PsoriasisPhase 4NCT02602925
Tight Control Dose Reductions of Biologics in Psoriasis Patients With Low Disease Activity
A Phase 4 study testing Dose decrease in people with Psoriasis, run by Radboud University Medical Center at 6 sites in Netherlands.
Trial summary
Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics. Objective To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease. Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with cost-effectiveness analysis. 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 decrease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesNetherlands
- Study dates
- Mar 2016to 20 Jul 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
- Sustained low disease activity as described above on the dose as advised by the label.
- Established diagnosis of plaque psoriasis.
- Receiving treatment with adalimumab, etanercept, or ustekinumab for at least 6 months.*
- Age ≥18 years.
- Ability to understand informed consent, read and answer questionnaires.
Who cannot join
- Psoriasis itself is not the main reason for biologic prescription (e.g. when a patient has RA and psoriasis, and RA is the main reason for the biologic).
- Concomitant use of immunosuppressants other than methotrexate or acitretin for psoriasis.
- Severe comorbidities with short life-expectancy (e.g. metastasized tumour).
- Presumed inability to follow the study protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
ZGT hospital
Almelo
Gelre hospitals
Apeldoorn
Slingeland Hospital
Doetinchem
St. Anna hospital
Geldrop
ZGT
Hengelo
Radboudumc, dept of dermatology
Nijmegen
About this study
Official title: Tight Control Dose Reductions of Biologics in Psoriasis Patients With Low Disease Activity: A Randomized Pragmatic Trial
Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics.
Objective To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease.
Read more
Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with cost-effectiveness analysis.
Study population: Patients with disease remission using normal dose of biologics.
Intervention: 120 patients will be randomized into two groups: (1) dose reduction and (2) normal dose.
Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary outcomes are: health-related quality of life (HRQoL), number and time to disease flares, costs, health status, anti-drug antibody formation and serious adverse events
Read the detailed description
Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics. These drugs have significantly improved the quality of life of psoriasis patients, but are very expensive drugs that should be used as efficiently as possible. In addition, the long-term safety profile can probably be improved if patients receive the lowest effective dose.
Objective To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease: Is dose reduction non-inferior to the current practice regarding clinical effectiveness? Secondary aims are: to investigate what influence dose tapering has on quality of life, whether there are predictors for successful dose reduction, and to determine the cost-effectiveness of dose reduction.
Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with cost-effectiveness analysis.
Study population: Patients who used a biologic for at least 6 months (etanercept, adalimumab, ustekinumab) can be included if they have long-term stable low disease activity. Low disease activity is defined as a PASI score (Psoriasis Area and Activity Score) <5 and a health-related quality of life score ≤5 (Dermatology Quality of life index: DLQI).
Intervention: 120 patients will be randomized into two groups: (1) dose reduction guided by PASI and DLQI (n=60, intervention) and (2) maintenance of normal dosage (n=60, usual care).
Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary outcomes are: health-related quality of life (HRQoL), number and time to disease flares, costs, health status, anti-drug antibody formation and serious adverse events
- Conditions
- Psoriasis
- Being tested
- Dose decrease, Usual care
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose decreaseOther
Treatment strategy change: dose decrease based on PASI and DLQI
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Dose decrease | Experimental | Patients receive daily practice care, but doses of etanercept, adalimumab or ustekinumab will be lowered: intervals of drug-administration will be prolonged stepwise with tight control of disease activity and DLQI. First, the dose will be decreased to 66-70% of the normal dose (by interval prolongation with a factor 1.5). If patients remain in a state of low disease activity, the dose will be further reduced to 50% (by doubling the original interval). Each step will be analyzed after three months, or when the patient visits earlier due to complaints. Receives: Other: Dose decrease |
| Usual care | Other | Patients will continue treatment with the normal dose and treatment regimens will be based on usual daily practice care. Treatment decisions are made at the discretion of the treating physician. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-activity
Disease-activity measured by Psoriasis Area and Severity Index (PASI), effectiveness measure used in most psoriasis trials.
Measured: 1 year
Secondary outcomes (10)
Health-related quality of life (HRQoL-DLQI)
HRQoL(Dermatology Life Quality Index (DLQI)
Measured: 1 year
Number of patients with 1 or more persistent flares
Number of patients with 1 or more persistent flares (persistent flare is defined as at least 3 months PASI increase >5 or DLQI >5)
Measured: 1 year
Disease-activity measured with HsCRP
High-sensitivity CRP, a possible marker for disease-activity
Measured: 1 year
Predictors for succesful dose decrease (treatment and patient characteristics)
For both groups, patient (sex, age, PsA, comorbidities) and treatment characteristics (antibody formation, through levels of drug, dose of biologic, drug pauses, use of concomitant antipsoriatic systemic drugs (dose and duration of use), use of topical therapies during treatment (steroid class and duration of use)) will be collected. These will be used to identify predictors for successful dose reduction.
