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

This study has been completed.
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01187264
First received: August 23, 2010
Last updated: August 24, 2010
Last verified: September 2009
History of Changes

August 23, 2010
August 24, 2010
August 2008
September 2009   (final data collection date for primary outcome measure)
change in Psoriasis Area and Severity Index (PASI) score between two groups from baseline to 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01187264 on ClinicalTrials.gov Archive Site
  • time to achieve PASI 75 [ Time Frame: 12 weeks or earlier ] [ Designated as safety issue: No ]
  • number of patients achieving PASI 90 and 100 [ Time Frame: 12 weeks or earlier ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
Drug: Methotrexate
once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75
  • Active Comparator: methotrexate 10 mg
    oral methotrexate 10 mg once weekly
    Intervention: Drug: Methotrexate
  • Active Comparator: methotrexate 25mg
    oral methotrexate 25 mg once weekly
    Intervention: Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01187264
7557/PG/2Trg/07
Yes
Dr C Vijay Krishna, postgraduate institute of medical education and research
Postgraduate Institute of Medical Education and Research
Not Provided
Principal Investigator: C V KRISHNA, MD Postgraduate Institute of Medical Education and Research
Study Chair: SUNIL DOGRA, MD Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP