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

NCT01187264 | Completed Phase 4 DMC

• 1 other identifier: 7557/PG/2Trg/07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (2)

• time to achieve PASI 75

  12 weeks or earlier

• number of patients achieving PASI 90 and 100

  12 weeks or earlier

Study Arms (2)

methotrexate 10 mg

ACTIVE COMPARATOR

oral methotrexate 10 mg once weekly

Drug: Methotrexate

methotrexate 25mg

ACTIVE COMPARATOR

oral methotrexate 25 mg once weekly

Drug: Methotrexate

Interventions

Methotrexate DRUG

once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75

methotrexate 10 mg; methotrexate 25mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, U.T, 160012, India

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• C V KRISHNA, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• SUNIL DOGRA, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 24, 2010
• Study Start: August 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 25, 2010

Record last verified: 2009-09

Locations

IN (1)