Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis

NCT01808118 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 673

Last updated 2018-05-30

Study results available
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Summary

The objective of this multicenter, randomized, double-blind study was to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week SC in maintaining remission in subjects with moderate to severe non-radiographic axial spondyloarthritis.

Conditions

  • Axial Spondyloarthritis

Interventions

BIOLOGICAL

adalimumab

40 mg every other week

BIOLOGICAL

Placebo

every other week

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-04-16
Primary Completion
2017-02-21
Completion
2017-04-14
FDA Drug
Yes

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Entities

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 NCT01808118 on ClinicalTrials.gov