NCT04042792

Brief Summary

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 26, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

July 31, 2019

Last Update Submit

November 30, 2021

Conditions

Rheumatic Diseases

Keywords

pharmacokineticspharmacodynamicsAdalimumabmethotrexatedrug-drug interactiontrough ADA concentrationpeak ADA concentrationPediatric inflammatory rheumatic diseases

Outcome Measures

Primary Outcomes (2)

  • ADA concentration (in mg/L)

    ADA concentration (in mg/L)

    at study inclusion

  • ADA concentration (in mg/L)

    ADA concentration (in mg/L)

    during regular clinical follow up 3-6 months after inclusion

Study Arms (2)

ADA for ≥12 weeks and concomitant MTX therapy

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

Other: pharmacokinetics (PK) measurement

ADA for ≥ 12 weeks without MTX

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

Other: pharmacokinetics (PK) measurement

Interventions

pharmacokinetics (PK) measurementOTHER

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 MTXADA for ≥12 weeks and concomitant MTX therapy

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

PiRD patients treated with ADA for medical reasons at the University Children's Hospital Basel/ Switzerland and at the University Children's Hospital of Tuebingen/ Germany

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Children's Hospital Tubingen

Tübingen, 72076, Germany

Location

University of Basel Children's Hospital

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 38167019DERIVED

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

PharmacokineticsWeights and Measures

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MetabolismPharmacological and Toxicological PhenomenaPhysiological PhenomenaInvestigative Techniques

Study Officials

  • Marc Pfister, Prof. Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

September 26, 2019

Primary Completion

June 28, 2021

Study Completion

June 28, 2021

Last Updated

December 1, 2021

Record last verified: 2021-11

Locations

CH(1)DE(1)