A Phase 3 interventional study of adalimumab (D2E7) and placebo in Ankylosing Spondylitis, sponsored by Abbott. Completed at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-21.
Sponsored by Abbott · Phase 3, Interventional, and Treatment
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).
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 315 is above the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: adalimumab (D2E7)
Biological: placebo
Adalimumab 40 mg every other week, subcutaneous
Also known as: ABT-D2E7, adalimumab, Humira
Placebo every other week, subcutaneous
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).
ASAS 20 responders - improvement of \>=20% and absolute improvement of \>=10 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 \[none\]-100 \[severe\]), Total Back Pain VAS (0 \[no pain\]-100 \[severe\]), BASFI VAS (0 \[easy\]-100\[impossible\]); and Inflammation VAS (0 \[none\]-10 \[very severe\]) and absence of deterioration in the potential remaining domain, defined as a worsening of \>=20% and a net worsening of \>=10 units. Applied to each scale and not to an overall global scale.
Time frame: Week 12
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
Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 \[no change\] to 72 \[progression\]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.
Time frame: Week 104
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
ASAS 20 responders - improvement of \>=20% and absolute improvement of \>=10 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0\[none\]-100 \[severe\]), Total Back Pain VAS; (0 \[no pain\]-100 \[severe\]), BASFI VAS (0 \[easy \]-100\[impossible\]); and Inflammation VAS (0 \[none\] to 10 \[very severe\]) and absence of deterioration in the potential remaining domain, defined as a worsening of \>=20% and a net worsening of \>=10 units. Applied to each scale and not to an overall global scale.
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
ASAS 50 responders - improvement of \>=50% and absolute improvement of \>=20 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 \[none\] to 100 \[severe\]); Total Back Pain VAS (0 \[no pain\] to 100 \[severe\]); BASFI VAS (0 \[easy\] to 100\[impossible\]); and Inflammation VAS (1 \[none\] to 10 \[very severe\]); and absence of deterioration in the potential remaining domain, defined as a worsening of \>=20% and a net worsening of \>=10 units. Applied to each scale and not to an overall global scale.
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
ASAS 70 responders - improvement of \>=70% and absolute improvement of \>=30 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 \[none\] to 100 \[severe\]), Total Back Pain VAS; (0 \[no pain\] - 100 \[severe\]), BASFI VAS (0 \[easy\] to 100\[impossible\]); and Inflammation VAS (1 \[none\] to 10 \[very severe\]); and absence of deterioration in the potential remaining domain, defined as defined as a worsening of \>= 20% and a net worsening of \>= 10 units. Applied to each scale and not to an overall global scale.
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
Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
Time frame: Baseline, 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
The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.
Time frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260
BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 100-mm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 100 (impossible).
Time frame: Baseline, 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
BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.
Time frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260
Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).
Time frame: Baseline, 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
Participants assessed disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain). A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.
Time frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260
The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 \[none\] to 10 \[very severe\]) and duration of morning stiffness (0 \[0 hours\] to 10 \[2 or more hours\]). A decrease in inflammation represents improvement.
Time frame: Baseline, 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
The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 \[none\] to 10 \[very severe\]) and duration of morning stiffness (0 \[0 hours\] to 10 \[2 or more hours\]). A decrease in inflammation represents improvement. A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 \[none\] to 10 \[very severe\].
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
The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).
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
The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).
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
The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).
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
The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).
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
Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation. A decrease in CRP indicates improvement.
Time frame: Baseline, 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
ASAS 40 responders - improvement of \>=40% and absolute improvement of \>=20 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 \[none\] to 100 \[severe\]); Total Back Pain VAS (0 \[no pain\] to 100 \[severe\]); BASFI VAS (0 \[easy\] to 100\[impossible\]); and Inflammation VAS (1 \[none\] to 10 \[very severe\]); and absence of any deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.
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
The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage. ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function \[BASFI\], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation \[mean of Questions 5 and 6 of the BASDAI\], spinal mobility \[BASMI\], and acute phase reactants \[CRP\]).
