PsoriasisPhase 4NCT05683054
A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients Who Are Overtreated
A Phase 4 study testing Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels, Venapuncture and Dermatology Life Quality Index (DLQI) in people with Psoriasis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Recently, the optimal therapeutic serum trough level range of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab serum through level above this therapeutic range did not add to clinical response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels, Venapuncture and Dermatology Life Quality Index (DLQI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Aug 2020to 22 Aug 2022
- 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
- Participants must be >18 years of age.
- Participants must have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without PsA), prior to the first administration of study intervention.
- Participant must remain on a highly effective method of birth control during the study or during the entire treatment with adalimumab (whether with is longer)
- Participants are considered eligible according to the following TB screening criteria:
- Have no history of latent or active TB before screening
- Have no signs or symptoms suggestive for active TB upon medical history and/or physical examination
Show all 10Show fewer
- Have had no recent close contact with a person with active TB
- Participants must agree not to receive a live virus or live bacterial vaccination at least 3 months (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study intervention (except for varicella and MMR vaccines), during the study, or within 3 months after the last administration of study intervention.
- Participants must avoid prolonged sun exposure and use of tanning booths or other ultraviolet light sources during study.
- Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
Who cannot join
- Participants who have currently a predominant nonplaque forms of psoriasis (eg. Erythrodermic, guttate, pustular)
- Participants who are pregnant, nursing or planning a pregnancy or fathering a child while enrolled in the study or within 12 weeks after receiving the last administration of study intervention
- Participants who have received, or are expected to receive, any live virus or bacterial vaccination (with the exception of varicella or MMR vaccines) within 3 months (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study intervention, during the study, or within 12 weeks after the last administration of study intervention
- Participants who have known allergies, hypersensitivity or intolerance to adalimumab or its excipients
- Participants who have any malignancy or have a history of malignancy
- Participants who are unable or unwilling to undergo multiple venapunctures
Trial locations and contacts
1 site in 1 country.
About this study
Recently, the optimal therapeutic serum trough level range of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab serum through level above this therapeutic range did not add to clinical response. Based on this therapeutic window, the introduction of dose adjustments based on serum trough levels (therapeutic drug monitoring) will be further validated in a prospective controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab STLs, dose reduction based on therapeutic drug monitoring (TDM) is able to maintain the initial clinical outcome.
Read the detailed description
In this study we investigate whether dose reduction of adalimumab in patients with supratherapeutic adalimumab Ctrough levels is non-inferior to standard dosing of adalimumab.
Before randomization, 3 subsequent evaluations of adalimumab Ctroughs will be executed. Patients will be included after signing informed consent and randomized if 2/3 subsequent measurements during screening show supratherapeutic Ctrough levels. Time point of randomization is considered baseline (week 0). PASI calculation will be performed by a blinded and independent physician.
In the concentration based arm, dosing frequency will be lowered to 40 mg every 3 weeks (33% reduction). In case of persistent supratherapeutic Ctroughs, a 50% dose reduction will be applied from week 12 onwards. In the standard based arm, patients will continue on standard dosing schedule of 40 mg every other week.
During each study visit PASI and IGA score will be evaluated by an independent and blinded physician and adverse events, and concomitant medications will be evaluated by a member of the study team. Ctrough is quantified at each visit; and anti-drug antibodies concentrations only if subtherapeutic concentrations are observed. Patients complete the Dermatology Life Quality Index (DLQI) and EuroQol-5D-5L instrument at each visit.
In addition, in a subset of patients in each treatment arm, additional sampling will be collected by dried blood spot sampling in order to build a PK(PD) model for adalimumab,
- Conditions
- Psoriasis
- Being tested
- Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels, Venapuncture, Dermatology Life Quality Index (DLQI), EQ-5D-5L questionnaire, Dried blood spot sampling
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose tapering of adalimumab in patients with supratheurapeutic serum trough levelsBiological
In the dose tapering arm, adalimumab dosing frequency will be lowered to 40 mg every 3 weeks in patients who have supratherapeutic serum trough levels of adalimumab (33% reduction). If patients still have a good clinical response and supratherapeutic adalimumab serum trough levels, will be further tapered to a dose regimen of 1 subcutaneous injection (40mg) every 4 weeks (50% dose reduction).
VenapunctureProcedure or surgery
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of adalimumab
Dermatology Life Quality Index (DLQI)Other
The impact of the disease on the patient will be assessed using the dermatology life quality index (DLQI).
