Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis

Study Overview
=================
Brief Summary
-----------------
In this study the investigators intend to compare the efficacy and safety of two fixed doses of once weekly oral methotrexate in a prospective randomized double blind manner in patients with severe plaque type psoriasis.

Official Title
-----------------
Efficacy and Safety of Methotrexate in 2 Fixed Doses of 10mg or 25mg Orally Once Weekly in Patients With Severe Plaque Type Psoriasis: a Prospective, Randomized, Double Blind, Dose Ranging Study

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with plaque-type psoriasis having more than 10% body surface area involvement (severe psoriasis).20 Patients of either sex with age between 18-65 years. Females who were postmenopausal or tubectomised or have completed their family size and are willing to maintain contraception 1 month before, during and 1 month after completion/stopping of treatment and negative pregnancy test 2 weeks before starting of treatment and at day 2 or 3 of a normal menstrual cycle. Males who were willing to maintain contraception during and 3 months after completion/stopping of treatment. Exclusion Criteria: Pregnant or lactating women. Any abnormalities in renal function, cardiovascular disease, respiratory disease or neuropsychiatric illness. Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP >1.5 times the upper limit of normal), viral hepatitis or cirrhosis. history of excessive alcohol consumption. Severe anemia, leucopenia or thrombocytopenia. Active infectious disease or immune system deficiency including AIDS. history of intolerance/hypersensitivity to methotrexate. history of phototherapy in past 6 months. Patients who had received any systemic treatment for psoriasis in the past 4 weeks and topical treatment in the past 2 weeks. Body mass index (BMI) > 30 kg/m2.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: methotrexate 10 mg<br>oral methotrexate 10 mg once weekly | Drug: Methotrexate<br>* once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75<br>|
| Active Comparator: methotrexate 25mg<br>oral methotrexate 25 mg once weekly | Drug: Methotrexate<br>* once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Psoriasis Area and Severity Index (PASI) score between two groups from baseline to 12 weeks |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to achieve PASI 75 |  | 12 weeks or earlier | 
| number of patients achieving PASI 90 and 100 |  | 12 weeks or earlier |