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

NCT07386587 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: 914/CH-UCHS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Juvenile Idiopathic Arthritis

Keywords

JIA

Outcome Measures

Primary Outcomes (1)

• Achievement of Minimal/Low Disease Activity Level in Polyarticular JIA

  Proportion of patients achieving minimal/Low disease activity based on JDAS-10 between 0.8 t0 3.9 in Polyarticular Juvenile Idiopathic Arthritis.

  24 weeks

Study Arms (2)

Group A

EXPERIMENTAL

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.

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)

Group B

ACTIVE COMPARATOR

Group B Includes those patients who fulfills inclusive criteria and given Tablet methotrexate 10-15mg/m2/week orally alone

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)

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.

Group A; Group B

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Polyarticular JIA patients aged 2-16years Male or female patients Newly diagnosed patients

You may not qualify if:

• Other type of JIA including systemic-onset JIA, psoriatic arthritis, enthesitis-related arthritis, and oligoarticular arthritis Chronic or acute infection or severe infection episodes that required hospitalization or intravenous administration of antibiotics 30 days prior to study initiation A previous history of malignancy Active tuberculosis or any opportunistic infection, including herpes zoster Hepatitis B Positive patients A history of any chronic disease (except for JIA) that could influence the effectiveness or safety of the investigational medicinal product in investigator's opinion

Sponsors & Collaborators

• University of Child Health Sciences and Children's Hospital, Lahore: lead

Study Sites (1)

University of Child Health Sciences Lahore, The Children's hospital Lahore

Lahore, Punjab Province, 54600, Pakistan

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Injections; Etanercept; Nuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Orphan Nuclear Receptors; DNA-Binding Proteins; Receptors, Cytoplasmic and Nuclear

Study Officials

• Faisal Haneef

  University of Child Health Sciences Lahore.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study, No masking both the participants and the investigators, including care providers and outcome assessors, are aware of the treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Trainee

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): July 27, 2026
• Study Completion (Estimated): July 27, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)