Trial of oral drug Tofacitinib in juvenile spondyloarthritis

Oral JAK Inhibitor Tofacitinib In Enthesitis Related Arthritis Variant Of Juvenile Idiopathic Arthritis: A Single Center Double Blinded Randomized Control Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048330

Enrollment

Registered

2022-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: M081- Juvenile ankylosing spondylitis

Interventions

Intervention1: Oral Tofacitinib: Dose: 5 mg Frequency: OD/BD (depending on weight- less than 40 kg 5 mg OD, more than 40 kg 5 mg BD) Duration: 16 weeks Route: Oral Plus standard of care (Methotrexat

Eligibility

Inclusion criteria

Inclusion criteria: Children with JIA-ERA with total disease duration 4 and elevated ESR >30 or CRP >6 mg/L while on NSAIDS and Methotrexate for at least 3 months.

Exclusion criteria

Exclusion criteria: Those with active TB/infections, transaminitis ( >3 times ULN), any organ damage, cancer, <5 years of age, inactive disease.

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving ASAS 20 response at week 16 Proportions of patients achieving clinically important improvement in ASDAS-CRP (Decrease of 1.1 from baseline) at week 16.Timepoint: 0, 8, 16 weeks	—

Secondary

Measure	Time frame
Delta BASFI, BASDAI 50 response, jsPADA, BASMI, BASFI, CRP, cytokine levelsTimepoint: 16 weeks	—

Countries

India

Contacts

Public ContactNaveen R

Sanjay Gandhi Postgraduate Institute of Medical Sciences

naviiinr@gmail.com8667688318

Outcome results

None listed

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