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

January 27, 2026 updated by: Dr Faisal Haneef, University of Child Health Sciences and Children's Hospital, Lahore

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54600
        • University of Child Health Sciences Lahore, The Children's hospital Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Active Comparator: Group B
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)
Injection Etanercept is biological TNF Inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of Minimal/Low Disease Activity Level in Polyarticular JIA
Time Frame: 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Faisal Haneef, University of Child Health Sciences Lahore.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2026

Primary Completion (Estimated)

July 27, 2026

Study Completion (Estimated)

July 27, 2026

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 914/CH-UCHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because of participants consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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