Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Control Intervention1: Oral Methotrexate: Oral Methotrexate 5mg-15mg/week
Control Intervention2: Oral Apremilast 30mg (BD): Oral Apremilast 30mg administered 1 tablet twice daily for 16 weeks
Sponsors
DR H ANCHTIHA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of moderate to severe plaque psoriasis defined by BSA > 10 or PASI > 10 or DLQI >10 2. Patients who are candidates for systemic therapy for psoriasis 3. Inadequate response to a previous systemic treatment 4. In good health as judged based on medical history, physical examination, serum chemistry labs, haematology values, and urinalysis. 5. Subjects are competent to sign and give informed consent 6. Subjects who willing to adhere to the Protocol and visit schedule.
Exclusion criteria
Exclusion criteria: 1.Patients with non-plaque forms of psoriasis (erythrodermic, guttate, pustular) 2.Pregnant or lactating women 3.Patients who had received any systemic treatment for psoriasis within 4 weeks of the baseline visit and topical treatment within the past 2 weeks of the baseline visit . 4.Phototherapy ultraviolet A with psoralen [PUVA] within 4 weeks of the baseline visit and/or ultraviolet B (UVB) within 2 weeks of the baseline visit 5.History of serious hypersensitivity to phosphodiesterase type 4 (PDE-4) inhibitors 6.Subjects with history of suicidal thought or other clinically significant psychiatric diseases 7.History of k/c/o congenital or acquired immunodeficiencies -HIV,Malignancy,Hepatitis B or C and other severe infection 8.Subject history of active tuberculosis infection or incompletely treated active or latent tuberculosis infection 9.Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 and PASI 75 2)Changes in body surface area (BSA) 3)Change from baseline in the disease activity scores in terms of PASITimepoint: 16 weeks after initiation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Changes in static physician global assessment (sPGA)Timepoint: At baseline and at 16weeks;2)Proportion of patients with Dermatology Life Quality Index (DLQI) â?¤5 3)Rate of discontinuation of treatment 4)Reasons for discontinuation Timepoint: 16 weeks | — |
Countries
India
Contacts
Public ContactDr H Anchitha
Kasturba medical college ,Mangalore
Outcome results
None listed