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Comparison of Oral Versus Subcutaneous Route of Methotrexate Administration in Moderate to Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT03408756
Recruitment Status : Not yet recruiting
First Posted : January 24, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Tarun Narang, Postgraduate Institute of Medical Education and Research

Brief Summary:

This study is a prospective, single blinded, randomized, pilot study to compare the effectiveness and safety profile of oral versus subcutaneous route of administration of methotrexate in management of patients with moderate to severe psoriasis. The recruited participants with moderate to severe psoriasis will be randomized into treatment arms. Randomization will be done using computer generated random number table. The participants in the first treatment arm will receive 0.3 mg/kg ( upto a maximum of 25 mg/week ) of weekly oral methotrexate for 12 weeks or achievement of PASI 90 whichever is earlier while the participants in second treatment arm will receive subcutaneous methotrexate at 0.3 mg/kg/week for the same duration. The participants will be followed at regular intervals and monitored adequately for hematological, hepatotoxic and other adverse effects both clinically and through laboratory investigations according to methotrexate consensus guidelines during the treatment period. PASI, percentage of body surface area (BSA) involvement and DLQI will be assessed at each follow up visit and at the end of 12 weeks. The treatment will be tapered at the rate of 5 mg/2 weeks and stopped after 12 weeks or achievement of PASI 90 whichever is earlier.. Follow ups will be done at every 2 weeks until treatment completion (12 weeks) and at every 4 weeks till 24 weeks after completion of treatment.

The primary outcome measures will be achievement of PASI 90 (90 % reduction in psoriasis area severity score (PASI) compared to baseline).The secondary outcomes will be improvement in DLQI (dermatology life quality index), relapse rate and adverse events if any.


Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: methotrexate Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Efficacy and Safety Profile of Oral Versus Subcutaneous Route of Methotrexate Administration in Moderate to Severe Psoriasis
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: Oral Methotrexate
Participants will receive methotrexate through oral route of administration
Drug: methotrexate
Participants will receive methotrexate through oral or subcutaneous route of administration
Other Names:
  • Folitrax
  • neotrexate

Active Comparator: Subcutaneous Methotrexate
Participants will receive methotrexate through subcutaneous route of administration
Drug: methotrexate
Participants will receive methotrexate through oral or subcutaneous route of administration
Other Names:
  • Folitrax
  • neotrexate




Primary Outcome Measures :
  1. Achievement of PASI 90 [ Time Frame: 12 weeks ]
    PASI 90 refers to 90 % reduction in psoriasis area severity score (PASI) compared to baseline


Secondary Outcome Measures :
  1. Improvement in DLQI (dermatology life quality index) [ Time Frame: 12 weeks ]
    Improvement in DLQI (dermatology life quality index) as compared to baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged more than 18 years with clinical diagnosis of plaque psoriasis
  2. Patients with body surface area involvement > 10 %, PASI >10, DLQI >10.

Exclusion Criteria:

  1. Hemoglobin < 8 gm/dl ,Total leukocyte count < 3500/ mm3, Platelet count < 100,000/mm3
  2. Elevation of hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or γ glutamyl transferase [GGT]) to more than twice the upper limit of normal.
  3. Hepatitis, active or recurrent, cirrhosis or excessive current alcohol intake .
  4. Use of other hepatotoxic drugs by the patient
  5. Positive hepatitis B, hepatitis C or HIV serology
  6. Pulmonary or extra-pulmonary active tuberculosis
  7. Deranged renal function test.
  8. Pregnancy or lactation or if patient is planning to conceive during the treatment period.
  9. Patient on other immunosuppressive drugs
  10. Recent live vaccination
  11. Unreliable patient
  12. Patients unwilling for monthly follow-ups. -

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): NCT03408756


Contacts
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Contact: Tarun Narang, MD 911172-2756564 narangtarun@yahoo.co.in
Contact: Sheetanshu Kumar, MD 919914211066 kumar.sheetanshu@gmail.com

Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Tarun Narang, MD PGIMER Chandigarh

Publications:

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Responsible Party: Dr. Tarun Narang, Assistant Professor of Dermatology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03408756     History of Changes
Other Study ID Numbers: INT/IEC/2017/961
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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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