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 by ASAS Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260
ASAS partial remission was calculated as follows: A value below 20 on a 0 - 100 point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function, and Inflammation). Partial remission is also regarded as a low disease activity state.
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
BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.
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 [
The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE. An increase in chest expansion represents improvement
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
MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 to 13 (minimum to maximum number and severity of enthesitis).
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
BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported.
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
Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present ("1"), absent ("0") or injected/replaced ("9"). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5).
Time frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260
Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present ("1"), absent ("0") or injected/replaced ("9"). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Hip, Knee, Ankle, and Metatarsophalangeal (1-5).
Time frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260
The physician will globally assess the subject's current disease state using a 100-mm VAS scale with 0 being very good and 100 being very bad.
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
The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.
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 Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.
Time frame: Baseline, 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
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning). Responders were subjects whose change in PCS score fulfilled the Minimal Clinically Important Difference (MCID). The MCID for PCS was determined by a \>= 3.0 point increase during exposure to adalimumab.
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 Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.
Time frame: Baseline, 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
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning). Responders were subjects whose change in MCS fulfilled the Minimal Clinically Important Difference (MCID). The MCID for MCS was determined by a \>= 3.0 point increase during exposure to adalimumab.
Time frame: 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
The HUI-3 is a generic approach to the measurement of health status and assessment of health-related quality of life (HRQL). The HUI-3 classification is comprised of a total score and 8 attributes - Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain. The attributes are measures on a scale from the worst score of 0 to best score of 1. The total score scale ranges from dead (= 0) and perfect health (= 1). The total score can have a negative score that is interpreted as worse than dead and the lower limit is -0.36. An increase in the HUI-3 score represents improvement.
Time frame: Baseline, Weeks 24, 52, 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
ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Each statement on the ASQoL is given a score of "1" or "0." All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement.
Time frame: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, 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
ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are participants with a minimal clinically important difference (MCID) \<= -1.8 points. MCID was determined by a \>= 1.8 score decrease during exposure to adalimumab.
Time frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure
Completed by subject at each visit. The Patient Acceptable Symptoms State (PASS) was a participant-reported outcome where participants were expected to respond (yes/no) to the following question: Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?
Time frame: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260
Subjects diagnosed with active ankylosing spondylitis (AS) who have an inadequate response or intolerance to 1 or more nonsteroidal antiinflammatory drugs and who may have also failed 1 or more therapies with disease-modifying antirheumatic drugs.
| Milestone | Adalimumab | Placebo | Any Adalimumab |
|---|---|---|---|
| Started | 208 | 107 | 0 |
| Completed | 195 | 101 | 0 |
| Not completed | 13 | 6 | 0 |
| Withdrew: Adverse event | 5 | 2 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 | 0 |
| Withdrew: Lack/loss of efficacy | 2 | 2 | 0 |
| Withdrew: Contemplating pregnancy | 1 | 0 | 0 |
| Withdrew: Undiagnosed pre-existing condition | 0 | 1 | 0 |
| Milestone | Adalimumab | Placebo | Any Adalimumab |
|---|---|---|---|
| Started | 0 | 0 | 311 |
| Completed | 0 | 0 | 202 |
| Not completed | 0 | 0 | 109 |
| Withdrew: Adverse event | 0 | 0 | 38 |
| Withdrew: Withdrawal by subject | 0 | 0 | 29 |
| Withdrew: Lost to follow-up | 0 | 0 | 13 |
| Withdrew: Lack of efficacy | 0 | 0 | 15 |
| Withdrew: Pregnancy | 0 | 0 | 3 |
| Withdrew: Contemplating pregnancy | 0 | 0 | 3 |
| Withdrew: Protocol violation | 0 | 0 | 4 |
| Withdrew: Personal reason | 0 | 0 | 4 |
ASAS 20 responders - improvement of \>=20% and absolute improvement of \>=10 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 \[none\]-100 \[severe\]), Total Back Pain VAS (0 \[no pain\]-100 \[severe\]), BASFI VAS (0 \[easy\]-100\[impossible\]); and Inflammation VAS (0 \[none\]-10 \[very severe\]) and absence of deterioration in the potential remaining domain, defined as a worsening of \>=20% and a net worsening of \>=10 units. Applied to each scale and not to an overall global scale.
