NCT02814175

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

A Phase 4 Open-label Randomized Controlled Study COmparing the Effectiveness of Adalimumab iNTROduction and Methotrexate Dose escaLation in Subjects With Psoriatic Arthritis (CONTROL)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week 32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment regimens using adalimumab and/or MTX, with participant allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	methotrexate (MTX)
BIOLOGICAL	adalimumab (ADA)

Timeline

• Start date: 2016-08-05
• Primary completion: 2019-09-23
• Completion: 2020-03-19
• First posted: 2016-06-27
• Last updated: 2020-11-23
• Results posted: 2020-11-23

Locations

60 sites across 14 countries: United States, Australia, Brazil, Bulgaria, Canada, Colombia, Czechia, Germany, Italy, Poland, Puerto Rico, Qatar, Spain, United Kingdom

Regulatory

• FDA-regulated drug study