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

NCT03408756 | Unknown Phase 4

• 1 other identifier: INT/IEC/2017/961
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Achievement of PASI 90

  PASI 90 refers to 90 % reduction in psoriasis area severity score (PASI) compared to baseline

  12 weeks

Secondary Outcomes (1)

• Improvement in DLQI (dermatology life quality index)

  12 weeks

Study Arms (2)

Oral Methotrexate

ACTIVE COMPARATOR

Participants will receive methotrexate through oral route of administration

Drug: methotrexate

Subcutaneous Methotrexate

ACTIVE COMPARATOR

Participants will receive methotrexate through subcutaneous route of administration

Drug: methotrexate

Interventions

methotrexate DRUG

Participants will receive methotrexate through oral or subcutaneous route of administration

Also known as: Folitrax, neotrexate

Oral Methotrexate; Subcutaneous Methotrexate

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (7)

• Roenigk HH Jr, Auerbach R, Maibach H, Weinstein G, Lebwohl M. Methotrexate in psoriasis: consensus conference. J Am Acad Dermatol. 1998 Mar;38(3):478-85. doi: 10.1016/s0190-9622(98)70508-0. No abstract available.

  PMID: 9520032 BACKGROUND

• Kalb RE, Strober B, Weinstein G, Lebwohl M. Methotrexate and psoriasis: 2009 National Psoriasis Foundation Consensus Conference. J Am Acad Dermatol. 2009 May;60(5):824-37. doi: 10.1016/j.jaad.2008.11.906.

  PMID: 19389524 BACKGROUND

• Montaudie H, Sbidian E, Paul C, Maza A, Gallini A, Aractingi S, Aubin F, Bachelez H, Cribier B, Joly P, Jullien D, Le Maitre M, Misery L, Richard MA, Ortonne JP. Methotrexate in psoriasis: a systematic review of treatment modalities, incidence, risk factors and monitoring of liver toxicity. J Eur Acad Dermatol Venereol. 2011 May;25 Suppl 2:12-8. doi: 10.1111/j.1468-3083.2011.03991.x.

  PMID: 21388454 BACKGROUND

• Schiff MH, Jaffe JS, Freundlich B. Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses >/=15 mg may be overcome with subcutaneous administration. Ann Rheum Dis. 2014 Aug;73(8):1549-51. doi: 10.1136/annrheumdis-2014-205228. Epub 2014 Apr 12.

  PMID: 24728329 BACKGROUND

• Bianchi G, Caporali R, Todoerti M, Mattana P. Methotrexate and Rheumatoid Arthritis: Current Evidence Regarding Subcutaneous Versus Oral Routes of Administration. Adv Ther. 2016 Mar;33(3):369-78. doi: 10.1007/s12325-016-0295-8. Epub 2016 Feb 4.

  PMID: 26846283 BACKGROUND

• Warren RB, Mrowietz U, von Kiedrowski R, Niesmann J, Wilsmann-Theis D, Ghoreschi K, Zschocke I, Falk TM, Blodorn-Schlicht N, Reich K. An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Feb 4;389(10068):528-537. doi: 10.1016/S0140-6736(16)32127-4. Epub 2016 Dec 22.

  PMID: 28012564 BACKGROUND

• Yesudian PD, Leman J, Balasubramaniam P, Macfarlane AW, Al-Niaimi F, Griffiths CE, Burden AD, Warren RB. Effectiveness of Subcutaneous Methotrexate in Chronic Plaque Psoriasis. J Drugs Dermatol. 2016 Mar;15(3):345-9.

  PMID: 26954320 BACKGROUND

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

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

Study Officials

• Tarun Narang, MD

  PGIMER Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarun Narang, MD

CONTACT

911172-2756564; narangtarun@yahoo.co.in

Sheetanshu Kumar, MD

CONTACT

919914211066; kumar.sheetanshu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: April 1, 2018
• Primary Completion: October 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share