| Participants (responders, nonresponders) | Adalimumab | Placebo |
|---|---|---|
| Responder | 121 | 22 |
| Nonresponder | 83 | 82 |
| Missing | 4 | 3 |
Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 \[no change\] to 72 \[progression\]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.
| score on a scale | Any Adalimumab |
|---|---|
| Adalimumab in M03-607 (N = 237) | 0.9 ± 0.19 |
| OASIS (N = 169) | 0.9 ± 0.23 |
ASAS 20 responders - improvement of \>=20% and absolute improvement of \>=10 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0\[none\]-100 \[severe\]), Total Back Pain VAS; (0 \[no pain\]-100 \[severe\]), BASFI VAS (0 \[easy \]-100\[impossible\]); and Inflammation VAS (0 \[none\] to 10 \[very severe\]) and absence of deterioration in the potential remaining domain, defined as a worsening of \>=20% and a net worsening of \>=10 units. Applied to each scale and not to an overall global scale.
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 171 |
| Week 24 Responders (n = 298) | 204 |
| Week 52 Responders (n = 282) | 198 |
| Week 76 Responders (n = 269) | 199 |
| Week 104 Responders (n = 261) | 192 |
| Week 128 Responders (n = 242) | 181 |
| Week 156 Responders (n = 234) | 174 |
| Week 180 Responders (n = 226) | 180 |
| Week 208 Responders (n = 217) | 172 |
| Week 220 Responders (n = 210) | 170 |
| Week 232 Responders (n = 204) | 162 |
| Week 244 Responders (n = 187) | 153 |
| Week 260 Responders (n = 125) | 111 |
ASAS 50 responders - improvement of \>=50% and absolute improvement of \>=20 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 \[none\] to 100 \[severe\]); Total Back Pain VAS (0 \[no pain\] to 100 \[severe\]); BASFI VAS (0 \[easy\] to 100\[impossible\]); and Inflammation VAS (1 \[none\] to 10 \[very severe\]); and absence of deterioration in the potential remaining domain, defined as a worsening of \>=20% and a net worsening of \>=10 units. Applied to each scale and not to an overall global scale.
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 105 |
| Week 24 Responders (n = 298) | 122 |
| Week 52 Responders (n = 282) | 131 |
| Week 76 Responders (n = 269) | 144 |
| Week 104 Responders (n = 261) | 144 |
| Week 128 Responders (n = 242) | 127 |
| Week 156 Responders (n = 234) | 137 |
| Week 180 Responders (n = 226) | 131 |
| Week 208 Responders (n = 217) | 121 |
| Week 220 Responders (n = 210) | 130 |
| Week 232 Responders (n = 204) | 125 |
| Week 244 Responders (n = 187) | 111 |
| Week 260 Responders (n = 125) | 86 |
ASAS 70 responders - improvement of \>=70% and absolute improvement of \>=30 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 \[none\] to 100 \[severe\]), Total Back Pain VAS; (0 \[no pain\] - 100 \[severe\]), BASFI VAS (0 \[easy\] to 100\[impossible\]); and Inflammation VAS (1 \[none\] to 10 \[very severe\]); and absence of deterioration in the potential remaining domain, defined as defined as a worsening of \>= 20% and a net worsening of \>= 10 units. Applied to each scale and not to an overall global scale.
