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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:
ClinicalTrials.gov Identifier:
NCT01187264
First Posted: August 24, 2010
Last Update Posted: August 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Postgraduate Institute of Medical Education and Research
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • time to achieve PASI 75 [ Time Frame: 12 weeks or earlier ]
  • number of patients achieving PASI 90 and 100 [ Time Frame: 12 weeks or earlier ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 23, 2010
First Posted: August 24, 2010
Last Update Posted: August 25, 2010
Last Verified: September 2009

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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