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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Methotrexate

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • U.T
    • Chandigarh, U.T, India, 160012
      • Postgraduate Institute of Medical Education and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
time to achieve PASI 75	12 weeks or earlier
number of patients achieving PASI 90 and 100	12 weeks or earlier

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Study Chair: SUNIL DOGRA, MD, Postgraduate Institute of Medical Education and Research; Principal Investigator: C V KRISHNA, MD, Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: August 23, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (Estimate): August 24, 2010

Study Record Updates

• Last Update Posted (Estimate): August 25, 2010
• Last Update Submitted That Met QC Criteria: August 24, 2010
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate
• Other Study ID Numbers: 7557/PG/2Trg/07