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

November 30, 2021 updated by: University Hospital, Basel, Switzerland

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • University Children's Hospital Tübingen
  • Switzerland
      • Basel, Switzerland, 4031
        • University of Basel Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADA concentration (in mg/L)
Time Frame: at study inclusion
ADA concentration (in mg/L)
at study inclusion
ADA concentration (in mg/L)
Time Frame: during regular clinical follow up 3-6 months after inclusion
ADA concentration (in mg/L)
during regular clinical follow up 3-6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Marc Pfister, Prof. Dr., University Children's Hospital Basel (UKBB), University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 26, 2019

Primary Completion (ACTUAL)

June 28, 2021

Study Completion (ACTUAL)

June 28, 2021

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (ACTUAL)

August 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-00916; ks18Pfister2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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