MedTrace Logo

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

NCT02198651 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2019-06-25

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BIOLOGICAL

Adalimumab

Pre-filled syringe, administered by subcutaneous injection

OTHER

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-05
Primary Completion
2018-05-03
Completion
2018-08-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02198651 on ClinicalTrials.gov