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Completed

NCT Number: NCT01187264

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

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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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Postgraduate Institute of Medical Education and Research

Chandigarh, U.T, 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methotrexate

Drug

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

Primary outcomes

  1. change in Psoriasis Area and Severity Index (PASI) score between two groups from baseline to 12 weeks

    Time frame: 12 weeks

Secondary outcomes

  1. time to achieve PASI 75

    Time frame: 12 weeks or earlier

  2. number of patients achieving PASI 90 and 100

    Time frame: 12 weeks or earlier

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 24, 2010
Registry last updated
Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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