An Observational Study To compare oral apremilast to oral methotrexate in psoriasis patients.
- Conditions
- Health Condition 1: L400- Psoriasis vulgaris
- Registration Number
- CTRI/2019/02/017579
- Lead Sponsor
- DR H ANCHTIHA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 and PASI 75 <br/ ><br>2)Changes in body surface area (BSA) <br/ ><br>3)Change from baseline in the disease activity scores in terms of PASITimepoint: 16 weeks after initiation of treatment
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>3)Rate of discontinuation of treatment <br/ ><br>4)Reasons for discontinuation <br/ ><br>Timepoint: 16 weeks