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Golimumab Dried Blood Spot Analysis (GOUDA)

25 oktober 2017 bijgewerkt door: Universitaire Ziekenhuizen KU Leuven

A Prospective Multi-centric Belgian Trial to Validate the Use of Golimumab Serum Level Analysis Using the Dried Blood Spot (DBS) Methodology

This retrospective multi-centric Belgian prospective trial will involve 10 patients initiating or under maintenance subcutaneous golimumab therapy for moderate-to-severe colitis at the University Hospitals Leuven (Leuven, Belgium) or AZ Groeninge (Kortrijk, Belgium)

Patients will (have) receive(d) standard induction therapy with golimumab 200mg at week 0, and golimumab 100mg at week 2. Maintenance therapy will (have) start(ed) at week 6, with 50 or 100mg of golimumab every 4 weeks, depending on body weight (50mg every 4 weeks for patients with a body weight of less than 80kg, and 100mg for the others)

Patients will come to the hospital for clinical evaluation, blood sampling and golimumab administration following daily clinical practice. The patients will be requested to perform several dry blood spot analyses at home.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

BLOOD SAMPLING:

Blood samples are collected using two sampling methods at different time points (indicated on the timeline above); DBS sampling (max 39 samples/patient) and venous blood sampling (max 13 samples/patient). Venous blood sampling will be performed during a standard outpatient clinic in one of the participating centres, and forwarded to the Laboratory for Therapeutic and Diagnostic Antibodies in Leuven for further analyses. DBS samples will be send directly to the Laboratory for Therapeutic and Diagnostic Antibodies in Leuven through classical mailing.

DBS sampling will be performed by the patient during the outpatient clinic (at same moment as venous punctures, max 13 samples/patient) and at home for the intermediate values (max 26 samples/patient). Patients will be taught how to perform a finger prick during the outpatient clinic. A conversion factor will be defined. Determination of concentration-time profile and exposure of golimumab in the individual patients will be performed by intensive sampling for 3 to 4.5 months. Time point of max concentration, intermediate concentration, and trough concentration will be determined in each patient.

Note: A similar procedure will be adopted to measure free anti-golimumab antibody concentrations on the DBS using a drug sensitive assay. Free anti-golimumab antibody concentrations will be measured when the serum golimumab concentration is below limit of quantification.

MEASUREMENT OF GOLIMUMAB AND ANTI-GOLIMUMAB ANTIBODY CONCENTRATIONS:

Golimumab concentrations will be measured using a sandwich type ELISA, in which golimumab is captured between an immobilized monoclonal antibody towards golimumab (MA-GLM) 171D8 and an added horseradish peroxidase (HRP)-labeled MA-GLM159B8. The assay was developed and validated, analytically (external and internal) and clinically, as described by Detrez et al. Golimumab concentrations will be measured on every sample.

Free anti-golimumab antibody concentrations will be measured using a drug sensitive assay. Total anti-golimumab antibody concentrations will be measured using a drug tolerant assay. Development and validation (analytical + clinical) of these assays is described by Detrez et al. Total anti-golimumab antibody concentrations will be measured on every venous sample. Free anti-golimumab antibody concentrations will be measured when the serum golimumab concentration is below limit of quantification on both venous sample and DBS sample (based on adalimumab serum concentrations measured in by our laboratory, we expect that 11% of samples measured within the first year of treatment have an undetectable golimumab concentration).

BASELINE CHARACTERISTICS:

  • Baseline characteristics will include: sex, age at diagnosis, weight, body mass index, disease extent, smoking status (never, ex, active), primary sclerosing cholangitis, haemoglobin, serum albumin, and C-reactive protein
  • Previous medical characteristics will include previous use of mesalamine, steroids, immunosuppressive agents, ciclosporin, infliximab, adalimumab, vedolizumab, …
  • Current medical characteristics will include use of mesalamine, use of steroids (dosing, duration since initiation), use of immunosuppressive agents (dosing, duration since initiation), use of golimumab (dosing, duration since initiation, last dose), …

QUESTIONNAIRE REGARDING PATIENT FRIENDLINESS:

• At the end of the study the participants will be requested to fill out a questionnaire regarding the patient friendliness of the dried blood spot (DBS) methodology

Studietype

Ingrijpend

Inschrijving (Verwacht)

10

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Leuven, België, 3000
        • UZ Leuven
    • Kortrijk
      • Belgium, Kortrijk, België, 8500
        • AZ Groeninge

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age at least 18 at moment of inclusion
  • Established diagnosis of ulcerative colitis (UC)
  • Patients under golimumab therapy for moderate-to-severe colitis, including minimally 3 patients who will initiate golimumab therapy

Exclusion Criteria:

  • Subjects with Crohn's disease, or IBD type unclassified
  • Subjects who underwent a subtotal colectomy or proctocolectomy

