A comparison of efficacy and safety of oral tofacitinib vs methotrexate in management of moderate to severe chronic plaque psoriasis
- Conditions
- Health Condition 1: L400- Psoriasis vulgarisHealth Condition 2: L400- Psoriasis vulgaris
- Registration Number
- CTRI/2023/06/053443
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of either sex and age 18-70 years.
2.PASI >12 or BSA >10%
1.Age less than 18 or more than 70 years
2.Individuals with severe anaemia, leukopenia(lymphocytes <500 cells/mm3, ANC <500 cells/MM3,Hemoglobin <9g/dl), pre-existing liver diseases, bone marrow pathologies causing cytopenia,
3.Individuals with heavy alcohol consumption ( >14 units/week) or heavy smokers.
4.Individuals on concomitant medications such as high dose vitamin D, oral/topical steroids, PUVA, Acitretin, Dapsone, Sulfamethoxazole, Trimethoprim
5.Pregnant and lactating women
6.Patient having pre-existing uncontrolled Diabetes mallitus , Hypertension
7.Patients who have taken any immunosuppressant drugs, homeopathic/herbal medications in last 4 weeks.
8.Patients with malignancies/ history of malignancy.
9.Patients with risk/history of thromboembolism, cardiovascular accidents.
10.Patients with active infection, active/latent tuberculosis.
11.Patients found to have abnormal laboratory parameters that would increase the risk of adverse effect
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method improvement in PASI by 75% from baseline at 12 weekTimepoint: improvement in PASI by 75% from baseline at 12 week
- Secondary Outcome Measures
Name Time Method Improvement in PASI by 100% from baseline <br/ ><br>Physicians global assessment <br/ ><br>Dermatological Quality of life Index <br/ ><br>Safety analysisTimepoint: At 24 week