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

• ClinicalTrials.gov Identifier: NCT04042792
• Recruitment Status: Completed
• First Posted: August 2, 2019
• Last Update Posted: December 1, 2021
• Sponsor: University Hospital, Basel, Switzerland
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

Tracking Information

• First Submitted Date: July 31, 2019
• First Posted Date: August 2, 2019
• Last Update Posted Date: December 1, 2021
• Actual Study Start Date: September 26, 2019
• Actual Primary Completion Date: June 28, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 31, 2019)

• 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)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
• Official Title: Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate (ADA in PiRD)
• 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).
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Rheumatic Diseases

Intervention

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)

Study Groups/Cohorts

• ADA for ≥12 weeks and concomitant MTX therapy
  PiRD patients with ADA for ≥12 weeks and concomitant MTX therapy (oral or subcutaneous)
  Intervention: 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)
  Intervention: Other: pharmacokinetics (PK) measurement

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 31, 2019): 28
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 28, 2021
• Actual Primary Completion Date: June 28, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Switzerland

Administrative Information

• NCT Number: NCT04042792
• Other Study ID Numbers: 2019-00916; ks18Pfister2
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Basel, Switzerland
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Basel, Switzerland
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital, Basel, Switzerland
• Verification Date: November 2021