Tight Control Dose Reductions of Biologics in Psoriasis Patients With Low Disease Activity
1 other identifier
interventional
120
1 country
6
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2016
Typical duration for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2018
CompletedApril 1, 2019
November 1, 2016
2.4 years
October 9, 2015
March 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-activity
Disease-activity measured by Psoriasis Area and Severity Index (PASI), effectiveness measure used in most psoriasis trials.
1 year
Secondary Outcomes (10)
Health-related quality of life (HRQoL-DLQI)
1 year
Number of patients with 1 or more persistent flares
1 year
Disease-activity measured with HsCRP
1 year
Predictors for succesful dose decrease (treatment and patient characteristics)
1 year
Anti-drug antibody levels against etanercept, adalimumab or ustekinumab
1 year
- +5 more secondary outcomes
Study Arms (2)
Dose decrease
EXPERIMENTALPatients 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
OTHERPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
ZGT hospital
Almelo, Netherlands
Gelre hospitals
Apeldoorn, Netherlands
Slingeland Hospital
Doetinchem, Netherlands
St. Anna hospital
Geldrop, Netherlands
ZGT
Hengelo, Netherlands
Radboudumc, dept of dermatology
Nijmegen, Netherlands
Related Publications (2)
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.
PMID: 32049319DERIVEDAtalay 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.
PMID: 28482858DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
E de Jong, MD
Dept. of Dermatology, Radboudumc, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2015
First Posted
November 11, 2015
Study Start
March 1, 2016
Primary Completion
July 20, 2018
Study Completion
July 20, 2018
Last Updated
April 1, 2019
Record last verified: 2016-11