NCT00478660

An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)

Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,250 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Due to the rigor of the clinical development program of adalimumab for the indication of AS, the population of subjects with active AS that could enroll in previous phase 3 studies was limited. Therefore, it is necessary to further evaluate the use of adalimumab in a setting that mimics day-to-day clinical practice to obtain further safety and efficacy data by allowing subjects meeting the characteristics noted below to enter this study: * Subjects who failed another TNF inhibitor (etanercept, infliximab) * Subjects with advanced spinal ankylosis * Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	adalimumab (Humira)

Timeline

• Start date: 2006-02-01
• First posted: 2007-05-25
• Last updated: 2007-10-10

Locations

205 sites across 15 countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom