Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Remsima
Sponsored by

About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Ghurki Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remsima
Arm Description
Outcomes
Primary Outcome Measures
Psoriasis Area Severity Index Score
Patients will be followed 4,8,14 and 24 weeks
Adverse Events
Patients will be followed 4,8,14 and 24 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT06043752
First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
Ghurki Trust and Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06043752
Brief Title
Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis
Official Title
Efficacy and Safety of Infliximab Biosimilar Remsima in Treatment of Chronic Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
August 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ghurki Trust and Teaching Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remsima
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Remsima
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psoriasis Area Severity Index Score
Description
Patients will be followed 4,8,14 and 24 weeks
Time Frame
24 weeks
Title
Adverse Events
Description
Patients will be followed 4,8,14 and 24 weeks
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Haroon Nabi
Organizational Affiliation
Professor Department of Dermatology LMDC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dr. Nabigha Khalid
Organizational Affiliation
Department of Dermatology Ghurki Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Saleha Batool
Organizational Affiliation
Assistant Professor Department of Dermatology, SIMS Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. Sumera Hanif
Organizational Affiliation
Senior Registrar Dermatology Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. Talat Masood Akbar
Organizational Affiliation
Associate Professor Dermatology LMDC GTTH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. Faria Asad
Organizational Affiliation
Professor/ Head of Dermatology Department
Official's Role
Study Chair
Facility Information:
Facility Name
Ghurki Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23974692
Citation
Arsiwala S. Infliximab: efficacy in psoriasis. Indian J Dermatol Venereol Leprol. 2013 Jul;79 Suppl 7:S25-34. doi: 10.4103/0378-6323.115525.
Results Reference
background
PubMed Identifier
11410193
Citation
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.
Results Reference
background
PubMed Identifier
28498543
Citation
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.
Results Reference
background
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Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis
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