CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 149 enrolled
Drug / intervention
Adalimumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02198651
NCT02198651Phase 4Completed
CompareCT.gov

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 (PREDICTRA)

AbbVie·interventional·Posted Jul 24, 2014·Updated Jun 25, 2019

In Brief

A Phase 4 clinical trial evaluating Adalimumab and Placebo for Rheumatoid Arthritis and Musculoskeletal and Connective Tissue Diseases. Completed, enrolled 149 participants across 70 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis, Musculoskeletal and Connective Tissue Diseases
CountriesAustralia, Austria, Canada, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 24, 2014
Enrollment StartJan 5, 2015
Primary CompletionMay 3, 2018
Study CompletionAug 8, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.9 years ago

Interventions

Adalimumabbiological

Pre-filled syringe, administered by subcutaneous injection

Placeboother

Pre-filled syringe, administered by subcutaneous injection in the Double-blind period