The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06043752
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Ghurki Trust and Teaching Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Remsima Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Infliximab Biosimilar Remsima in Treatment of Chronic Plaque Psoriasis
Actual Study Start Date : March 10, 2022
Actual Primary Completion Date : July 15, 2023
Actual Study Completion Date : August 5, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Remsima Drug: Remsima
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Psoriasis Area Severity Index Score [ Time Frame: 24 weeks ]
    Patients will be followed 4,8,14 and 24 weeks

  2. Adverse Events [ Time Frame: 24 weeks ]
    Patients will be followed 4,8,14 and 24 weeks


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043752


Locations
Layout table for location information
Pakistan
Ghurki Hospital
Lahore, Punjab, Pakistan
Sponsors and Collaborators
Ghurki Trust and Teaching Hospital
Investigators
Layout table for investigator information
Study Director: Prof. Dr. Haroon Nabi Professor Department of Dermatology LMDC
Principal Investigator: Dr. Nabigha Khalid Department of Dermatology Ghurki Hospital
Study Chair: 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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Ghurki Trust and Teaching Hospital
ClinicalTrials.gov Identifier: NCT06043752    
Other Study ID Numbers: D7
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases