PsoriasisNCT02147600
Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients
An observational study of Psoriasis, run by University Hospital, Ghent at 5 sites in Belgium.
Trial summary
The main goal of this study is to determine optimal cut-off values of adalimumab trough levels corresponding to good clinical response. Determination of these values is necessary to compose a therapeutic algorithm, in which the dosing schedule can be adjusted according to serum trough levels of adalimumab and AAA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- Type of treatment
- Injection or infusion
- How many people
- 82 participants
- Where
- 5 sitesBelgium
- Study dates
- 9 Jan 2014to 10 Apr 2014
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: * Primary care clinic * University Hospital * Private dermatology practice
Who may be able to join
- minimum age 18 years old
- chronic plaque psoriasis
- adalimumab (40mg) subcutaneously every other week
- at least 24 weeks of adalimumab treatment
Who cannot join
- interruption of treatment schedule during 24 weeks prior to sampling
- adalimumab for other inflammatory disease and later developed psoriasis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Ghent University, Dpt. of Dermatology
Ghent, 9000
Maria Middelares Hospital
Ghent, 9000
St. Lucas Hospital
Ghent, 9000
H Hart Hospital
Mol, 2400
ST Rembert Hospital
Torhout, 8820
About this study
The main goal of this study is to determine optimal cut-off values of adalimumab trough levels corresponding to good clinical response. Determination of these values is necessary to compose a therapeutic algorithm, in which the dosing schedule can be adjusted according to serum trough levels of adalimumab and AAA (anti-adalimumab antibodies). A secondary objective of this study is to further detect and quantify AAA and to correlate them with adalimumab and clinical response in a real life setting cohort of psoriatic patients.
Read the detailed description
In a multicenter cross-sectional study, 73 adult patients treated with adalimumab (40 mg) every other week for at least 24 weeks are assessed for psoriasis disease severity through measurement of the Psoriasis Area and Severity Index (PASI) before adalimumab treatment start, and prior to sampling. Patients who interrupted their treatment schedule during the 24 weeks prior to blood sampling are excluded. Samples of patients who were treated with adalimumab for any other inflammatory disease and later developed psoriasis are also excluded. Percentage of PASI improvement compared to baseline (∆PASI) represents clinical response. Patients are classified as nonresponders (∆PASI<50), moderate responders (∆PASI 50-75) or good responders (∆PASI 75-100).Serum is collected for adalimumab trough level and anti-drug antibody determination (Sanquin, The Netherlands). By receiver-operator characteristics (ROC) analysis, a cut-off value of adalimumab trough level can be determined to distinguish insufficient from adequate responders.
- Conditions
- Psoriasis
- Keywords
- adalimumab, biologicals, immunogenicity
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic plaque psoriasis | Patients suffering from chronic plaque psoriasis, treated with adalimumab (40mg) subcutaneously every other week after an initial dose of 80 mg. Treatment duration of at least 24 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
75% improvement in clinical response
Minimum of 75 % PASI improvement compared to baseline (∆PASI 75) represents 75% improvement in clinical response.
Measured: at least 24 weeks of treatment duration
Secondary outcomes (1)
anti-adalimumab antibody formation
Measured: at least 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study start9 Jan 2014
- Primary completion10 Apr 2014
- Study completion10 Apr 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jo Lambert, Prof.Dr., Study director, Ghent University, Dpt. of DermatologyEmma Coussens, Principal investigator, Ghent University, Dpt. of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147600
- Sponsor's protocol ID
- EC UZG 2013/1148
- Status last verified
- Dec 2022
- First submitted
- 21 May 2014
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients
- ClinicalTrials.gov ID
- NCT02147600
- Acronym / sponsor ID
- EC UZG 2013/1148
- Conditions
- Psoriasis
- Keywords
- adalimumab, biologicals, immunogenicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 9 Jan 2014 (actual)
- Primary completion
- 10 Apr 2014 (actual)
- Study completion
- 10 Apr 2014 (actual)
- First posted
- 28 May 2014 (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.
The main goal of this study is to determine optimal cut-off values of adalimumab trough levels corresponding to good clinical response. Determination of these values is necessary to compose a therapeutic algorithm, in which the dosing schedule can be adjusted according to serum trough levels of adalimumab and AAA (anti-adalimumab antibodies). A secondary objective of this study is to further detect and quantify AAA and to correlate them with adalimumab and clinical response in a real life setting cohort of psoriatic patients.
Detailed description
In a multicenter cross-sectional study, 73 adult patients treated with adalimumab (40 mg) every other week for at least 24 weeks are assessed for psoriasis disease severity through measurement of the Psoriasis Area and Severity Index (PASI) before adalimumab treatment start, and prior to sampling. Patients who interrupted their treatment schedule during the 24 weeks prior to blood sampling are excluded. Samples of patients who were treated with adalimumab for any other inflammatory disease and later developed psoriasis are also excluded. Percentage of PASI improvement compared to baseline (∆PASI) represents clinical response. Patients are classified as nonresponders (∆PASI<50), moderate responders (∆PASI 50-75) or good responders (∆PASI 75-100).Serum is collected for adalimumab trough level and anti-drug antibody determination (Sanquin, The Netherlands). By receiver-operator characteristics (ROC) analysis, a cut-off value of adalimumab trough level can be determined to distinguish insufficient from adequate responders.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic plaque psoriasis | – | –Patients suffering from chronic plaque psoriasis, treated with adalimumab (40mg) subcutaneously every other week after an initial dose of 80 mg. Treatment duration of at least 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Primary care clinic * University Hospital * Private dermatology practice
Key inclusion criteria (4 listed)
- minimum age 18 years old
- chronic plaque psoriasis
- adalimumab (40mg) subcutaneously every other week
- at least 24 weeks of adalimumab treatment
Key exclusion criteria (2 listed)
- interruption of treatment schedule during 24 weeks prior to sampling
- adalimumab for other inflammatory disease and later developed psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
75% improvement in clinical response
Time frame: at least 24 weeks of treatment duration
Minimum of 75 % PASI improvement compared to baseline (∆PASI 75) represents 75% improvement in clinical response.
1 secondary outcome
anti-adalimumab antibody formation
Time frame: at least 24 weeks of treatment
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 23 Dec 2022.
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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. study director
Ghent University, Dpt. of Dermatology
Emma Coussens principal investigator
Ghent University, Dpt. of Dermatology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by University Hospital, Ghent at 5 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 4 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: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
75% improvement in clinical response (time frame: at least 24 weeks of treatment duration). 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 23 Dec 2022.