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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADA for ≥12 weeks and concomitant MTX therapy | PiRD patients with ADA for ≥12 weeks and concomitant MTX therapy (oral or subcutaneous) |
| |
| ADA for ≥ 12 weeks without MTX | PiRD patients with ADA for ≥ 12 weeks without MTX ≥ 12 weeks (or never exposed to MTX) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacokinetics (PK) measurement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Marc Pfister, Prof. Dr. | University Children's Hospital Basel (UKBB), University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Tubingen | Tübingen | 72076 | Germany | |||
| University of Basel Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38167019 | Derived | 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. |
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| Basel |
| 4031 |
| Switzerland |
| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D010599 | Pharmacokinetics |
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008660 | Metabolism |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
| D008919 | Investigative Techniques |
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