MedTrace Logo

Efficacy and Safety of Adalimumab in Patients With Active Uveitis

NCT01138657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2021-07-07

Study results available
· View outcomes & findings →

Summary

A study comparing the safety and efficacy of adalimumab compared with placebo in patients with active uveitis.

Conditions

  • Uveitis

Interventions

BIOLOGICAL

Adalimumab

Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by a 40 mg dose eow starting at Week 1.

DRUG

Prednisone

Administered orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all participants continuing in the study were to discontinue prednisone no later than Week 15.

DRUG

Placebo

Administered by subcutaneous injection

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Andy Payne, PhD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2014-07-31
Completion
2014-08-31

More Related Trials

Entities

Drugs

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 NCT01138657 on ClinicalTrials.gov