Golimumab Dried Blood Spot Analysis

NCT02910375 | Unknown Phase 4

• 1 other identifier: S59372
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ulcerative Colitis

Keywords

golimumab; drug monitoring; home based care

Outcome Measures

Primary Outcomes (1)

• Comparison of golimumab serum sample through venous puncture and dried blood spot analysis

  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

Secondary Outcomes (10)

• Area under the curve of golimumab exposure during induction therapy

  1.5 months

• Area under the curve of golimumab exposure during maintenance therapy

  3.0 months

• Maximum golimumab serum concentration during induction therapy

  1.5 months

• Maximum golimumab serum concentration during maintenance therapy

  3.0 months

• Patient perception question 1: The information I received from my physician and colleagues regarding dried blood spot analyses was adequate

  After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy

Study Arms (2)

Cohort A

OTHER

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)

Other: Cohort A

Cohort B

OTHER

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)

Other: Cohort B

Interventions

Cohort A OTHER

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)

Also known as: Monitoring through serum and dry blood spot analysis

Cohort A

Cohort B OTHER

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)

Also known as: Monitoring through serum and dry blood spot analysis

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• General Hospital Groeninge: collaborator

Study Sites (2)

AZ Groeninge

Belgium, Kortrijk, 8500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Detrez I, Schops G, Lefrere J, Tops S, Van Assche G, Vermeire S, Van Moerkercke W, Ferrante M, Gils A. Golimumab Dried Blood Spot Analysis (GOUDA): a Prospective Trial Showing Excellent Correlation with Venepuncture Samples and More Detailed Pharmacokinetic Information. AAPS J. 2018 Dec 18;21(1):10. doi: 10.1208/s12248-018-0282-x.

  PMID: 30564993 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Marc Ferrante, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 22, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)