Measured: 1 year
Anti-drug antibody levels against etanercept, adalimumab or ustekinumab
Anti-drug antibodies (AU/mL) of the used biologic (etanercept, adalimumab or ustekinumab) will be measured using enzyme-linked immunosorbent assay or ELISA. Measures will take place at baseline and every study visit (week 0, 12, 24, 36 and 49). Anti-drug antibody levels will be used to assess whether they predict successful dose decrease.
Measured: 1 year
Drug trough levels of etanercept, adalimumab or ustekinumab
Drug trough levels (mg/l) of the used biologic (etanercept, adalimumab or ustekinumab) will be measured using enzyme-linked immunosorbent assay or ELISA. Measures will take place at baseline and every study visit (aprox. every 3 months). Anti-drug antibody levels will be used to assess whether they predict successful dose decrease.
Measured: 1 year
Number of serious adverse events per patient
All serious adverse events (SAE) during study participation and their causal relation with the biologic will be assessed.
Measured: 1 year
Costs related to medical consumption
For cost-effectiveness analyses, questionnaires iMTA MCQ (medical consumption questionnaire) will be administered in each group at every study visit except baseline (week 12, 24, 36, 49).Data will be incorporated and presented in a cost-effectiveness analysis.
Measured: 1 year
Costs related to productivity
For cost-effectiveness analyses, questionnaire iMTA PCQ (productivity cost questionnaire) will be administered in each group at every study visit except baseline (week 12, 24, 36, 49).Data will be incorporated and presented in a cost-effectiveness analysis.
Measured: 1 year
Health status (SF36)
SF-36v2 questionnaire will be used to measure health status. Outcomes will be presented seperataly (scores for mental and physical health domain); but will also be incorporated and presented in a cost-effectiveness analysis. Questionnaire will be administered every study visit except baseline (week 12, 24, 36, 49).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startMar 2016
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Randomized, controlled non-inferiority study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- E de Jong, MD, Principal investigator, Dept. of Dermatology, Radboudumc, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602925
- Sponsor's protocol ID
- CONDOR
- Status last verified
- Nov 2016
- First submitted
- 9 Oct 2015
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Atalay S, van den Reek JMPA, den Broeder AA, van Vugt LJ, Otero ME, Njoo MD, Mommers JM, Ossenkoppele PM, Koetsier MI, Berends MA, van de Kerkhof PCM, Groenewoud HMM, Kievit W, de Jong EMGJ. Comparison of Tightly Controlled Dose Reduction of Biologics With Usual Care for Patients With Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Apr 1;156(4):393-400. doi: 10.1001/jamadermatol.2019.4897.
PubMed 32049319Atalay S, van den Reek JMPA, van Vugt LJ, Otero ME, van de Kerkhof PCM, den Broeder AA, Kievit W, de Jong EMGJ. Tight controlled dose reduction of biologics in psoriasis patients with low disease activity: a randomized pragmatic non-inferiority trial. BMC Dermatol. 2017 May 8;17(1):6. doi: 10.1186/s12895-017-0057-6.
PubMed 28482858
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Control Dose Reductions of Biologics in Psoriasis Patients With Low Disease Activity: A Randomized Pragmatic Trial
- ClinicalTrials.gov ID
- NCT02602925
- Acronym / sponsor ID
- CONDOR
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Mar 2016 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 11 Nov 2015 (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.
Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics.
Objective To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease.
Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with cost-effectiveness analysis.
Study population: Patients with disease remission using normal dose of biologics.
Intervention: 120 patients will be randomized into two groups: (1) dose reduction and (2) normal dose.
Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary outcomes are: health-related quality of life (HRQoL), number and time to disease flares, costs, health status, anti-drug antibody formation and serious adverse events
Detailed description
Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics. These drugs have significantly improved the quality of life of psoriasis patients, but are very expensive drugs that should be used as efficiently as possible. In addition, the long-term safety profile can probably be improved if patients receive the lowest effective dose.
Objective To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease: Is dose reduction non-inferior to the current practice regarding clinical effectiveness? Secondary aims are: to investigate what influence dose tapering has on quality of life, whether there are predictors for successful dose reduction, and to determine the cost-effectiveness of dose reduction.
Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with cost-effectiveness analysis.
Study population: Patients who used a biologic for at least 6 months (etanercept, adalimumab, ustekinumab) can be included if they have long-term stable low disease activity. Low disease activity is defined as a PASI score (Psoriasis Area and Activity Score) <5 and a health-related quality of life score ≤5 (Dermatology Quality of life index: DLQI).
Intervention: 120 patients will be randomized into two groups: (1) dose reduction guided by PASI and DLQI (n=60, intervention) and (2) maintenance of normal dosage (n=60, usual care).
Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary outcomes are: health-related quality of life (HRQoL), number and time to disease flares, costs, health status, anti-drug antibody formation and serious adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Dose decrease | Experimental | Other: Dose decreasePatients receive daily practice care, but doses of etanercept, adalimumab or ustekinumab will be lowered: intervals of drug-administration will be prolonged stepwise with tight control of disease activity and DLQI. First, the dose will be decreased to 66-70% of the normal dose (by interval prolongation with a factor 1.5). If patients remain in a state of low disease activity, the dose will be further reduced to 50% (by doubling the original interval). Each step will be analyzed after three months, or when the patient visits earlier due to complaints. |
| Usual care | Other | Other: Usual carePatients will continue treatment with the normal dose and treatment regimens will be based on usual daily practice care. Treatment decisions are made at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sustained low disease activity as described above on the dose as advised by the label.
- Established diagnosis of plaque psoriasis.
- Receiving treatment with adalimumab, etanercept, or ustekinumab for at least 6 months.*
- Age ≥18 years.
- Ability to understand informed consent, read and answer questionnaires.
Key exclusion criteria (4 listed)
- Psoriasis itself is not the main reason for biologic prescription (e.g. when a patient has RA and psoriasis, and RA is the main reason for the biologic).
- Concomitant use of immunosuppressants other than methotrexate or acitretin for psoriasis.
- Severe comorbidities with short life-expectancy (e.g. metastasized tumour).
- Presumed inability to follow the study protocol.
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 decreaseTreatment strategy change: dose decrease based on PASI and DLQI | Other | Dose decrease |
| Usual careUsual care | Other | Usual care |
Primary outcome
Disease-activity
Time frame: 1 year
Disease-activity measured by Psoriasis Area and Severity Index (PASI), effectiveness measure used in most psoriasis trials.
10 secondary outcomes
Health-related quality of life (HRQoL-DLQI)
Time frame: 1 year
Number of patients with 1 or more persistent flares
Time frame: 1 year
Disease-activity measured with HsCRP
Time frame: 1 year
Predictors for succesful dose decrease (treatment and patient characteristics)
Time frame: 1 year
Anti-drug antibody levels against etanercept, adalimumab or ustekinumab
Time frame: 1 year
Drug trough levels of etanercept, adalimumab or ustekinumab
Time frame: 1 year
Number of serious adverse events per patient
Time frame: 1 year
Costs related to medical consumption
Time frame: 1 year
Costs related to productivity
Time frame: 1 year
Health status (SF36)
Time frame: 1 year
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 1 Apr 2019.
- Derived from this study: PubMed 32049319Atalay S, van den Reek JMPA, den Broeder AA, van Vugt LJ, Otero ME, Njoo MD, Mommers JM, Ossenkoppele PM, Koetsier MI, Berends MA, van de Kerkhof PCM, Groenewoud HMM, Kievit W, de Jong EMGJ. Comparison of Tightly Controlled Dose Reduction of Biologics With Usual Care for Patients With Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Apr 1;156(4):393-400. doi: 10.1001/jamadermatol.2019.4897.
- Derived from this study: PubMed 28482858Atalay S, van den Reek JMPA, van Vugt LJ, Otero ME, van de Kerkhof PCM, den Broeder AA, Kievit W, de Jong EMGJ. Tight controlled dose reduction of biologics in psoriasis patients with low disease activity: a randomized pragmatic non-inferiority trial. BMC Dermatol. 2017 May 8;17(1):6. doi: 10.1186/s12895-017-0057-6.
- Individual participant dataSharing planned: Undecided
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
E de Jong, MD principal investigator
Dept. of Dermatology, Radboudumc, The Netherlands
6 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 Dose decrease in people with Psoriasis, run by Radboud University Medical Center at 6 sites in Netherlands.
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 5 inclusion and 4 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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?
Disease-activity (time frame: 1 year). 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 NCT02602925, which also lists 2 linked publications.
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 1 Apr 2019.