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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187264
• Other study ID #: 7557/PG/2Trg/07
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2010
• Last updated: August 24, 2010
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh	U.T

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Psoriasis Area and Severity Index (PASI) score between two groups from baseline to 12 weeks		12 weeks	No
Secondary	time to achieve PASI 75		12 weeks or earlier	No
Secondary	number of patients achieving PASI 90 and 100		12 weeks or earlier	No