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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:  NCT00195819
Date of registration: 16/09/2005
Prospective Registration: No
Primary sponsor: Abbott
Public title: Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis
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: December 2003
Target sample size: 82
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00195819
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Canada United States
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject was age 18 or older and in relatively good health (Investigator discretion)
with a recent stable medical history.

- Subject met the definition of AS based on the Modified New York Criteria.

- Subject had an inadequate response to or intolerance to one or more NSAIDs as defined
by the Investigator

Exclusion Criteria:

- Subject had previously received anti-TNF therapy.

- Subject considered by the investigator, for any reason, to be an unsuitable candidate
for the study

- Female subject who is pregnant or breast-feeding or considering becoming pregnant



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: Baseline and Week 104]
Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 [Time Frame: Week 12]
Secondary Outcome(s)
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]
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]
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure [Time Frame: Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure [Time Frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in BASDAI 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]
Mean Change in C-Reactive Protein (CRP) (mg/dL) 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]
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Weeks 12, 24, 52,104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Weeks 12, 24, 52, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Baseline and at Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure [Time Frame: 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: 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: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Mean Change in Nocturnal Pain 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]
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Weeks 12, 24, 36, 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: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260]
Mean Change in Sacroiliac (SI) Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure [Time Frame: Weeks 12 and 52]
Mean Change in Spinal Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure [Time Frame: Week 12 and Week 52]
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 [Time Frame: Weeks 12, 24, 36, 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 and at 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: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 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: 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: 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: 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: 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: 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 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, 16, 20, 24, 30, 36, 42, 48, 52, 64, 76, 88, 104, 116, 128, 140, 156, 168, 180, 192, 208, 220, 232, 244, and 260]
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in 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 Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) 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) 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) 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 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 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 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: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260]
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure [Time Frame: Weeks 12, 24, 52, 76, 128, 152, 180, 208, 220, 232, 244, and 260]
Secondary ID(s)
M03-606
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 28/04/2010
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00195819
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