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

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University Hospital Basel

Status

Completed

Conditions

Rheumatic Diseases

Treatments

Other: pharmacokinetics (PK) measurement

Study type

Observational

Funder types

Other

Identifiers

NCT04042792
2019-00916 ks18Pfister2;

Details and patient eligibility

About

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).

Enrollment

28 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

ADA for ≥12 weeks and concomitant MTX therapy
Description:
PiRD patients with ADA for ≥12 weeks and concomitant MTX therapy (oral or subcutaneous)
Treatment:
Other: pharmacokinetics (PK) measurement
ADA for ≥ 12 weeks without MTX
Description:
PiRD patients with ADA for ≥ 12 weeks without MTX ≥ 12 weeks (or never exposed to MTX)
Treatment:
Other: pharmacokinetics (PK) measurement

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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