NCT07386587

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

Response of Methotrexate Alone Versus Methotrexate Combined With Etanercept for Achieving Minimal/Low Disease Activity in Patients of Juvenile Idiopathic Arthritis

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Child Health Sciences and Children's Hospital, Lahore · Academic / Other
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Juvenile Idiopathic Arthritis (JIA) is the primary form of inflammatory arthritis observed in children. JIA is characterized by inflammation of the synovial tissue, which is present in joints, around tendons. The treatment approach for JIA depends on the specific subtype and severity of the disease. It involves the use of various medications, including non-steroidal anti-inflammatory drugs (NSAIDs), oral and intra-articular corticosteroids, as well as both biologic and nonbiologic disease-modifying anti-rheumatic drugs (DMARDs). 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 after approval. 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 (Tab methotrexate Monotherapy). Data will be collected at baseline, 1,3 and 6 months. Data will be collected and recorded on a performa. Data will be analyzed through SPSS version 26. For quantitative variables, mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. chi-square test will be used to estimate the association between qualitative variables. A p-value\<0.05 will be significant. The primary goal of this study is to reduce the duration of active arthritis, improve the quality of life for both patients and their parents, and minimize the risk of irreversible osteoarthritic changes

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	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)	Injection Etanercept is biological TNF Inhibitor.

Timeline

• Start date: 2026-01-27
• Primary completion: 2026-07-27
• Completion: 2026-07-27
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: Pakistan