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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase

Completed

Phase 4

Conditions

Psoriasis

Treatments

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT01187264

7557/PG/2Trg/07

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.