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Outcome of Treatment With Secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis at Tertiary Care Hospital.

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Secukinumab Injection
Sponsored by
Jinnah Postgraduate Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Plaque Psoriasis, Secukinumab Injection, Outcome

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Known plaque psoriasis Either gender Age 30-80 years. Exclusion Criteria: Patients with history of eczema. Patients with history connective tissue disorder, vasculitis malignancy, seropositive or seronegative arthritis. Patients with history of malignancy. Patient with history of hepatis B, C or AIDS. Immunocompromised patients. Pregnant patients assessed by history and confirmed by dating scan. Patients with history of chronic liver disease, chronic kidney disease, asthma, acute coronary syndrome, congestive heart failure and chronic obstructive pulmonary disease will be excluded.

Sites / Locations

  • Jinnah Post graduate Medical centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Secukinumab

Arm Description

Injection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months.

Outcomes

Primary Outcome Measures

Efficacy of Secukinumab in the treatment of moderate to severe plaque psoriasis
Efficacy will be assessed using psoriasis area and severity index. The minimum score of psoriasis area and severity index is 0 and the maximum score is 72. All patients who will be presented with 75% reduction in the Psoriasis Area and Severity Index at the end of the therapy compared to baseline will be labelled as positive for efficacy.

Secondary Outcome Measures

Mean difference of Psoriasis Area and Severity Index score before and after the treatment
Psoriasis area and severity index score difference before the treatment and after the treatment will be measured

Full Information

First Posted
March 22, 2023
Last Updated
June 4, 2023
Sponsor
Jinnah Postgraduate Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05891964
Brief Title
Outcome of Treatment With Secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis at Tertiary Care Hospital.
Official Title
Outcome of Treatment With Secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis at Tertiary Care Hospital.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
June 5, 2022 (Actual)
Study Completion Date
July 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinnah Postgraduate Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Psoriasis is one of the most common immune-mediated inflammatory disorders characterized by a chronic course. It affects approximately 2-3% of the world's population Psoriasis may be provoked by environmental factors in patients with genetic predispositions. Psoriasis is phenotypically characterized by thickened, red, scaly plaques and systemic inflammation, it is also associated with multiple comorbidities, such as cardiovascular disease, stroke, hypertension, metabolic diseases, chronic kidney disease, and joint destruction. Psoriasis is pathogenically driven by proinflammatory cytokines and mediated by T and dendritic cells. Inflammatory myeloid dendritic cells release interleukin (IL) 23 and IL-12 to activate IL-17-producing T cells, Th1 cells, and Th22 cells to produce psoriatic cytokines like IL-17, interferon (IFN) γ, TNF, and IL-22. These cytokines mediate the effects on keratinocytes. Secukinumab is a recombinant human monoclonal antibody that specifically binds to a proinflammatory cytokine released by T-helper-17 (Th17) cells, IL-17A. It blocks its binding with IL-17R and the expression of cytokines. This blockade normalizes the inflammatory processes and combats epidermal hyperproliferation, T-cell infiltration, and exaggerated expression of pathogenic genes.
Detailed Description
Plaque psoriasis is a chronic autoimmune skin disorder characterized by the formation of thick, scaly plaques on the skin surface. It affects millions of individuals worldwide and significantly impacts their quality of life. While several treatment options exist, a substantial number of patients with moderate to severe plaque psoriasis fail to achieve satisfactory results or experience intolerable side effects with conventional therapies. Psoriasis is pathogenically driven by proinflammatory cytokines and mediated by T cells and dendritic cells. In recent years, the advent of biologic agents targeting specific immune pathways has revolutionized the management of psoriasis. Secukinumab, a fully human monoclonal antibody that selectively inhibits interleukin-17A, has shown promising results in randomized controlled trials and real-world studies. However, there remains a need to assess the real-world effectiveness and safety of Secukinumab in routine clinical practice, particularly in patients with moderate to severe plaque psoriasis who may have diverse characteristics and treatment histories. This observational study aims to evaluate the real-world effectiveness and safety of Secukinumab in patients with moderate to severe plaque psoriasis. By collecting data from a diverse patient population in routine clinical settings, we aim to provide valuable insights into the outcomes and experiences of patients receiving Secukinumab outside the controlled environment of clinical trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Plaque Psoriasis, Secukinumab Injection, Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab
Arm Type
Experimental
Arm Description
Injection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months.
Intervention Type
Drug
Intervention Name(s)
Secukinumab Injection
Other Intervention Name(s)
Cosentyx
Intervention Description
Injection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months.
Primary Outcome Measure Information:
Title
Efficacy of Secukinumab in the treatment of moderate to severe plaque psoriasis
Description
Efficacy will be assessed using psoriasis area and severity index. The minimum score of psoriasis area and severity index is 0 and the maximum score is 72. All patients who will be presented with 75% reduction in the Psoriasis Area and Severity Index at the end of the therapy compared to baseline will be labelled as positive for efficacy.
Time Frame
From day of randomisation until final dose of drug,assessed upto 12 months.
Secondary Outcome Measure Information:
Title
Mean difference of Psoriasis Area and Severity Index score before and after the treatment
Description
Psoriasis area and severity index score difference before the treatment and after the treatment will be measured
Time Frame
From day of randomisation until final dose of drug,assessed upto 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Known plaque psoriasis Either gender Age 30-80 years. Exclusion Criteria: Patients with history of eczema. Patients with history connective tissue disorder, vasculitis malignancy, seropositive or seronegative arthritis. Patients with history of malignancy. Patient with history of hepatis B, C or AIDS. Immunocompromised patients. Pregnant patients assessed by history and confirmed by dating scan. Patients with history of chronic liver disease, chronic kidney disease, asthma, acute coronary syndrome, congestive heart failure and chronic obstructive pulmonary disease will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faiza I Siddiqui
Organizational Affiliation
Jinnah post graduate Medical centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rabia Ghafoor
Organizational Affiliation
Jinnah post graduate Medical centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Post graduate Medical centre
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75510
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Outcome of Treatment With Secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis at Tertiary Care Hospital.

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