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

NCT ID: NCT04042792

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-26

Study Completion Date

2021-06-28

Brief Summary

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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).

Detailed Description

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Conditions

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Rheumatic Diseases

Keywords

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pharmacokinetics pharmacodynamics Adalimumab methotrexate drug-drug interaction trough ADA concentration peak ADA concentration Pediatric inflammatory rheumatic diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ADA for ≥12 weeks and concomitant MTX therapy

PiRD patients with ADA for ≥12 weeks and concomitant MTX therapy (oral or subcutaneous)

pharmacokinetics (PK) measurement

Intervention Type 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)

ADA for ≥ 12 weeks without MTX

PiRD patients with ADA for ≥ 12 weeks without MTX ≥ 12 weeks (or never exposed to MTX)

pharmacokinetics (PK) measurement

Intervention Type 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)

Interventions

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pharmacokinetics (PK) measurement

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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Pfister, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Basel (UKBB), University of Basel

Locations

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University Children's Hospital Tubingen

Tübingen, , Germany

Site Status

University of Basel Children's Hospital

Basel, , Switzerland

Site Status

Countries

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Germany Switzerland

References

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Welzel T, Golhen K, Atkinson A, Gotta V, Ternant D, Kuemmerle-Deschner JB, Michler C, Koch G, van den Anker JN, Pfister M, Woerner A. Prospective study to characterize adalimumab exposure in pediatric patients with rheumatic diseases. Pediatr Rheumatol Online J. 2024 Jan 2;22(1):5. doi: 10.1186/s12969-023-00930-8.

Reference Type DERIVED
PMID: 38167019 (View on PubMed)

Other Identifiers

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2019-00916; ks18Pfister2

Identifier Type: -

Identifier Source: org_study_id