ATLASA Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
adalimumab (D2E7)
+ placebo
Axial Spondyloarthritis+10
+ Ankylosis
+ Arthritis
Treatment Study
Summary
Study start date: January 1, 2004
Actual date on which the first participant was enrolled.The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.315 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Subjects must be \>= 18 years of age * meet Modified NY Criteria definition of ankylosing spondylitis (AS) * have diagnosis of active AS based on protocol specified criteria * inadequate response or intolerance to \>= 1 nonsteroidal antiinflammatory drug (NSAID) * be able and willing to learn to self-administer subcutaneous (SC) injections Exclusion Criteria: * Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C * History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease * Previous anti-tumor necrosis factor therapy * Treatment with disease-modifying antirheumatic drugs (DMARDs - other than methotrexate, hydroxychloroquine, and sulfasalazine) * Treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing * Biologic or investigational therapy within 6 weeks of study dosing * Treatment with intravenous (IV) antibiotics within 30 days of study dosing * Treatment with oral antibiotics within 14 days of study dosing
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives