Can a common arthritis drug ease MPS pain? new trial seeks answers.
NCT ID NCT03153319
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2017
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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5 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
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Other studies related to the condition(s) this trial covers.
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