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A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation

2016-06-27 20:53:21 | BioPortfolio

Summary

An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in subjects with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 is designed to compare the achievement of minimal disease activity (MDA) between subjects randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 is to evaluate the maintenance or achievement of MDA on four different treatment regimens using adalimumab and/or MTX, with subject allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Psoriatic Arthritis

Intervention

adalimumab, methotrexate (MTX)

Status

Not yet recruiting

Source

AbbVie

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-27T20:53:21-0400

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