Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankylosing Spondylitis
Intervention: adalimumab (D2E7) (Biological); placebo (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Laura Redden, MD, PhD, Study Director, Affiliation: Abbott
Summary
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).
Clinical Details
Official title: A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20).Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score
Secondary outcome: Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab ExposureNumber of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 50 - Through Week 260 of Adalimumab Exposure Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 70 - Through Week 260 of Adalimumab Exposure Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Number of Subjects With a Reduction of Signs and Symptoms as Measured in BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Number of Subjects With a Reduction of Signs and Symptoms as Measured in Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Number of Subjects With a Reduction of Signs and Symptoms as Measured in Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260 Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured by ASAS Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Birmingham, Alabama 35924, United States
Mobile, Alabama 36608, United States
San Francisco, California 94143, United States
Colorado Springs, Colorado 80910, United States
Denver, Colorado 80230, United States
Boise, Idaho 83706, United States
Chicago, Illinois 60611, United States
Indianapolis, Indiana 46260, United States
Portland, Maine 04102, United States
Baltimore,, Maryland 21224, United States
Wheaton, Maryland 20902, United States
Omaha, Nebraska 68114, United States
Lebanon, New Hampshire 03756, United States
Albany, New York 12206, United States
Oklahoma City, Oklahoma 73112, United States
Duncansville, Pennsylvania 16635, United States
West Reading, Pennsylvania 19611, United States
Dallas, Texas 75231, United States
Houston, Texas 77030, United States
Houston, Texas 77074, United States
Salt Lake City, Utah 84132, United States
Seattle, Washington 98104, United States
Additional Information
Starting date: January 2004
Last updated: April 18, 2011
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