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A comparison of efficacy and safety of oral tofacitinib vs methotrexate in management of moderate to severe chronic plaque psoriasis

A study of Efficacy and safety of oral tofacitinib vs methotrexate in management of moderate to severe chronic plaque psoriasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053443
Enrollment
108
Registered
2023-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: L400- Psoriasis vulgaris Health Condition 2: L400- Psoriasis vulgaris

Interventions

Intervention1: Tofacitinib: Patient alloted in this arm will be given T.tofacitinib 5mg BD daily for 6 months Control Intervention1: Methotrexate: Patient allotted in this arm will be given T. Methotr

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex and age 18-70 years. 2. PASI >12 or BSA >10%

Exclusion criteria

Exclusion criteria: 1. Age less than 18 or more than 70 years 2. Individuals with severe anaemia, leukopenia(lymphocytes 3. Individuals with heavy alcohol consumption ( >14 units/week) or heavy smokers. 4. Individuals on concomitant medications such as high dose vitamin D, oral/topical steroids, PUVA, Acitretin, Dapsone, Sulfamethoxazole, Trimethoprim 5. Pregnant and lactating women 6. Patient having pre-existing uncontrolled Diabetes mallitus , Hypertension 7. Patients who have taken any immunosuppressant drugs, homeopathic/herbal medications in last 4 weeks. 8. Patients with malignancies/ history of malignancy. 9. Patients with risk/history of thromboembolism, cardiovascular accidents. 10. Patients with active infection, active/latent tuberculosis. 11. Patients found to have abnormal laboratory parameters that would increase the risk of adverse effect

Design outcomes

Primary

MeasureTime frame
improvement in PASI by 75% from baseline at 12 weekTimepoint: improvement in PASI by 75% from baseline at 12 week

Secondary

MeasureTime frame
Improvement in PASI by 100% from baseline Physicians global assessment Dermatological Quality of life Index Safety analysisTimepoint: At 24 week

Countries

India

Contacts

Public ContactDrJahnvi Patel

GCS Medical College, Hospital and Research Centre

ranjanmb@yahoo.com09426016111

Outcome results

None listed

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