Methotrexate Alone vs Methotrexate + Etanercept for Minimal/Low Disease Activity in Juvenile Idiopathic Arthritis

Sponsor
University of Child Health Sciences and Children's Hospital, Lahore
Study ID
NCT07386587
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 16 Years
Healthy Volunteers
Accepted

Interventions

  • Injection, Etanercept, 25 Mg (Code May Be Used for Medicare When Drug Administered Under the Direct Supervision of A Physician, Not for Use When Drug is Self Administered) — DRUG
    Injection Etanercept is biological TNF Inhibitor.

Study Details

This open labelled randomized controlled trial will be carried out at the University of Child Health and the Children's Hospital, Lahore consisting of 6 months . In total 60 patients (30 in each group) fulfilling the inclusion criteria will be selected and enrolled in this study. Patients will be divided into two groups; Group A (Injection Etanercept+ Tab methotrexate) and Group B (Injection Etanercept+ Tab methotrexate). Data will be collected at baseline, 1,3 and 6 months. Data will be collected and recorded

Key Dates

Start date
Jan 27, 2026
Status verified
Jan 2026
Primary completion
Jul 27, 2026
Completion
Jul 27, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Group A Includes those patients who fulfills inclusive criteria and given Tablet methotrexate 10-15mg/m2/week orally along with Injection Etanercept 0.8mg/kg/week subcutaneously.
  • Active Comparator: Group B
    Group B Includes those patients who fulfills inclusive criteria and given Tablet methotrexate 10-15mg/m2/week orally alone

Primary Outcome Measure

Achievement of Minimal/Low Disease Activity Level in Polyarticular JIA [ Time Frame: 24 weeks ]

Related Studies