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
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Methotrexate
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: methotrexate 10 mg
oral methotrexate 10 mg once weekly
Drug: Methotrexate
once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75
Active Comparator: methotrexate 25mg
oral methotrexate 25 mg once weekly
Drug: Methotrexate
once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01187264

Locations
India
Postgraduate Institute of Medical Education and Research
Chandigarh, U.T, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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
  More Information

No publications provided

Responsible Party: Dr C Vijay Krishna, postgraduate institute of medical education and research
ClinicalTrials.gov Identifier: NCT01187264     History of Changes
Other Study ID Numbers: 7557/PG/2Trg/07
Study First Received: August 23, 2010
Last Updated: August 24, 2010
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014