A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects

Summary

The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.

Timeline

Start

2015-01-05

Primary completion

2018-05-03

Completion

2018-08-08

Outcome

Missed primary endpoint

paper Baseline MRI inflammation was not associated with flare occurrence. PMID 32404343 ↗

registry analysis (other test); Adalimumab Tapering; p = 0.943; Wald Chi NCT02198651 ↗

registry analysis (other test); Adalimumab Tapering; p = 0.592; Wald Chi NCT02198651 ↗

registry analysis (other test); Adalimumab Tapering; p = 0.688; Wald Chi NCT02198651 ↗

Publications

• Emery P, Burmester GR, Naredo E, Sinigaglia L, Lagunes I, Koenigsbauer F, Conaghan PG. Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study. Ann Rheum Dis. 2020 Aug;79(8):1023-1030. doi: 10.1136/annrheumdis-2020-217246. Epub 2020 May 13.
• Emery P, Burmester GR, Naredo E, Zhou Y, Hojnik M, Conaghan PG. Design of a phase IV randomised, double-blind, placebo-controlled trial assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) patients (PREDICTRA). BMJ Open. 2018 Feb 28;8(2):e019007. doi: 10.1136/bmjopen-2017-019007.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous

Indications