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)

• Status: Completed
• Trial end date: 1969-12-31

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)

• Phase: Phase 3

Details

• Lead Sponsor: Abbott
• Treatments: Adalimumab