Comparing efficacy of oral immunosuppressants in patients with moderate to severe psoriasis

Clinical and Biomarker evaluation of response to oral immunosuppressants in Moderate to Severe Psoriasis - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068034

Enrollment

Registered

2024-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: L409- Psoriasis, unspecified

Interventions

Intervention1: Methotrexate: 15 mg Methotrexate will be given orally once weekly, as a single dose in a tablet form Intervention2: Methotrexate: 15 mg Methotrexate orally in tablet form, once weekly,

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed patients with moderate to severe psoriasis 2. Patients aged 18 - 60 years 3. PASI score of = 5 or Body surface area involvement of = 10% 4. Patients providing informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled or major forms of psoriasis which are life threatening 2. Patients on active topical agents 3. Patients taking other systemic drugs for psoriasis in last 2 months 4. Patient taking other drugs which can interfere with Methotrexate or Apremilast or Cyclosporine 5. Patients on biologics within the past 2 weeks 6. Patients with liver or renal impairment or anaemia or thrombocytopenia or leukopenia 7. Patients with hepatitis B, C, HIV or TB infection 8. Patients with a co-existing comorbidity like diabetes mellitus, uncontrolled hypertension and psychiatric illness 9. Pregnant and breastfeeding patients

Design outcomes

Primary

Measure	Time frame
1. To compare efficacy of oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis patients by evaluating changes in Psoriasis Area and Severity Index (PASI) score. 2. To evaluate and compare changes in Biomarkers- cytokines like IL 1, IL 17 and TNF a from baseline associated with pathology of psoriasis treated with oral Methotrexate versus oral Apremilast versus oral Cyclosporine.Timepoint: 18 months	—

Measure

Time frame

1. To compare efficacy of oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis patients by evaluating changes in Psoriasis Area and Severity Index (PASI) score. 2. To evaluate and compare changes in Biomarkers- cytokines like IL 1, IL 17 and TNF a from baseline associated with pathology of psoriasis treated with oral Methotrexate versus oral Apremilast versus oral Cyclosporine.Timepoint: 18 months

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Secondary

Measure	Time frame
1. To compare changes in Dermatology Life Quality Index (DLQI) score with oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis patients. 2. To assess the adverse drug reactions, safety & tolerability of oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis. 3. To evaluate histological changes after treatment.Timepoint: 18 months	—

Measure

Time frame

1. To compare changes in Dermatology Life Quality Index (DLQI) score with oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis patients. 2. To assess the adverse drug reactions, safety & tolerability of oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis. 3. To evaluate histological changes after treatment.Timepoint: 18 months

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Countries

India

Contacts

Public ContactDr Surbhi Jain

Jawaharlal Nehru Medical College, Aligarh Muslim University

irfan1308@gmail.com9997448504

Outcome results

None listed

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