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

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.

Timeline

Start

2016-08-05

Primary completion

2019-09-23

Completion

2020-03-19

Publications

• Coates LC, Tillett W, D'Agostino MA, Rahman P, Behrens F, McDearmon-Blondell EL, Bu X, Chen L, Kapoor M, Conaghan PG, Mease P. Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 study. Lancet Rheumatol. 2022 Apr;4(4):e262-e273. doi: 10.1016/S2665-9913(22)00008-X. Epub 2022 Feb 25.

Drugs

Indications