MedTrace Logo

An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis

NCT02049138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2022-07-12

Study results available
· View outcomes & findings →

Summary

The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.

Conditions

Interventions

DRUG

Upadacitinib

Tablet taken orally

BIOLOGICAL

Pneumococcal 13-valent conjugate vaccine (PCV-13)

Administered by intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-24
Primary Completion
2021-07-29
Completion
2021-07-29
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Chile
  • Czechia
  • Hungary
  • Israel
  • Latvia
  • Mexico
  • New Zealand
  • Poland
  • Puerto Rico
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02049138 on ClinicalTrials.gov