NCT01064856

Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open label (OL) safety and efficacy assessments in participants with non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral spondyloarthritis (SpA) who have had an inadequate response to \>= 2 non-steroidal anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for, NSAIDs.

Conditions

• Peripheral Spondyloarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab	Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.
BIOLOGICAL	Placebo	Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-08-01
• Completion: 2014-05-01
• First posted: 2010-02-09
• Last updated: 2021-07-07
• Results posted: 2016-11-25