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PsoriasisPhase 4DANPAPPNCT04515732

Danish Population-based Assessment of Psoriasis and Psoriatic Arthritis (DANPAPP)

A Phase 4 study testing Apremilast Oral Tablet in people with Psoriasis and Psoriatic Arthritis, run by Professor Mikkel Østergaard at 2 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

3-part study of patients with psoriasis, including 1) a population based questionnaire 2) cross-sectional clinical study with focus on musculoskeletal ultrasound and patient reported outcomes 3) 12 months follow-up study of patients with certain ultrasonic signs of psoriatic arthritis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis, Psoriatic Arthritis
What is being tested?
Apremilast Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
2 sitesDenmark
Study dates
14 Dec 2018to Oct 2021
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

  • In general (all parts of the study):
  • Age >18 years
  • Being able and willing to comply with the requirements of this protocol
  • Having signed informed consent
  • Part 2:
  • Psoriasis, diagnosed by a physician according to patient
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  • Part 3a:
  • Musculoskeletal pain in relation to joints or entheses (that is not explained by alternative diagnosis, as assessed by including rheumatologist) and"US-defined PsA" (ie. with certain joint and/or entheseal inflammation as documented by US (see 'Definitions of patient populations' for definition))
  • MRI substudy:
  • Clinical dactylitis or enthesitis in the ankle region (Achilles enthesitis or plantar fasciitis)
  • No contraindications for MRI (see appendix 22.2.2) For allowed and disallowed previous and concomitant treatment, please see paragraph on "Previous and concomitant medication".
  • Part 3b:
  • Not having musculoskeletal pain but still "US-defined PsA" (i.e. with certain joint and/or entheseal inflammation as documented by US (see 'Definitions of patient populations' for definition))

Who cannot join

  • In general (all parts of study):
  • Incapability of complying with the examination program of this protocol for physical, mental or practical reasons.
  • Part 2:
  • Incapability of understanding spoken or written danish.
  • Part 3a:
  • Pregnancy, pregnancy wish or breast-feeding.
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  • Hypersensitivity to the active substance (apremilast) or any of the excipients.
  • Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose
  • malabsorption
  • Severe renal failure (glomerular filtration rate (GFR) <30ml/min)
  • Current treatment with potent CYP3A4 enzyme inhibitors (rifampicin, phenobarbital, carbamazepin, phenytoin, perikon ("grønne lykkepiller" , Neurokan, Modigen, Calmigen, Velzina))
  • Current or planned (during the study period) treatment that might cause psychiatric symptoms
  • Known active tuberculosis (TB) or history of incompletely treated TB.
  • Clinical history of serious liver disease.
  • Hepatitis B antigen positivity or Hepatitis C antibodies positivity at screening (tests ≤3 months before inclusion is accepted).
  • Bacterial infections requiring antibiotics (oral or intravenously) or serious viral or fungal infections within the last four weeks before screening. Treatment of such infections should be completed 4 weeks prior to screening.
  • Clinical history of serious immunological disease (including HIV or other congenital or acquired immune disease) or other serious uncontrolled disease.
  • Current depression, previous depression, previous suicidal thoughts/tendencies or psychiatric symptoms
  • Conditions, including abnormal laboratory measurements, which might put the patient at an unnecessary risk by participation in the study or make data difficult to interpret.
  • Known inflammatory rheumatic disease other than PsA.
  • MRI substudy: Contraindications for MRI (see appendix 22.2.2)
  • Certain previous and concomitant treatment

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup

    Glostrup Municipality, 2600

  • Dansk Gigthospital

    Sønderborg, 6400

Other trials in Denmark

About this study

Official title: Prevalence, Pattern and Disease Course og Arthritis and Enthesitis in Patients With Psoriasis, and Effect of Apremilast in Subclinical, US-defined Psoriatic Arthritis - a Population Based Study Applying Clinical, Ultrasonic, MRI and Patient-reported Outcomes

3-part study of patients with psoriasis, including 1) a population based questionnaire 2) cross-sectional clinical study with focus on musculoskeletal ultrasound and patient reported outcomes 3) 12 months follow-up study of patients with certain ultrasonic signs of psoriatic arthritis. Patients with pain: Interventional with 6 months treatment with apremilast, followed by 6 months observation. Patients without pain: 12 months observation.

Read the detailed description

Part 1:

A population-based survey of Danish inhabitants, will by screening of approximately 10.000 Danes identify approximately 425 persons who report to have psoriasis(PsO) with or without psoriatic arthritis (PsA). These will receive an e-mail invitation to an internet based questionnaire regarding demographics, skin and joint complaints, diagnosed diseases, contact to health care providers, and different aspect of psychological and physical function and wellbeing (incl. function, health-related quality of life, depression, anxiety, social participation, and sleep disturbances). In the questionnaire the participant will be asked if he/she would be interested in participating in a clinical study.

Part 2:

Participants who accept the above mentioned invitation (estimated 273) will be seen in a Department of Rheumatology, for the following examination programme: Clinical examination with a focus on skin, joints and entheses,ultrasonic (US) examination of joints and entheses, patient-reported outcomes and blood sampling for both stratification and identification of biochemical signs of inflammation.

Patients with musculoskeletal pain and certain joint and/or entheseal inflammation documented by US, will be invited to participate in a 12 months' interventional study (part 3a, below), whereas patients without musculoskeletal pain but with US findings (as above) will be invited to participate in a 12 months non-interventional follow-up study (part 3b, below). Patients with pre-diagnosed PsA that by US have active inflammation (same definition and criteria as above), will also be invited to participate in the interventional study if they fit the criteria, especially those described under concomitant medication, otherwise they will be offered to participate in the non-interventional study.

