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

Phase 4

Completed

• Conditions: Psoriasis
• Interventions: Drug: Methotrexate

• Registration Number: NCT01187264
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Last Update Submitted: 2010-08-24
• Last Update Posted: 2010-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methotrexate 10 mg	Methotrexate	oral methotrexate 10 mg once weekly
methotrexate 25mg	Methotrexate	oral methotrexate 25 mg once weekly

Primary Outcome Measures

Name	Time	Method
change in Psoriasis Area and Severity Index (PASI) score between two groups from baseline to 12 weeks	12 weeks

Secondary Outcome Measures

Name	Time	Method
time to achieve PASI 75	12 weeks or earlier
number of patients achieving PASI 90 and 100	12 weeks or earlier

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, U.T, India