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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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methotrexate 10 mg

oral methotrexate 10 mg once weekly

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75

methotrexate 25mg

oral methotrexate 25 mg once weekly

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75

Interventions

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Methotrexate

once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No