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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004354-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
| The Danish Rheumatism Association | OTHER |
| The Danish Psoriasis Association | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 3b (non-intervention) | No Intervention | Observation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast Oral Tablet | Drug | As in description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in DAS28-CRP (Disease Activity Score, 28 joints, CRP) from baseline to month 3 and 6, and from month 6 to month 12. | Part 3 | 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. |
Inclusion Criteria:
In general (all parts of the study):
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:
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))
Exclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup | Glostrup Municipality | 2600 | Denmark | |||
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
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| ID | Term |
|---|---|
| C505730 | apremilast |
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As described. Only part 3 of the study is considered interventional.
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Part 2 |
| Day 0 |
| The prevalence of US defined enthesitis at the individual 12 entheseal sites in patients with compared to patients without musculoskeletal pain. | Part 2 | 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). | Part 2 | Day 0 |
| Sensitivity and specificity of screening questionnaires, with fulfillment of CASPAR criteria as gold standard, and "US defined PsA" as alternative. | Part 2 | Day 0 |
| 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 | 3, 6, 12 months |
| 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 | 0-6 months, 6-12 months |
| 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 | 0-3-6-12 months |
| 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 | 0-3-6-12 months |
| Change in PRO's (including PsAID, HAQ) from baseline to 3, 6, 9 and 12 months. | Part 3 | 0-3-6-9-12 months |
| 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 | 0-3-6-12 months |
Part 3 |
| 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. | Part 3 | 0-3-6-12 months |
| Change in mCPDAI (modified Composite Psoriatic Disease Activity Index) from baseline to month 3 and 6, and from month 6 to month 12. | Part 3 | 0-3-6-12 months |
| Evaluation of EULAR response criteria from baseline to month 3 and 6, and from month 6 to month 12. | Part 3 | 0-3-6-12 months |
| Evaluation of ACR (American College of Rheumatology) response criteria from baseline to month 3 and 6, and from month 6 to month 12. | Part 3 | 0-3-6-12 months |
| Evaluation of PsARC (Psoriatic Arthritis Response Criteria) from baseline to month 3 and 6, and from month 6 to month 12. | Part 3 | 0-3-6-12 months |
| Dansk Gigthospital |
| Sønderborg |
| 6400 |
| Denmark |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |