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OpenTrials
Completed

NCT Number: NCT06043752

Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ghurki Hospital

Lahore, Punjab Province, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remsima

Drug

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ghurki Trust and Teaching Hospital

Other

Registry information

Official study title

Efficacy and Safety of Infliximab Biosimilar Remsima in Treatment of Chronic Plaque Psoriasis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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