Assessment of the Clinical and Ultrasound Response to Apremilast by Clinical Evaluation and by a Joint-periarticular-nail Ultrasound Index in Patients With Active Psoriatic Arthritis

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT03191539
Phase
PHASE3
Status
Unknown

Conditions

  • Arthritis; Psoriasis (Etiology)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    30 mg twice a day during 52 weeks. In the first 6 days will be a dose escalation

Study Details

This study aims to evaluate more objectively, through an imaging technique such as ultrasound, changes in joints and entheses of patients with active psoriatic arthritis (PAs) who will start treatment with Apremilast after the failure of other therapies such as synthetic DMARD (metrotrexato , Leflunomide ...). The hypothesis of the study is that the technique of ultrasound can demonstrate the efficacy of Apremilast in the treatment of patients with active PAs

Key Dates

First listed
Jun 19, 2017
Start date
Nov 2, 2017
Status verified
Jun 2017
Primary completion
Jun 14, 2019
Completion
Jun 14, 2019

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    30 mg of Apremilast twice a day during 52 weeks. During the first 6 days will be a dose escalation as the following: Day 1: 10 mg daily Day 2: 10 mg day- 10 mg night Day 3: 10 mg day- 20 mg night Day 4: 20mg day- 20mg night Day 5: 20 mg day- 30 mg night Day 6: 30 mg day- 30 mg night

Primary Outcome Measure

Reduction in the ultrasound index [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]

Central Contacts