NCT06043752

Brief Summary

Psoriasis is a persistent condition which demands prolonged management, so it puts heavy financial as well as psychological burden on patients. Severe psoriasis makes work impossible for patients. If it affects exposed parts of the body, it may lead to decrease in self-esteem, social avoidance, and shame. Patients with even mild form of psoriasis have high stigma as compared to other cutaneous diseases. As a result, psoriasis affected individuals experience greater difficulty in social interactions and employment. Patients experience symptoms in psoriasis includes bleeding, itching and inflamed joints. Psoriatic patients develop psoriatic arthritis approximately at 40 years of age which contributes to fatigue in these individuals. Moreover, early age onset of psoriasis leads to more physical impairment. Hence, patients get trapped in a vicious cycle as stress leads to further aggravation of disease. The European Medicine Agency has given its approval regarding the usage of INFLIXIMAB bio similar REMSIMA for psoriasis after taking in consideration its effectiveness from other studies conducted on ankylosing spondylitis and rheumatoid arthritis. This study is being conducted as no data is present on REMSIMA SC in psoriasis patient in Pakistan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

September 12, 2023

Last Update Submit

September 12, 2023

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Psoriasis Area Severity Index Score

    Patients will be followed 4,8,14 and 24 weeks

    24 weeks

  • Adverse Events

    Patients will be followed 4,8,14 and 24 weeks

    24 weeks

Study Arms (1)

Remsima

EXPERIMENTAL
Drug: Remsima

Interventions

RemsimaDRUG

The patient will be given one Injection of REMSIMA 120 mg subcutaneously at week 0, 1, 2, 3, 4 and then every 2 weeks i.e., at 6, 8, 10 and 14 weeks. If the weight of the patient is \>80 kg, 2 injections will be given.

Remsima

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-59 years
  • Both genders
  • Diagnosed patient of Psoriasis
  • Moderate to severe psoriasis
  • Not responding to topical treatment
  • Not responding to conventional systemic treatments i.e., methotrexate, cyclosporine and phototherapy.
  • PASI score \>10.

You may not qualify if:

  • Patient with active systemic lupus erythematosus or ANA positive patients.
  • Patient with active tuberculosis.
  • Extremely immunocompromised patient.
  • Patient with cardiac disease.
  • Patient with allergic reaction to REMSIMA.
  • Pregnancy and Lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki Hospital

Lahore, Punjab Province, Pakistan

Location

Related Publications (3)

  • Arsiwala S. Infliximab: efficacy in psoriasis. Indian J Dermatol Venereol Leprol. 2013 Jul;79 Suppl 7:S25-34. doi: 10.4103/0378-6323.115525.

    PMID: 23974692BACKGROUND

  • Chaudhari U, Romano P, Mulcahy LD, Dooley LT, Baker DG, Gottlieb AB. Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial. Lancet. 2001 Jun 9;357(9271):1842-7. doi: 10.1016/s0140-6736(00)04954-0.

    PMID: 11410193BACKGROUND

  • Gisondi P, Bianchi L, Conti A, Dapavo P, Malagoli P, Piaserico S, Savoia F, Prignano F, Girolomoni G. Infliximab biosimilar CT-P13 in the treatment of chronic plaque psoriasis: data from the Psobiosimilars registry. Br J Dermatol. 2017 Dec;177(6):e325-e326. doi: 10.1111/bjd.15659. Epub 2017 Nov 22. No abstract available.

    PMID: 28498543BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

CT-P13

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Prof. Dr. Haroon Nabi

    Professor Department of Dermatology LMDC

    STUDY DIRECTOR

  • Dr. Nabigha Khalid

    Department of Dermatology Ghurki Hospital

    PRINCIPAL INVESTIGATOR

  • Dr. Saleha Batool

    Assistant Professor Department of Dermatology, SIMS Hospital

    STUDY CHAIR

  • Dr. Sumera Hanif

    Senior Registrar Dermatology Department

    STUDY CHAIR

  • Dr. Talat Masood Akbar

    Associate Professor Dermatology LMDC GTTH

    STUDY CHAIR

  • Dr. Faria Asad

    Professor/ Head of Dermatology Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

March 10, 2022

Primary Completion

July 15, 2023

Study Completion

August 5, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)