To compare treatment modalities for moderate to severe plaque psoriasis: tofacitinib once a day with methotrexate once a week, versus taking tofacitinib twice a day.

To compare the efficacy of oral tofacitinib 5 mg once daily (OD) in combination with methotrexate 7.5 mg weekly versus tofacitinib 5 mg twice daily (BD) monotherapy in patients with moderate to severe plaque psoriasis. - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099715

Enrollment

Registered

2025-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Interventions

Intervention1: Tofacitinib with methotrexate: Patients with moderate to severe plaque psoriasis will be treated with tofacitinib 5 mg once daily with weekly methotrexate for 3 months Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: . Patients aged between 18 and 65 years. . Clinically diagnosed cases of moderate to severe chronic plaque psoriasis (PASI more than 10) . Willing to comply with study procedures and follow-up schedule. . Provided written informed consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women. 2.History of drug hypersensitivity to tofacitinib or methotrexate. 3.Patients with active infections, including tuberculosis, HIV, hepatitis B/C. 4:History of malignancy, significant hepatic or renal dysfunction. 5:Use of systemic immunosuppressants or biologics within the last 4 weeks. 6:Alcohol or drug abuse, or inability to adhere to the protocol.

Design outcomes

Primary

Measure	Time frame
PSORIASIS AREA SEVERITY INDEX (PASI)Timepoint: Once every 4 weeks till 12 weeks	—

Secondary

Measure	Time frame
Dermatology Life Quality Index (DLQI) Timepoint: Once every 4 weeks till 12 weeks	—

Countries

India

Contacts

Public ContactPRANAV CHAWLA

Varun Arjun Medical College and Rohilkhand Hospital

dr.niraj1985@gmail.com7759856253

Outcome results

None listed

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