Comparing the Safety and Effectiveness of Methotrexate Alone vs. Methotrexate with Apremilast in Treating Moderate to Severe Psoriasis

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/05/087115
• Lead Sponsor: Dr RPGMC Tanda

Brief Summary

This is a comparative study that intends to study the efficacy and safety of methotrexate monotherapy with combination of methotrexate and apremilast in patients of moderate to severe chronic plaque psoriasis. Patients will be selected based on the eligibility criteria. After obtaining consent detailed history and thorough clinical examination will be performed. They will undergo clinical examination, measurement of weight, blood pressure and blood investigations at each visit.

Patients will be given methotrexate alone or combination of methotrexate and apremilast on alternate basis. PASI score will be measured, side effects relevant to the treatment shall be evaluated on every visit. Patients will be followed up till 13 weeks.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-15
• Study Start: 2025-05-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1 Patients having moderate to severe chronic plaque psoriasis with more than 3 percent of body surface area involved by psoriasis with or without psoriatic arthritis.
• Patients having moderate to severe chronic plaque psoriasis (defined by a score of at least 3 on the Psoriasis Area and Severity Index (PASI).
• Patients of psoriasis not on any form of systemic antipsoriatic treatment for at least 4 weeks and or topical treatment for at least 2 weeks prior to the initiation of therapy.

Exclusion Criteria

• Patients less than 18 years of age.
• Pregnant and or lactating females.
• Patients noncompliant with an effective regimen of contraception 4.
• Hematologic impairment, any acute infection requiring antimicrobial therapy.
• Uncontrolled hypertension or diabetes mellitus, with BMI more than 30, or known psychiatric illness.
• Patients having a history of cancer, including skin cancer or hematologic, cerebral or pulmonary neoplasia.
• Patients who are alcoholic or have a long history of alcohol intake.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Grade of improvement by reduction of PASI score	It will be determined initially at baseline, end of first week, then every two weekly for next four weeks and then every four weekly during the next two months thereafter.

Secondary Outcome Measures

Name	Time	Method
Side effects related to treatment	After each visit

Trial Locations

Locations (1)

Dr. Rajendra Prasad Government Medical College; 🇮🇳 Kangra, HIMACHAL PRADESH, India

Dr. Rajendra Prasad Government Medical College

🇮🇳Kangra, HIMACHAL PRADESH, India

Dr Akanksha

Principal investigator

07807715951

akanksha200077@gmail.com