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The goal of this clinical trial is to learn if Infliximab Biosimilar Remsima works to treat moderate to severe plaque Psoriasis in adults. It will also learn about the safety of the drug. The main questions it aims to answer are:
Does Infliximab-dyyb Biosimilar (Remsima) works to treat moderate to severe plaque Psoriasis in adults in reducing disease severity and relapses? What medical problems do participants have when taking Remsima?
Participants will:
be injected Infliximab Biosimilar Remsima weekly for 4 weeks and then fortnightly till 24 weeks They will be followed for efficacy and safety and lab tests at week 4, 14, 24 and 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Patients of moderate to severe plaque psoriasis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab-dyyb Biosimilar (Remsima) | Biological | Subcutaneous injections of Infliximab-dyyb Biosimilar (Remsima) were injected weekly for 4 weeks and then fortnightly for 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| At least 50% reduction in PASI | PASI should reduce to at least 50% of baseline (pre-treatment) | 14 weeks |
| At least 50% reduction in DLQI | DLQI (Dermatology Life Quality Index) should reduce to at least 50% of baseline (pre-treatment) | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of At least 50% reduction in PASI and DLQI | Maintenance of At least 50% reduction in PASI and DLQI from baseline (pre-treatment) | 24 weeks |
| Maintenance of At least 50% reduction in PASI and DLQI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Hira Tariq, MBBS, FCPS Derma | Services Institute of Medical Sciences, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Services Institute of Medical Sciences/ Services Hospital | Lahore | Punjab Province | 54000 | Pakistan |
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| Label | URL |
|---|---|
| Related Info | View source |
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Maintenance of At least 50% reduction in PASI and DLQI from baseline (pre-treatment)
| 52 weeks |
| ID | Term |
|---|---|
| C000591237 | CT-P13 |
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