FindTrial
Sign In

Comparing two treatment approaches for children with Systemic Juvenile Idiopathic Arthritis

Randomised Control Trial to Compare Clinical Outcomes in Children with Systemic Juvenile Idiopathic Arthritis Treated Using Tocilizumab With and Without Methotrexate - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094812
Enrollment
30
Registered
2025-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: M082- Juvenile rheumatoid arthritis withsystemic onset

Interventions

Intervention1: Group A: Tocilizumab only: a)Start b)Ethics Approval + CTRI Registration c)Patient Screening (Children under 12 years with sJIA) d)Apply Inclusion & Exclusion Criteria e)Obtain Info

Sponsors

Samiparna Chakraborty
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Children upto 12 years of age at the time of diagnosis admitted in department of Paediatric Medicine at IPGMER and SSKM Hospital Kolkata 2) Confirmed diagnosis of systemic Juvenile Idiopathic Arthritis based on ILAR (International League of Associations for Rheumatology) classification criteria

Exclusion criteria

Exclusion criteria: 1) History of hypersensitivity or contraindication to Tocilizumab or Methotrexate 2) Presence of other autoimmune or autoinflammatory disorders that may confound diagnosis or outcomes 3) Malignancy or any documented serious infection at the time of Tocilizumab initiation 4) Significant liver or renal dysfunction at baseline 5) Inadequate follow-up data 6) Parents or patients not giving consent or assent respectively

Design outcomes

Primary

MeasureTime frame
To compare the clinical efficacy of Tocilizumab versus Tocilizumab with Methotrexate in children with systemic Juvenile Idiopathic Arthritis, based on achievement of Clinically Inactive Disease (CID) without glucocorticoids at 6 monthsTimepoint: 6 months—

Secondary

MeasureTime frame
1) To evaluate remission and disease flare rates following achievement of CID in each group 2) To compare the cumulative dose of glucocorticoids in both groups of study population 3) To assess the adverse event profiles (frequency of hepatotoxicity, cytopenias, infections) of Tocilizumab with and without Methotrexate 4) To compare trends in inflammatory markers (ESR, Ferritin) between the two groups over timeTimepoint: 6 months, 12 months—

Countries

India

Contacts

Public ContactProf Dr Malay Kumar Sinha

IPGMER and SSKM Hospital Kolkata

drmalaykrsinha@gmail.com9433544203

Outcome results

None listed

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