local data in Iraqi patients with moderate to severe psoriasis on Enbrel treatment with regards to efficacy, treatment regimen adherence and patient characterization (i.e. age, gender, smoking status) using data from the Dermatologists in Baghdad Teaching Hospital registry

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Percent Body Surface Area (BSA) at Month 12

  Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis.

  Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

• Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12

  DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

  Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

• Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12

  The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis.

  Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

Secondary Outcomes (3)

• Percent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment

  Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

• Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment

  Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

• Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment

  Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)

Other Outcomes (3)

• Change From Baseline in Percent Body Surface Area (BSA) at Month 4

  Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)

• Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4

  Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)

• Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4

  Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)

Study Arms (1)

Patients with moderate to severe plaque psoriasis

Iraqi patients diagnosed with moderate to severe plaque psoriasis that received Enbrel as treatment for disease.

Drug: Enbrel

Interventions

Enbrel DRUG

As provided in real world practice

Patients with moderate to severe plaque psoriasis

Eligibility Criteria

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

Study Population

Patients data from the local registry at the Dermatology Center of Baghdad Teaching Hospital registry.

You may qualify if:

• Confirmed diagnosis of moderate to severe plaque psoriasis receiving etanercept treatment for a minimum duration of 1 year.
• Age ≥18 years old.
• No history of using a biological treatment, other than etanercept, for treatment of moderate to severe plaque psoriasis or any other reason.

You may not qualify if:

• Etanercept use for treatment moderate to severe plaque psoriasis less than 1 year duration.
• Previous use of other biological treatments for any reason

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Baghdad, Iraq

Location

Related Links

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

MeSH Terms

Interventions

Etanercept

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

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: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 21, 2020
• Study Start: July 5, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 1, 2021
• Results First Posted: November 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)