Study Complete
Sponsor ID
CC-10004-PSA-014

A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults with Psoriatic ArthritisMOSAIC

Sponsor ID
CC-10004-PSA-014
Clinicaltrials.gov ID
NCT03783026
EUCTIS ID
N/A
EudraCT ID
2018-002748-10

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.

Additional Study Details

Phase
Phase 4
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
123
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from baseline in the composite score of BME, synovitis, and tenosynovitis assessed by Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS)

Timeframe: 24 weeks

Secondary Outcome Measures

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

Study Documents

Plain Language Summary of Results
Available Language(s): English, German (Austria), Danish, German, Spanish, Spanish (United States), French (Canadian), French, Italian, Dutch

Locations

Location
Status
Contact Us
Location
Austin Regional Clinic
Austin, TX, United States, 78731
Status
Recruiting
Location
NYU Langone Medical Center
New York, NY, United States, 10003
Status
Recruiting
Location
Integral Rheumatology and Immunology Specialists
Plantation, FL, United States, 33324
Status
Recruiting
Location
Swedish Medical Center
Seattle, WA, United States, 98104
Status
Recruiting
Location
Aalborg Universitetshospital
Aalborg, Denmark, 9000
Status
Recruiting
Location
Alberta Rheumatology
Edmonton, AB, Canada, T5M 0H4
Status
Recruiting
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