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Can a common arthritis drug tame the painful Flare-Ups of leprosy?

NCT ID NCT07806357

Disease control Sponsor: Chittagong Medical College 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether adding methotrexate to the standard steroid prednisolone better controls erythema nodosum leprosum (ENL), a painful and often recurring complication of leprosy. Adults aged 18 to 65 with active ENL will receive either prednisolone alone or prednisolone plus low-dose methotrexate for several months. Researchers will compare how well each treatment reduces tender skin nodules and other symptoms. The goal is to find a safer, more effective way to manage ENL and reduce the need for high-dose steroids.

What this could mean

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

Active substance
Methotrexate added to prednisolone, compared with prednisolone alone
What this could lead to
If adding methotrexate works better, it could offer a safer, cheaper way to control painful leprosy reactions and reduce the need for long-term steroids.
What could go wrong
This is a small early-stage trial, so results may not apply broadly. Methotrexate can cause side effects like liver or blood problems, and the added benefit over steroids alone is not yet proven.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

19 people

The number who actually took part.

Started

Jun 2018

Finished

Dec 2019

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

18 to 65 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: 1. Patient with ENL had crops of tender subcutaneous skin lesions with systemic features including fever (temperature \>38°C), neuritis, joint pain, bone tenderness, orchitis, iritis, oedema, malaise, anorexia and lymphadenopathy. 2. Patients of both sexes with age ranging 18 years to 65 years. Exclusion criteria: 1. Erythema nodosum associated with other disorder. 2. Pregnant and lactating women. 3. Diagnosed case of chronic hepatic, renal, hematological or other connective tissue disorders, Osteoporosis. 4. Severely ill, immune-suppressed patients like HIV/AIDS and patients of internal malignancy. 5. Patients or guardians not willing to participate in the study by signing informed consent form.

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Conditions

The condition(s) this trial relates to.

leprosy

As listed by the trial registrant

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

Leprosy

Contacts and locations

Locations

  • Chittagong Medical College

    Chittagong, 4203, Bangladesh

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