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ACTIVE: Apremilast Monotherapy in PsA
NCT01925768Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2013
- Primary completion
- Feb 2015
- Countries
- 10
- Sponsor
- Amgen
- Modality
- Small Molecules
- Drugs
- apremilast
- Conditions
- psoriatic arthritis (PsA)
01
Overview
Phase 3, randomised, double-blind trial in psoriatic arthritis (PsA) comparing Apremilast 30 mg with Placebo -> Apremilast (2 arms). Primary endpoint: American College of Rheumatology 20% Response at 16 weeks. Started Sep 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Apremilast 30 mg
Apremilast 30 mg BID throughout the study.
Placebo -> Apremilast
Placebo BID for first 24 weeks (or 16 weeks if early escape), then Apremilast 30 mg BID.
03
Who it enrols
Adults with active psoriatic arthritis (>=3 swollen and >=3 tender joints) for at least 3 months, who are biologic-naive and have not been treated with more than one non-biologic DMARD. Patients must have elevated hs-CRP.
04
Endpoints
Primary
American College of Rheumatology 20% Response
Secondary
Health Assessment Questionnaire-Disability Index
American College of Rheumatology 20% Response
Disease Activity Score 28-Joint Count C-Reactive Protein
Short Form-36 Physical Function Domain
Short Form-36 Physical Component Summary
Duration of Morning Stiffness
Severity of Morning Stiffness
Treatment Emergent Adverse Events
05
Results
Primary endpoints met
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