Comparison of efficacy and safety of oral vs subcutaneous methotrexate in psoriasis

Not yet recruiting

• Conditions: Psoriasis Vulgaris

• Registration Number: CTRI/2018/01/011373
• Lead Sponsor: Postgraduate Institute of Medical Education and Research

Brief Summary

This study is a prospective, doubleblinded, randomized, parallel group study to  compare the effectiveness and safety profileof oral versus subcutaneous route of administration of methotrexate inmanagement of patients with moderate to severe psoriasis. The recruitedpatients will be randomized into treatment arms. Randomization will be doneusing computer generated random number table.The patients in first treatmentarm will receive 0.3 mg/kg (upto a maximum of 25 mg/week )  of weekly oral  methotrexate for 12 weeks or achievement ofPASI 90 whichever is earlier while the patients in second treatment arm will receive subcutaneous methotrexateat 0.3 mg/kg/week  for the same duration.The patients will be followed at regular intervals and monitored adequately forhematological, hepatotoxic and other adverse effects both clinically andthrough laboratory investigations according to methotrexate consensusguidelines during the treatment period. PASI, Body surface area (BSA)involvement and DLQI will be assessed at each follow up visit and at the end of12 weeks. The treatment will be tapered at the rate of 5 mg/2 weeks and stoppedafter 12 weeks or achievement of PASI 90 whichever is earlier.. Follow ups willbe done at every  2weeks until treatmentcompletion (12 weeks) and at every 4 weeks till 24 weeks after completion oftreatment.

The primary outcome measures will beachievement 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Last Update Posted: 2018-01-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

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,.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in the percentage of patients who achieved PASI 90 (90 % reduction in psoriasis area severity score (PASI) compared to baseline) in both the groups	0 Weeks and 12 Weeks

Secondary Outcome Measures

Name	Time	Method
1.Improvement in DLQI (dermatology life quality index).	2.Relapse free period after stopping treatment.

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Postgraduate Institute of Medical Education and Research

🇮🇳Chandigarh, CHANDIGARH, India

Dr Tarun Narang

Principal investigator

9316063166

narangtarun@yahoo.co.in