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

NCT04515732 | Unknown Phase 4 DMC

• 2 other identifiers: DANPAPP2016-004354-15
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

Brief 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. Patients with pain: Interventional with 6 months treatment with apremilast, followed by 6 months observation. Patients without pain: 12 months observation.

Conditions

Psoriasis; Psoriatic Arthritis

Keywords

Ultrasound; Patient reported outcome measures

Outcome Measures

Primary Outcomes (4)

• 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

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

• 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

  Day 0

• 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

  Day 0

• 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

  6 months

Secondary Outcomes (11)

• 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)

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

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

  Day 0

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

  Day 0

• 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).

  Day 0

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

  Day 0

Other Outcomes (7)

• Change in DAS28-CRP (Disease Activity Score, 28 joints, CRP) from baseline to month 3 and 6, and from month 6 to month 12.

  0-3-6-12 months

• Change in PASDAS (Psoriatic Arthritis Disease Activity Score) from baseline to month 3 and 6, and from month 6 to month 12.

  0-3-6-12 months

• Change in DAPSA (Disease Activity Index for Psoriatic Arthritis) from baseline to month 3 and 6, and from month 6 to month 12.

  0-3-6-12 months

Study Arms (2)

3a (apremilast intervention)

EXPERIMENTAL

Apremilast 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.

Drug: Apremilast Oral Tablet

3b (non-intervention)

NO INTERVENTION

Observation

Interventions

Apremilast Oral Tablet DRUG

As in description

3a (apremilast intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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))

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Professor Mikkel Østergaard: lead
• Celgene Corporation: collaborator
• The Danish Rheumatism Association: collaborator
• The Danish Psoriasis Association: collaborator

Study Sites (2)

Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

Dansk Gigthospital

Sønderborg, 6400, Denmark

Location

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, DMSc, PhD, MD

Model Details: As described. Only part 3 of the study is considered interventional.

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: August 17, 2020
• Study Start: December 14, 2018
• Primary Completion: April 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 17, 2020

Record last verified: 2020-08

Locations

DK (2)