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)

Sponsor
Abbott
Study ID
NCT00478660
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Feb 28, 2006
Status verified
Oct 2007

Study Design

Enrollment
1,250 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

ASAS 20/40/50/70

Related Studies