EQ-5D-5L questionnaireOther
The EQ-5D-5L which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments will be assessed.
Dried blood spot samplingProcedure or surgery
A subset of patients will sample additionally by using dried blood sampling after the first drug injection post-inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Standard dosing group | Active comparator | In the standard based arm, patients will continue to receive adalimumab according to the standard dosing schedule of 40 mg every other week (maintenance phase). Receives: Procedure: Venapuncture; Other: Dermatology Life Quality Index (DLQI); Other: EQ-5D-5L questionnaire; Procedure: Dried blood spot sampling |
| Dose tapering group | Active comparator | In the dose tapering arm, adalimumab dosing frequency will be lowered to 40 mg every 3 weeks in patients who have supratherapeutic serum trough levels of adalimumab at three consecutive measurements. Receives: Biological: Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels; Procedure: Venapuncture; Other: Dermatology Life Quality Index (DLQI); Other: EQ-5D-5L questionnaire; Procedure: Dried blood spot sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
The proportion of patients in each group in clinical remission (absolute PASI < 2) at year 1 after optimization
Measured: 1 year after inclusion
Validation of adalimumab dried blood spots
Optimization of extraction protocol for adalimumab serum trough levels and anti-adalimumab antibody concentrations derived from dried blood spots (DBS)
Measured: Sampling at home on days 0, 3, 5, 7, 14, 21, 28, 35, 42 and 49 after adalimumab administration
Secondary outcomes (6)
Relapse
The proportion of patients in each group who relapse (defined as the need for dose escalation (not in the standard based dosing arm))
Measured: 1 year after inclusion
Serum trough levels of adalimumab within the optimal therapeutic window
The proportion of patients in each group with serum trough levels (STL) of adalimumab within the optimal interval (3.5µg/ml -7 µg/ml)
Measured: 1 year after inclusion
Anti- drug antibodies against adalimumab
The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab (ADA positivity)
Measured: 1 year after inclusion
Cost-effectiveness of adalimumab dose tapering
Measured: 1 year after inclusion
Quality adjusted life years
Measured: 1 year after inclusion
Identify relevant parameters for PK-PD modeling
- Recording of demographic parameters during disease course monitored at baseline and at every visit (reflected by incidence, prevalence, mortality, standardized comorbidity incidence ratios and associations/risk factors).
Measured: 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start11 Aug 2020
- Primary completion22 Mar 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, single blinded, randomized, non-inferiority study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Jo Lambert, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683054
- Sponsor's protocol ID
- TDM-ADA2019
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients Who Are Overtreated
- ClinicalTrials.gov ID
- NCT05683054
- Acronym / sponsor ID
- TDM-ADA2019
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 12 Jan 2023 (actual)
- 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.
Recently, the optimal therapeutic serum trough level range of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab serum through level above this therapeutic range did not add to clinical response. Based on this therapeutic window, the introduction of dose adjustments based on serum trough levels (therapeutic drug monitoring) will be further validated in a prospective controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab STLs, dose reduction based on therapeutic drug monitoring (TDM) is able to maintain the initial clinical outcome.
Detailed description
In this study we investigate whether dose reduction of adalimumab in patients with supratherapeutic adalimumab Ctrough levels is non-inferior to standard dosing of adalimumab.
Before randomization, 3 subsequent evaluations of adalimumab Ctroughs will be executed. Patients will be included after signing informed consent and randomized if 2/3 subsequent measurements during screening show supratherapeutic Ctrough levels. Time point of randomization is considered baseline (week 0). PASI calculation will be performed by a blinded and independent physician.
In the concentration based arm, dosing frequency will be lowered to 40 mg every 3 weeks (33% reduction). In case of persistent supratherapeutic Ctroughs, a 50% dose reduction will be applied from week 12 onwards. In the standard based arm, patients will continue on standard dosing schedule of 40 mg every other week.
During each study visit PASI and IGA score will be evaluated by an independent and blinded physician and adverse events, and concomitant medications will be evaluated by a member of the study team. Ctrough is quantified at each visit; and anti-drug antibodies concentrations only if subtherapeutic concentrations are observed. Patients complete the Dermatology Life Quality Index (DLQI) and EuroQol-5D-5L instrument at each visit.
