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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00085644
Date of registration: 10/06/2004
Prospective Registration: Yes
Primary sponsor: Abbott
Public title: Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis ATLAS
Scientific 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
Date of first enrolment: January 2004
Target sample size: 315
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00085644
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Laura Redden, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Abbott
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Biological: adalimumab (D2E7)
Biological: placebo
Primary Outcome(s)
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 [Time Frame: Week 104]
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). [Time Frame: Week 12]
Secondary Outcome(s)
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure [Time Frame: Baseline, Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260]
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 50 - Through Week 260 of Adalimumab Exposure [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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 [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure [Time Frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Secondary ID(s)
M03-607
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 11/03/2010
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00085644
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