A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults with Psoriatic ArthritisMOSAIC
Study Details
This study is designed to assess the efficacy of apremilast, either in monotherapy or with stable methotrexate, on imaging outcomes in adults with active psoriatic arthritis with less than 5 years of disease duration (since diagnosis), and who are naïve to biologic therapies.
Protocol Summary
Change from baseline in the composite score of BME, synovitis, and tenosynovitis assessed by Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS)
Timeframe: 24 weeks
Change from baseline in the composite score of BME, synovitis, and tenosynovitis assessed by PsAMRIS
Timeframe: 48 weeks
Change from baseline in the composite score of BME and synovitis assessed by PsAMRIS
Timeframe: 24 and 48 weeks
Change from baseline in the PsAMRIS total inflammation score
Timeframe: 24 and 48 weeks
Change from baseline in BME assessed by PsAMRIS
Timeframe: 24 and 48 weeks
Change from baseline in synovitis assessed by PsAMRIS
Timeframe: 24 and 48 weeks
Change from baseline in tenosynovitis assessed by PsAMRIS
Timeframe: 24 and 48 weeks
Change from baseline in periarticular inflammation assessed by PsAMRIS
Timeframe: 24 and 48 weeks
Change from baseline in the PsAMRIS total damage score
Timeframe: 24 and 48 weeks
Change from baseline in bone erosion assessed by PsAMRIS
Timeframe: 24 and 48 weeks
Change from baseline in bone proliferation/enthesophytes assessed by PsAMRIS
Timeframe: 24 and 48 weeks
Swollen Joint Count (SJC)
Timeframe: 24 and 48 weeks
Tender Joint Count (TJC)
Timeframe: 24 and 48 weeks
Change from baseline in the Clinical Disease Activity Index for Psoriatic Arthritis (c-DAPSA) Score
Timeframe: 24 and 48 weeks
Change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC), in subjects with preexisting enthesopathy
Timeframe: 24 and 48 weeks
Change from baseline in the Leeds Enthesitis Index (LEI), in subjects with preexisting enthesopathy
Timeframe: 24 and 48 weeks
Proportion of subjects with baseline enthesitis whose enthesitis improves to 0
Timeframe: 24 and 48 weeks
Change from baseline in the LDI, in subjects with preexisting dactylitis
Timeframe: 24 and 48 weeks
Proportion of subjects with baseline dactylitis whose dactylitis count improves to 0
Timeframe: 24 and 48 weeks
Change from baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS)
Timeframe: 24 and 48 weeks
Change from baseline in the Evaluator’s global assessment of disease activity
Timeframe: 24 and 48 weeks
Change from baseline in the Subject’s global assessment of disease activity
Timeframe: 24 and 48 weeks
Change from baseline in the Subject’s assessment of pain
Timeframe: 24 and 48 weeks
Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)
Timeframe: 24 and 48 weeks
Change from baseline in the WB-MRI Peripheral Enthesitis Inflammation Index
Timeframe: 24 and 48 weeks
Change from baseline in the WB-MRI Peripheral Joints Inflammation Index
Timeframe: 24 and 48 weeks
Change from baseline in the WB-MRI Total Peripheral Inflammation Index
Timeframe: 24 and 48 weeks
Change from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Timeframe: 24 and 48 weeks
Change from baseline in the Psoriatic Arthritis Impact of Disease 12 domains (PsAID-12)
Timeframe: 24 and 48 weeks
Adverse Events (AEs)
Timeframe: From enrollment until at least 28 days after completion of study treatment