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Can a common arthritis drug ease MPS pain? new trial seeks answers.

NCT ID NCT03153319

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adalimumab, a drug used for arthritis, can reduce pain and improve joint movement in people with MPS I, II, or VI. It includes children and adults aged 5 and older who have significant pain and limited joint motion. Participants receive either adalimumab or a placebo for 16 weeks, then all may receive the drug for up to a year. The goal is to see if the drug improves daily life and physical function.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2017

Expected to finish

Feb 2027

An estimate. End dates often move.

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

5 years and older

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: * Male or female ≥5 years of age; * Diagnosis of MPS I, II or VI; * Treatment with ERT for ≥1 year or no treatment with ERT for ≥1 year; * Weight ≥15 kg; * Significant bodily pain reported by the CHQ-PF50 or SF-36 (\> 1 SD more severe \[below\] than the general population mean); * ≥ 3 joints with limitations in motion; and Patient or parent/legal guardian is able and willing to provide informed consent. For patients 7 to 17 years of age, assent must also be provided. Exclusion Criteria: * History of HCT less than 2 years prior to enrollment; * Immune suppression therapy less than 1 year prior to enrollment; * Active graft versus host disease; * Current diagnosis or history of lymphoma or other malignancy; * Current active infection; * History of serious opportunistic infection (e.g., bacterial \[Legionella and Listeria\]; tuberculosis \[TB\]; invasive fungal infections; or viral, parasitic, and other opportunistic infections); * Positive TB skin test, positive Quantiferon-TB Gold TB test, positive chest X-ray, or a recent exposure to TB * Congestive heart failure defined by an ejection fracture \<50% measured by ECHO; * Demyelinating disorders (e.g., central nervous system \[CNS\] disorders including multiple sclerosis and optic neuritis and peripheral nervous system disorders including Guillain-Barre syndrome); * Hematologic abnormalities (e.g., pancytopenia, aplastic anemia); * Hepatitis B infection (active or chronic carrier); * Latex sensitivity; * Pregnancy or breastfeeding; * Known or suspected allergy to adalimumab or related products; * Participation in simultaneous therapeutic study that involves an investigational study drug or agent within 4 weeks of study enrollment; * Requirement for live vaccine exposure that would be expected to occur during the time frame of the study; or * Any other social or medical condition that the Investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated or be detrimental to the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • The Lundquist Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

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