Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis
This study has been completed.
Sponsor:
Postgraduate Institute of Medical Education and Research
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
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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
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 May 16, 2013