Study to compare effectiveness of methotrexate-pioglitazone combination against methotrexate alone in patients of psoriasis, a skin disorder

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

1. Patients between 18 -65 years of age (both inclusive) with clinical diagnosis of plaque psoriasis as determined through clinical examination.

2. Patient should be a candidate for systemic therapy

3. PASI (Psoriasis Area and Severity Index) score of >= 12 at the Baseline visit.

4. 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.

5. Sexually active male subjects are able to participate in the study if they use effective contraception during the study and 3 months after study completion.

6. Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, and 12-lead electrocardiogram (ECG) performed at Screening.

7. Able and willing to give written informed consent and to comply with the requirements of this study protocol.

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.

•History of active infectious disease or immune system deficiency including AIDS.

•History of intolerance/hypersensitivity to methotrexate.

•Subjects who have used any investigational drugs within 4 weeks of Screening or are participating in other clinical studies

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢The change in PASI (Psoriasis Area and Severity Index) scores of the patients as measured at baseline and at week 12.Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Serum level of certain cytokines in patients at baseline and at 12 weeksTimepoint: 12 weeks;The change in Physicians Global Assessment (PGA) Score of the patients as measured at baseline and at week 12. <br/ ><br>Timepoint: 12 weeks