Trials / Completed
CompletedNCT04042792
Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate (ADA in PiRD)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 28 (actual)
- Sponsor
- University Hospital, Basel, Switzerland · Academic / Other
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2019-09-26
- Primary completion
- 2021-06-28
- Completion
- 2021-06-28
- First posted
- 2019-08-02
- Last updated
- 2021-12-01
Locations
2 sites across 2 countries: Germany, Switzerland
Source: ClinicalTrials.gov record NCT04042792. Inclusion in this directory is not an endorsement.