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OpenTrials
Completed

NCT Number: NCT04042792

Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate

This study is to assess standardized Adalimumab (ADA) concentrations in Pediatric inflammatory rheumatic diseases (PiRD) patients treated with ADA for ≥ 12 weeks with and without concomitant methotrexate (MTX) therapy and to assess peak and trough ADA concentrations in ADA naïve patients after first ADA administration with and without MTX (pre-phase).

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Key information

Conditions

Rheumatic Diseases Connective Tissue Diseases Musculoskeletal Diseases Skin and Connective Tissue Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Tubingen, Tübingen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of a juvenile idiopathic Arthritis (JIA), uveitis or chronic recurrent multifocal osteomyelitis (CRMO)
  • Medical indication for initiation of ADA treatment or established ADA therapy for ≥ 12 weeks
  • Exclusion of chronic infections
  • No parallel treatment with other biologic medications
  • Available patient history since ADA start
  • No pregnancy
  • Ability to comply with the entire study protocol
  • Willingness to participate with signed informed consent

Exclusion criteria

  • Other rheumatic inflammatory diseases
  • Age < 2 years or >18 years
  • PiRD patients and parents with cognitive impairments preventing to understand study requirements
  • Additional severe chronic disease (kidney failure, liver insufficiency), malignancies or prior chemotherapy

Treatment and study plan

pharmacokinetics (PK) measurement

Other

two ADA-PK samples will be collected during routine rheumatology visits in case of medical indicated blood draw (1 trough PK sample and 1 random PK sample per subject)

Primary outcomes

  1. ADA concentration (in mg/L)

    Time frame: at study inclusion

    ADA concentration (in mg/L)

  2. ADA concentration (in mg/L)

    Time frame: during regular clinical follow up 3-6 months after inclusion

    ADA concentration (in mg/L)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate (ADA in PiRD)

Acronym: ADA in PiRD

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2019
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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