Comparison of Oral Versus Subcutaneous Route of Methotrexate Administration in Moderate to Severe Psoriasis
Status:
Unknown status
Trial end date:
2019-12-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research