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New combo therapy shows promise for kids with stubborn arthritis

NCT ID NCT07428551

Disease control Sponsor: Bangladesh Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding leflunomide to standard methotrexate treatment helps children with polyarticular juvenile idiopathic arthritis (JIA) that did not improve with methotrexate alone. Fifty children were randomly assigned to receive either the combination or methotrexate alone for 24 weeks. Researchers measured disease activity using the JADAS-27 score and functional impairment using a questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
leflunomide plus methotrexate
What this could lead to
If it works, this combination could offer better disease control for children with JIA who do not respond to methotrexate alone.
What could go wrong
This is a small, single-center trial with only 50 participants. Results may not apply to all patients, and side effects from adding leflunomide are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

50 people

The number who actually took part.

Started

Mar 2024

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 15 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: - All diagnosed cases of Refractory Polyarticular Juvenile Idiopathic Arthritis (JIA) according to ILAR, 2001 unresponsive to methotrexate (at standard dose of 15mg/m² body surface area at least 3-6 months) as monotherapy or together with low dose steroid as bridge therapy who attended Paediatric Rheumatology Division (OPD clinic and inpatient), Department of Paediatrics of BMU, during the study period. Exclusion Criteria: * 1\. A patient with prior or current infectious disorders, including active/latent tuberculosis, and/or H/O chronic or recurrent severe infections, including opportunistic infections. 2\. A patient with leucopenia (White blood cell count \< 3000/mm3), neutropenia (Neutrophil count \< 1000/mm3) and thrombocytopenia (Platelet count \< 100000/mm3). 3\. Serum creatinine \> upper limit of normal reference range. 4. Alanine aminotransaminase (ALT) more than 2 times of upper normal limit. 5. All diagnosed cases of refractory polyarticular JIA who did not give the consent during the study period.

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Conditions

The condition(s) this trial relates to.

juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Refractory polyarticular juvenile idiopathic arthritis

Contacts and locations

Locations

  • Bangladesh Medical University

    Dhaka, Bangladesh

More trials for these conditions

Other studies related to the condition(s) this trial covers.