The DIagnostic VAlue of Musculoskeletal UltraSound (MSUS) in the detection of Early signs ofpsoriatic arthritis - An open label, proof-of-concept study using Apremilast in a cohort of very earlypsoriatic arthritis in patients with ultrasound-enthesitis and arthralgia (The DIVAMUSE-study)

Phase 4

Conditions: Enthesitis
M07.0
M07.3
Distal interphalangeal psoriatic arthropathy
Other psoriatic arthropathies

Registration Number: DRKS00025563

Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Male or female, age = 18 years.
2. The diagnosis of psoriatic arthritis should be confirmed during and/or fulfilled at screening according to CASPAR classification criteria. Family history of psoriasis and/or personal history of dactylitis is not mandatory, but can be used in order to fulfill CASPAR classification criteria.
3. If the diagnosis of psoriatic arthritis as per CASPAR classification criteria is already fulfilled, diagnosis should be not older than 6 months, and the patients should have had an inadequate response or have been intolerant to a prior DMARD therapy (not more than two doses shall have been received). NSAIDs and fumaric acid as prior treatments are allowed.
4. Musculoskeletal symptom duration should not be longer than 12 months before screening.
5. Plaque psoriasis (history of and/or active disease) as confirmed by a dermatologist (biopsy encouraged, but not mandatory).
6. Nail psoriasis confirmed by a dermatologist; in doubtful cases, fungal infection should be ruled out. Active disease in at least one finger or toenail at both screening and baseline is required.
7. Presence of arthralgia (mechanical reason should be ruled out).
8. Active enthesitis confirmed by MSUS, and prevalent at both screening and baseline.
9. Negative for rheumatoid factor AND ACPA; ANA within normal range.
10. If patients are on NSAIDs, a stable dose shall be kept during 2 weeks before baseline. Moreover, patients are encouraged to maintain a stable NSAID-dose during the course of the study; in the case of a flare however, NSAIDS can be used as a rescue medication (please see section on rescue medication for details).

Exclusion Criteria

1.Unwillingness or incapacity of adherence to study protocol
2.Musculoskeletal symptom duration > 12 months before screening
3.Pregnant or breastfeeding WOCBP, or women that plan to become pregnant during the course of the study or up to 3 months thereafter; women or men unwilling to use adequate methods of contraception such as (but not limited to) hormonal implants or hormonal contraceptives.
4.Positivity of rheumatoid factor, or ACPA or elevated concentration of ANA.
5.Iritis / anterior uveitis currently or in the last 6 months before first dose of study drug.
6.Any joint or enthesial infiltration or operation during < 12 weeks before baseline or during the course of the study.
7.New NSAID initiated or dose change = 2 weeks before baseline.
8.Changes in dose of glucocorticosteroids or dosage > 10mg/d = 2 weeks before baseline.
9.Pre-treatment of psoriatic arthritis with PDE-4-inhibitors, JAK-inhibitors, or any fusion proteins, or biological or conventional DMARDs other than methotrexate.
10.Use of any investigational drug other than study medication.
11.Hypersensitivity to apremilast or one of the other ingredients of the film-coated tablet.
12.Any other rheumatologic or autoimmune disease such as, but not limited to, rheumatoid arthritis, other spondyloarthrites than PsA, IBD, connective tissue disease, or MS. Patients with Hashimoto’s disease are eligible if the patient is euthyroid; substitution of thyroid hormones is not prohibited, if required by the patient and prescribed by a physician according to local guidelines.
13.Patients with fibromyalgia or another pain syndrome.
14.Any other skin disease despite psoriasis aggravating or inhibiting proper clinical examination.
15.Any other nail disease than nail psoriasis aggravating or inhibiting proper clinical examination.
16.Active malignant disease or history of malignoma < 5 years before baseline (adequately treated cervical carcinoma, squamous cell carcinoma and basalioma are allowed).
17.History of or active depression or any other psychological illness, which places the participant at an incalculable risk while undergoing PDE-4 inhibitor treatment to the opinion of the investigator.
18.Patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity including 95% confidence intervals of MSUS in Power Doppler mode using a 4-graded score compared to clinical assessment of enthesitis at week 24

Secondary Outcome Measures