Rheumatic DiseasesADA in PiRDNCT04042792
Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
An observational study of Rheumatic Diseases, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- pharmacokinetics (PK) measurement
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 28 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Sep 2019to 28 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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
- Other rheumatic inflammatory diseases
Show all 9Show fewer
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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).
- Conditions
- Rheumatic Diseases
- Being tested
- pharmacokinetics (PK) measurement
- Keywords
- pharmacokinetics, pharmacodynamics, Adalimumab, methotrexate, drug-drug interaction, trough ADA concentration, peak ADA concentration, Pediatric inflammatory rheumatic diseases
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| ADA for ≥12 weeks and concomitant MTX therapy | PiRD patients with ADA for ≥12 weeks and concomitant MTX therapy (oral or subcutaneous) Receives: 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) Receives: Other: pharmacokinetics (PK) measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADA concentration (in mg/L)
ADA concentration (in mg/L)
Measured: at study inclusion
ADA concentration (in mg/L)
ADA concentration (in mg/L)
Measured: during regular clinical follow up 3-6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start26 Sep 2019
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Pfister, Prof. Dr., Principal investigator, University Children's Hospital Basel (UKBB), University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042792
- Sponsor's protocol ID
- 2019-00916; ks18Pfister2
- Other IDs
- 2019
- Acronym
- ADA in PiRD
- Status last verified
- Nov 2021
- First submitted
- 31 Jul 2019
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38167019
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate (ADA in PiRD)
- ClinicalTrials.gov ID
- NCT04042792
- Acronym / sponsor ID
- ADA in PiRD / 2019-00916; ks18Pfister2
- Conditions
- Rheumatic Diseases
- Keywords
- pharmacokinetics, pharmacodynamics, Adalimumab, methotrexate, drug-drug interaction, trough ADA concentration, peak ADA concentration, Pediatric inflammatory rheumatic diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADA for ≥12 weeks and concomitant MTX therapy | – | Other: pharmacokinetics (PK) measurementPiRD patients with ADA for ≥12 weeks and concomitant MTX therapy (oral or subcutaneous) |
| ADA for ≥ 12 weeks without MTX | – | Other: pharmacokinetics (PK) measurementPiRD patients with ADA for ≥ 12 weeks without MTX ≥ 12 weeks (or never exposed to MTX) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacokinetics (PK) measurementtwo 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) | Other | ADA for ≥ 12 weeks without MTX, ADA for ≥12 weeks and concomitant MTX therapy |
Primary outcome
ADA concentration (in mg/L)
Time frame: at study inclusion
ADA concentration (in mg/L)
ADA concentration (in mg/L)
Time frame: during regular clinical follow up 3-6 months after inclusion
ADA concentration (in mg/L)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Derived from this study: PubMed 38167019Welzel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Pfister, Prof. Dr. principal investigator
University Children's Hospital Basel (UKBB), University of Basel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADA concentration (in mg/L) (time frame: at study inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.