Part 3a:

Patients with musculoskeletal pain in relation to joints and/or entheses (that is not explained by alternative diagnosis, as assessed by including rheumatologist) and "US-defined PsA", i.e. with certain joint and/or entheseal inflammation as documented by US, will be offered inclusion in a 12 months' interventional study, in which 6 month induction therapy with apremilast (in addition to their usual therapy) will be followed by cessation of apremilast and 6 months of observation. Patients will be followed with clinical examination, PRO's, blood sampling and US at months 3, 6, 9 and 12.

MRI will be performed at inclusion and at 6 months follow-up in selected patients (patients with dactylitis or with enthesitis in the ankle region (Achilles enthesitis or plantar fasciitis)).

Part 3b:

Patients without musculoskeletal pain but with certain joint or entheseal inflammation verified by US will be offered inclusion in a 12 months' non-interventional study. Patients will continue their current therapy and be followed with clinical examination, patient-reported outcomes, blood sampling and US at months 3, 6, 9 and 12.

Being tested
Apremilast Oral Tablet
Keywords
Ultrasound, Patient reported outcome measures
Medical subject headings
Psoriasis, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apremilast Oral TabletDrug

    As in description

Study groups in NCT04515732
Study groupRoleWhat they receive
3a (apremilast intervention)ExperimentalApremilast in standard dosis (gradual increase 0-30 mg x 2 daily over the first 6 days, hereafter 30 mg x 2 daily) for 6 months, followed by 6 months observation.
Receives: Drug: Apremilast Oral Tablet
3b (non-intervention)No interventionObservation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with PsO reporting musculoskeletal pain within the past 12 months

    Part 1 - e-based questionnaire. Number of patients reporting joint- or entheseal pain within the past 12 months

    Measured: 1 day (At completion of questionnaire (performed once))

  2. The difference in number of joints with US defined synovitis, in PsO patients with, compared to patients without musculoskeletal pain.

    Part 2 - cross sectional study

    Measured: Day 0

  3. The difference in number of entheses with US defined enthesitis, in PsO patients with, compared to patients without musculoskeletal pain.

    Part 2 - cross sectional study

    Measured: Day 0

  4. Change in OMERACT-EULAR Global US score of synovitis, from baseline to 6 months, in patients treated with apremilast (intervention group).

    Part 3 - follow up study

    Measured: 6 months

Secondary outcomes (11)

  1. The correlations between presence of musculoskeletal pain and patient reported outcomes of function, health related quality of life, and impact on patient's lives (including EQ5D, HAQ and PsAID)

    Part 1

    Measured: 1 day (At completion of e-based questionnaire (performed once))

  2. The prevalence of US defined synovitis at the individual 48 joints sites in patients with compared to patients without musculoskeletal pain.

    Part 2

    Measured: Day 0

  3. The prevalence of US defined enthesitis at the individual 12 entheseal sites in patients with compared to patients without musculoskeletal pain.

    Part 2

    Measured: Day 0

  4. The correlation between clinical and US scores of synovitis and enthesitis with patient reported outcomes of pain, function and impact on patient's lives (including pain, HAQ and PsAID).

    Part 2

    Measured: Day 0

  5. Sensitivity and specificity of screening questionnaires, with fulfillment of CASPAR criteria as gold standard, and "US defined PsA" as alternative.

    Part 2

    Measured: Day 0

  6. Change in "US total count of inflamed joints and entheses" from baseline to 3, 6 and 12 months, and from 6 to 12 months, in intervention and non-intervention groups.

    Part 3

    Measured: 3, 6, 12 months

  7. Change in patient global pain on a visual analogue scale (VAS, range 0-100), from baseline to 6 months and from 6 to 12 months in intervention group.

    Part 3

    Measured: 0-6 months, 6-12 months

  8. Change in OMERACT-EULAR Global US score of synovitis from baseline to 3 and 6 months, and from 6 to 12 months, in intervention and non-intervention groups.

    Part 3

    Measured: 0-3-6-12 months

  9. Change in US enthesitis activity score from baseline to 3, 6 and 12 months, and from 6 to 12 months, in intervention and non-intervention groups.

    Part 3

    Measured: 0-3-6-12 months

  10. Change in PRO's (including PsAID, HAQ) from baseline to 3, 6, 9 and 12 months.

    Part 3

    Measured: 0-3-6-9-12 months

  11. The correlation between changes in clinical and US scores of synovitis and enthesitis and changes in patient reported outcomes, overall and in intervention and non-intervention groups.

    Part 3

    Measured: 0-3-6-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2020
  2. Study start14 Dec 2018
  3. Primary completionApr 2021 (estimated)
  4. Study completionOct 2021 (estimated)

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
As described. Only part 3 of the study is considered interventional.
Masking
None (open label)
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04515732
Sponsor's protocol ID
DANPAPP
Other IDs
2016-004354-15, 2016
Acronym
DANPAPP
Status last verified
Aug 2020
First submitted
12 Dec 2018
Last updated
17 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apremilast Oral Tablet in people with Psoriasis and Psoriatic Arthritis, run by Professor Mikkel Østergaard at 2 sites in Denmark.

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 13 inclusion and 22 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 17 Aug 2020. 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 Denmark. 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?

Number of participants with PsO reporting musculoskeletal pain within the past 12 months (time frame: 1 day (At completion of questionnaire (performed once))). The study lists 4 primary outcomes in all. 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 NCT04515732.

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 17 Aug 2020.

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