Ulcerative ColitisPhase 4GOUDANCT02910375
Golimumab Dried Blood Spot Analysis
A Phase 4 study testing Cohort A and Cohort B in people with Ulcerative Colitis, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Cohort A and Cohort B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesBelgium
- Study dates
- Dec 2016to May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects with Crohn's disease, or IBD type unclassified
- Subjects who underwent a subtotal colectomy or proctocolectomy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Ulcerative Colitis
- Being tested
- Cohort A, Cohort B
- Keywords
- golimumab, drug monitoring, home based care
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort AOther
Also called Monitoring through serum and dry blood spot analysis
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)
Cohort BOther
Also called Monitoring through serum and dry blood spot analysis
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Cohort B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 1.5 months
Area under the curve of golimumab exposure during maintenance therapy
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
Measured: 3.0 months
Maximum golimumab serum concentration during induction therapy
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
Measured: 1.5 months
Maximum golimumab serum concentration during maintenance therapy
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
Measured: 3.0 months
Patient perception question 1: The information I received from my physician and colleagues regarding dried blood spot analyses was adequate
Score to check for adequate information. Possible answers: certainly not, no, I don't know, yes, for sure
Measured: 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
Score to check for accessibility for extra help. Possible answers: certainly not, no, I don't know, yes, for sure
Measured: 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.
Score to check for easiness of getting blood spot. Possible answers: certainly not, no, I don't know, yes, for sure
Measured: 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
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
Measured: 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
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
Measured: 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
Score to check for userfriendliness of dried blood spot analysis. Possible answers: certainly not, no, I don't know, yes, for sure
Measured: After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital Groeninge
- Responsible party
- Sponsor
- Investigators
- Marc Ferrante, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910375
- Sponsor's protocol ID
- S59372
- Acronym
- GOUDA
- Status last verified
- Oct 2017
- First submitted
- 12 Sep 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30564993
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-centric Belgian Trial to Validate the Use of Golimumab Serum Level Analysis Using the Dried Blood Spot (DBS) Methodology
- ClinicalTrials.gov ID
- NCT02910375
- Acronym / sponsor ID
- GOUDA / S59372
- Conditions
- Ulcerative Colitis
- Keywords
- golimumab, drug monitoring, home based care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- General Hospital Groeninge
- Study start
- Dec 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Other | Other: Cohort APatients 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) |
| Cohort B | Other | Other: Cohort BPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects with Crohn's disease, or IBD type unclassified
- Subjects who underwent a subtotal colectomy or proctocolectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort AAlso: Monitoring through serum and dry blood spot analysisVenous 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) | Other | Cohort A |
| Cohort BAlso: Monitoring through serum and dry blood spot analysisVenous 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) | Other | Cohort B |
Primary outcome
Comparison of golimumab serum sample through venous puncture and dried blood spot analysis
Time frame: 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
10 secondary outcomes
Area under the curve of golimumab exposure during induction therapy
Time frame: 1.5 months
Area under the curve of golimumab exposure during maintenance therapy
Time frame: 3.0 months
Maximum golimumab serum concentration during induction therapy
Time frame: 1.5 months
Maximum golimumab serum concentration during maintenance therapy
Time frame: 3.0 months
Patient perception question 1: The information I received from my physician and colleagues regarding dried blood spot analyses was adequate
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 30564993Detrez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Ferrante, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cohort A and Cohort B in people with Ulcerative Colitis, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of golimumab serum sample through venous puncture and dried blood spot analysis (time frame: During 4.5 months for golimumab starters and 3.0 months for patients under golimumab maintenance therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.