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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Methotrexate
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Postgraduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

methotrexate 10 mg

methotrexate 25mg

Arm Description

oral methotrexate 10 mg once weekly

oral methotrexate 25 mg once weekly

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

time to achieve PASI 75
number of patients achieving PASI 90 and 100

Full Information

First Posted
August 23, 2010
Last Updated
August 24, 2010
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01187264
Brief Title
Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
methotrexate 10 mg
Arm Type
Active Comparator
Arm Description
oral methotrexate 10 mg once weekly
Arm Title
methotrexate 25mg
Arm Type
Active Comparator
Arm Description
oral methotrexate 25 mg once weekly
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75
Primary Outcome Measure Information:
Title
change in Psoriasis Area and Severity Index (PASI) score between two groups from baseline to 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
time to achieve PASI 75
Time Frame
12 weeks or earlier
Title
number of patients achieving PASI 90 and 100
Time Frame
12 weeks or earlier

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C V KRISHNA, MD
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
SUNIL DOGRA, MD
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Study Chair
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
State/Province
U.T
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

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

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