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

To compare efficacy and safety of methotrexate monotherapy with combination of methotrexate and apremilast using standard doses in moderate to severe chronic plaque psoriasis - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087115
Enrollment
50
Registered
2025-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Group A will be given oral methotrexate and folic acid: Oral methotrexate 0.3mg/kg once a week per oral with Folic acid (5mg) supplementation to be given 5 day/week for 13 weeks Control

Sponsors

Dr RPGMC Tanda
Lead Sponsor

Eligibility

Inclusion criteria

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. 2. Patients having moderate to severe chronic plaque psoriasis (defined by a score of at least 3 on the Psoriasis Area and Severity Index (PASI). 3. 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

Exclusion criteria: 1. Patients less than 18 years of age. 2. Pregnant and or lactating females. 3. Patients noncompliant with an effective regimen of contraception 4. Patients having hepatic or renal impairment, deranged lipid profile. Hematologic impairment, any acute infection requiring antimicrobial therapy. Uncontrolled hypertension or diabetes mellitus, with BMI more than 30, or known psychiatric illness. 5. Patients having a history of cancer, including skin cancer or hematologic, cerebral or pulmonary neoplasia. 6. Patients who are alcoholic or have a long history of alcohol intake.

Design outcomes

Secondary

MeasureTime frame
Side effects related to treatmentTimepoint: After each visit

Primary

MeasureTime frame
Grade of improvement by reduction of PASI scoreTimepoint: 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.

Countries

India

Contacts

Public ContactDr Akanksha

Department of DVL, Dr RPGMC Tanda

hoddermatologytanda@gmail.com9418457647

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026