Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

NCT ID: NCT06043752

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2023-08-05

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Remsima

Group Type: EXPERIMENTAL

Remsima

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ghurki Trust and Teaching Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Dr. Haroon Nabi

Role: STUDY_DIRECTOR

Professor Department of Dermatology LMDC

Dr. Nabigha Khalid

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology Ghurki Hospital

Dr. Saleha Batool

Role: STUDY_CHAIR

Assistant Professor Department of Dermatology, SIMS Hospital

Dr. Sumera Hanif

Role: STUDY_CHAIR

Senior Registrar Dermatology Department

Dr. Talat Masood Akbar

Role: STUDY_CHAIR

Associate Professor Dermatology LMDC GTTH

Dr. Faria Asad

Role: STUDY_CHAIR

Professor/ Head of Dermatology Department

Locations

Ghurki Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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

Reference Type: BACKGROUND

PMID: 23974692 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11410193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28498543 (View on PubMed)

Other Identifiers

D7

Identifier Type: -

Identifier Source: org_study_id