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Adalimumab Impact on Vascular Function in RA
NCT01954381Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2011
- Primary completion
- Oct 2014
- Countries
- 1
- Sponsor
- Assistance Publique-Hôpitaux de Marseille
- Modality
- Monoclonal Antibodies
- Drugs
- adalimumab
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 3, open-label trial of adalimumab in rheumatoid arthritis (RA) (2 arms), sponsored by Assistance Publique-Hôpitaux de Marseille. Primary endpoints: Post-ischaemic dilatation by 2D ultrasound, Pulse wave velocity at 24 weeks and 1 more. Started Oct 2011; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
RA Patients
Patients with RA receiving Adalimumab.
Control
Control group (likely baseline or healthy reference).
03
Who it enrols
Adult patients with moderately to severely active RA who have had an inadequate response to DMARDs including methotrexate, or severe active RA in patients not previously treated with methotrexate. Patients must have an indication for adalimumab therapy.
04
Endpoints
Primary
Post-ischaemic dilatation by 2D ultrasound
Pulse wave velocity
Central pulse pressure
Secondary
Resting blood pressure
Systolic pressure index
Structure of the carotid wall
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