Randomised controlled assessor- blind trial to compare the efficacy of tofacitinib v/s methotrexate in patients with moderate to severe atopic dermatitis.

Randomised controlled assessor-blind trial to compare the efficacy of tofacitinib v/s methotrexate in patients with moderate to severe atopic dermatitis - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062367

Enrollment

Registered

2024-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: L209- Atopic dermatitis, unspecified

Interventions

Intervention1: TOFACITINIB: For administration of tofacitinib oral solution (1 mg/mL clear, colorless oral solution) will be given for body weight 40 kg ? 10 kg body weight 20 kg: 3.2 mg( 3.2 ml or

Eligibility

Inclusion criteria

Inclusion criteria: Patients >2 years of age with moderate to severe atopic dermatitis (SCORAD >25)

Exclusion criteria

Exclusion criteria: 1. Patients with latent and active tuberculosis. 2. Patients receiving systemic immunosuppressive therapy in last 1 month. 3. Patients unable to come for follow up. 4. History of immunization with live vaccines in last 4 weeks. 5. Pregnant and lactating females. 6. Patients with history of thromboembolic phenomenon or on anti-coagulants.

Design outcomes

Primary

Measure	Time frame
Reduction in SCORAD in patients with moderate to severe AD receiving tofacitinib v/s methotrexate.Timepoint: 3 months	—

Secondary

Measure	Time frame
i. Difference in time to remission( SCORAD less than 10) & difference in disease free duration in patients with moderate to severe atopic dermatitis receiving tofacitinib as compared to methotrexate.Timepoint: 3 months;ii. Quality of life comparison between patients receiving tofacitinib & methotrexateTimepoint: 3 months;iii. Safety profile comparison between tofacitinib & methotrexate.Timepoint: 3 month	—

Measure

Time frame

i. Difference in time to remission( SCORAD less than 10) & difference in disease free duration in patients with moderate to severe atopic dermatitis receiving tofacitinib as compared to methotrexate.Timepoint: 3 months;ii. Quality of life comparison between patients receiving tofacitinib & methotrexateTimepoint: 3 months;iii. Safety profile comparison between tofacitinib & methotrexate.Timepoint: 3 month

—

Countries

India

Contacts

Public ContactDr Neetu Bhari

All India Instititute of Medical Sciences, Delhi

drntbhari@gmail.com01126594985

Outcome results

None listed

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