In addition, in a subset of patients in each treatment arm, additional sampling will be collected by dried blood spot sampling in order to build a PK(PD) model for adalimumab,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, single blinded, randomized, non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Standard dosing group | Active comparator | Procedure: Venapuncture, Other: Dermatology Life Quality Index (DLQI), Other: EQ-5D-5L questionnaire, Procedure: Dried blood spot samplingIn the standard based arm, patients will continue to receive adalimumab according to the standard dosing schedule of 40 mg every other week (maintenance phase). |
| Dose tapering group | Active comparator | Biological: Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels, Procedure: Venapuncture, Other: Dermatology Life Quality Index (DLQI), Other: EQ-5D-5L questionnaire, Procedure: Dried blood spot samplingIn the dose tapering arm, adalimumab dosing frequency will be lowered to 40 mg every 3 weeks in patients who have supratherapeutic serum trough levels of adalimumab at three consecutive measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must be >18 years of age.
- Participants must have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without PsA), prior to the first administration of study intervention.
- Participant must remain on a highly effective method of birth control during the study or during the entire treatment with adalimumab (whether with is longer)
- Participants are considered eligible according to the following TB screening criteria:
- Participants must agree not to receive a live virus or live bacterial vaccination at least 3 months (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study intervention (except for varicella and MMR vaccines), during the study, or within 3 months after the last administration of study intervention.
Key exclusion criteria (6 listed)
- Participants who have currently a predominant nonplaque forms of psoriasis (eg. Erythrodermic, guttate, pustular)
- Participants who are pregnant, nursing or planning a pregnancy or fathering a child while enrolled in the study or within 12 weeks after receiving the last administration of study intervention
- Participants who have received, or are expected to receive, any live virus or bacterial vaccination (with the exception of varicella or MMR vaccines) within 3 months (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study intervention, during the study, or within 12 weeks after the last administration of study intervention
- Participants who have known allergies, hypersensitivity or intolerance to adalimumab or its excipients
- Participants who have any malignancy or have a history of malignancy
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 |
|---|---|---|
| Dose tapering of adalimumab in patients with supratheurapeutic serum trough levelsIn the dose tapering arm, adalimumab dosing frequency will be lowered to 40 mg every 3 weeks in patients who have supratherapeutic serum trough levels of adalimumab (33% reduction). If patients still have a good clinical response and supratherapeutic adalimumab serum trough levels, will be further tapered to a dose regimen of 1 subcutaneous injection (40mg) every 4 weeks (50% dose reduction). | Biological | Dose tapering group |
| VenapunctureBlood samples will be collected to determine the serum trough levels and anti-drug antibodies of adalimumab | Procedure or surgery | Dose tapering group, Standard dosing group |
| Dermatology Life Quality Index (DLQI)The impact of the disease on the patient will be assessed using the dermatology life quality index (DLQI). | Other | Dose tapering group, Standard dosing group |
| EQ-5D-5L questionnaireThe EQ-5D-5L which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments will be assessed. | Other | Dose tapering group, Standard dosing group |
| Dried blood spot samplingA subset of patients will sample additionally by using dried blood sampling after the first drug injection post-inclusion. | Procedure or surgery | Dose tapering group, Standard dosing group |
Primary outcome
Clinical response
Time frame: 1 year after inclusion
The proportion of patients in each group in clinical remission (absolute PASI < 2) at year 1 after optimization
Validation of adalimumab dried blood spots
Time frame: Sampling at home on days 0, 3, 5, 7, 14, 21, 28, 35, 42 and 49 after adalimumab administration
Optimization of extraction protocol for adalimumab serum trough levels and anti-adalimumab antibody concentrations derived from dried blood spots (DBS)
6 secondary outcomes
Relapse
Time frame: 1 year after inclusion
Serum trough levels of adalimumab within the optimal therapeutic window
Time frame: 1 year after inclusion
Anti- drug antibodies against adalimumab
Time frame: 1 year after inclusion
Cost-effectiveness of adalimumab dose tapering
Time frame: 1 year after inclusion
Quality adjusted life years
Time frame: 1 year after inclusion
Identify relevant parameters for PK-PD modeling
Time frame: 1 year after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- 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.
Jo Lambert, Prof. Dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels, Venapuncture and Dermatology Life Quality Index (DLQI) in people with Psoriasis, run by University Hospital, Ghent at 1 site 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical response (time frame: 1 year after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2023.