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Cohort A
Patients starting golimumab therapy Week 0: 200 mg Week 2: 100 mg Week 6, 10, 14, and 18: 50 mg (<80 kg) or 100mg (>80 kg body weight)
Ander: Cohort A
Venous sampling (n=13) will be performed in the hospital at D0 (prior to first golimumab injection), D3, D7, D14 (prior to second injection), D28, M0D0 (right before injection at week 6), M0D3, M0D7, M1D0 (4 weeks after M0D0, week 10), M1D3, M1D7, M2D0 (8 weeks after M0D0, week 14), M3D0 (12 weeks after M0D0, week 18) Dried blood spot sampling (n=39) will be performed at D0 (prior to first golimumab injection), D1, D2, D3, D4, D5, D6, D7, D10, D14, D15, D16, D17, D18, D19, D20, D21, D28, D35, M0D0 (right before injection at week 6), M0D3, M0D7, M1D0 (4 weeks after M0D0, week 10), M1D1, M1D3, M1D5, M1D7, M1D9, M1D14, M1D21, M2D0 (8 weeks after M0D0, rig week 14), M2D1, M2D3, M2D5, M2D7, M2D9, M2D14, M2D21, M3D0 (12 weeks after M0D0, week 18)
Andere namen:
  • Monitoring through serum and dry blood spot analysis
Ander: Cohort B
Patients already on golimumab therapy will continue their actual treatment 50 mg every 4 weeks (<80 kg) or 100mg every 4 weeks (>80 kg body weight)
Ander: Cohort B
Venous sampling (n=8) will be performed at M0D0 (right before new golimumab injection), M0D3, M0D7, M1D0 (4 weeks after M0D0, right before next injection), M1D3, M1D7, M2D0 (8 weeks after M0D0, right before next injection), M3D0 (12 weeks after M0D0, right before next injection) Dried blood spot sampling (n=20) will be performed at M0D0 (right before new golimumab injection), M0D3, M0D7, M1D0 (4 weeks after M0D0, right before next injection), M1D1, M1D3, M1D5, M1D7, M1D9, M1D14, M1D21, M2D0 (8 weeks after M0D0, right before next injection), M2D1, M2D3, M2D5, M2D7, M2D9, M2D14, M2D21, M3D0 (12 weeks after M0D0, right before next injection)
Andere namen:
  • Monitoring through serum and dry blood spot analysis

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Comparison of golimumab serum sample through venous puncture and dried blood spot analysis
Tijdsspanne: During 4.5 months for golimumab starters and 3.0 months for patients under golimumab maintenance therapy
The primary objective of this prospective multi-centric Belgian trial is to compare golimumab serum concentrations obtained using venous puncture, with golimumab serum concentrations obtained using DBS sampling and extraction, and to determine its robustness
During 4.5 months for golimumab starters and 3.0 months for patients under golimumab maintenance therapy

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Area under the curve of golimumab exposure during induction therapy
Tijdsspanne: 1.5 months
To determine the area under the curve of golimumab exposure in individual patients with moderate to severe colitis initiating golimumab therapy, by frequent analysis of golimumab serum levels using dried blood spot analysis
1.5 months
Area under the curve of golimumab exposure during maintenance therapy
Tijdsspanne: 3.0 months
To determine the area under the curve of golimumab exposure in individual patients with moderate to severe colitis under maintenance therapy with golimumab by frequent analysis of golimumab serum levels using dried blood spot analysis
3.0 months
Maximum golimumab serum concentration during induction therapy
Tijdsspanne: 1.5 months
To determine the timing of the maximum golimumab concentration in individual patients with moderate to severe colitis initiating golimumab therapy by frequent analysis of golimumab serum levels using dried blood spot analysis
1.5 months
Maximum golimumab serum concentration during maintenance therapy
Tijdsspanne: 3.0 months
To determine the timing of the maximum golimumab concentration in individual patients with moderate to severe colitis under maintenance therapy with golimumab by frequent analysis of golimumab serum levels using dried blood spot analysis
3.0 months
Patient perception question 1: The information I received from my physician and colleagues regarding dried blood spot analyses was adequate
Tijdsspanne: After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Score to check for adequate information. Possible answers: certainly not, no, I don't know, yes, for sure
After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Patient perception question 2: I had fluent access to further information on all aspects of the dried blood spot analysis
Tijdsspanne: After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Score to check for accessibility for extra help. Possible answers: certainly not, no, I don't know, yes, for sure
After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Patient perception question 3: With the provided tools it was easy to get a blood spot on the paper.
Tijdsspanne: After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Score to check for easiness of getting blood spot. Possible answers: certainly not, no, I don't know, yes, for sure
After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Patient perception question 4: With the provided tools it was easy to send/bring the paper with the dried blood spot to the physician/lab
Tijdsspanne: After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Score to check for easiness of getting paper with dried blood spot to the physician/lab. Possible answers: certainly not, no, I don't know, yes, for sure
After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Patient perception question 5: I prefer to perform the dried blood spot at home than to go to the hospital for venous sampling
Tijdsspanne: After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Score to check for preference of dried blood spot analysis over venous sampling. Possible answers: certainly not, no, I don't know, yes, for sure
After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Patient perception question 6: In general this dried blood spot system is user friendly
Tijdsspanne: After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Score to check for userfriendliness of dried blood spot analysis. Possible answers: certainly not, no, I don't know, yes, for sure
After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Medewerkers

General Hospital Groeninge

Onderzoekers

  • Hoofdonderzoeker: Marc Ferrante, MD PhD, Universitaire Ziekenhuizen KU Leuven

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2016

Primaire voltooiing (Verwacht)

1 januari 2018

Studie voltooiing (Verwacht)

1 mei 2018

Studieregistratiedata

Eerst ingediend

12 september 2016

Eerst ingediend dat voldeed aan de QC-criteria

19 september 2016

Eerst geplaatst (Schatting)

22 september 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 oktober 2017

Laatste update ingediend die voldeed aan QC-criteria

25 oktober 2017

Laatst geverifieerd

1 oktober 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • S59372

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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