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 62 |
| Week 24 Responders (n = 298) | 74 |
| Week 52 Responders (n = 282) | 91 |
| Week 76 Responders (n = 269) | 99 |
| Week 104 Responders (n = 261) | 102 |
| Week 128 Responders (n = 242) | 98 |
| Week 156 Responders (n = 234) | 97 |
| Week 180 Responders (n = 226) | 90 |
| Week 208 Responders (n = 217) | 93 |
| Week 220 Responders (n = 210) | 87 |
| Week 232 Responders (n = 204) | 89 |
| Week 244 Responders (n = 187) | 88 |
| Week 260 Responders (n = 125) | 69 |
Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.
| mm | Any Adalimumab |
|---|---|
| Week 12 (n = 309) | -25.24 ± 28.029 |
| Week 24 (n = 297) | -31.07 ± 27.663 |
| Week 52 (n = 281) | -33.62 ± 27.803 |
| Week 76 (n = 268) | -36.58 ± 27.425 |
| Week 104 (n = 260) | -37.21 ± 29.090 |
| Week 128 (n = 241) | -38.10 ± 28.778 |
| Week 156 (n = 233) | -39.11 ± 28.510 |
| Week 180 (n = 225) | -40.30 ± 26.378 |
| Week 208 (n = 216) | -39.87 ± 28.222 |
| Week 220 (n = 209) | -40.44 ± 27.913 |
| Week 232 (n = 203) | -40.69 ± 27.205 |
| Week 244 (n = 186) | -41.19 ± 26.962 |
| Week 260 (n = 124) | -45.50 ± 24.849 |
The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 309) | 192 |
| Week 24 Responders (n = 297) | 214 |
| Week 52 Responders (n = 281) | 213 |
| Week 76 Responders (n = 268) | 211 |
| Week 104 Responders (n = 260) | 201 |
| Week 128 Responders (n = 241) | 185 |
| Week 156 Responders (n = 233) | 184 |
| Week 180 Responders (n = 225) | 184 |
| Week 208 Responders (n = 216) | 179 |
| Week 220 Responders (n = 209) | 175 |
| Week 232 Responders (n = 203) | 168 |
| Week 244 Responders (n = 186) | 160 |
| Week 260 Responders (n = 124) | 112 |
BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 100-mm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 100 (impossible).
| mm | Any Adalimumab |
|---|---|
| Week 12 (n = 310) | -16.12 ± 19.369 |
| Week 24 (n = 298) | -20.45 ± 19.831 |
| Week 52 (n = 282) | -22.94 ± 21.005 |
| Week 76 (n = 269) | -25.13 ± 21.087 |
| Week 104 (n = 261) | -26.24 ± 22.391 |
| Week 128 (n = 242) | -26.52 ± 21.811 |
| Week 156 (n = 234) | -27.24 ± 22.802 |
| Week 180 (n = 226) | -28.35 ± 21.745 |
| Week 208 (n = 217) | -27.92 ± 21.656 |
| Week 220 (n = 210) | -27.70 ± 22.216 |
| Week 232 (n = 205) | -28.30 ± 22.418 |
| Week 244 (n = 187) | -29.33 ± 21.612 |
| Week 260 (n = 125) | -31.44 ± 20.508 |
BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 170 |
| Week 24 Responders (n = 298) | 190 |
| Week 52 Responders (n = 282) | 186 |
| Week 76 Responders (n = 269) | 188 |
| Week 104 Responders (n = 261) | 189 |
| Week 128 Responders (n = 242) | 179 |
| Week 156 Responders (n = 234) | 175 |
| Week 180 Responders (n = 226) | 177 |
| Week 208 Responders (n = 217) | 167 |
| Week 220 Responders (n = 210) | 160 |
| Week 232 Responders (n = 205) | 159 |
| Week 244 Responders (n = 187) | 148 |
| Week 260 Responders (n = 125) | 103 |
Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).
| mm | Any Adalimumab |
|---|---|
| Week 12 (n = 310) | -24.51 ± 28.334 |
| Week 24 (n = 298) | -31.02 ± 27.323 |
| Week 52 (n = 282) | -34.09 ± 28.646 |
| Week 76 (n = 269) | -36.55 ± 26.897 |
| Week 104 (n = 261) | -37.34 ± 29.839 |
| Week 128 (n = 242) | -38.15 ± 29.172 |
| Week 156 (n = 234) | -38.43 ± 28.667 |
| Week 180 (n = 226) | -39.40 ± 27.830 |
| Week 208 (n = 217) | -37.93 ± 30.306 |
| Week 220 (n = 210) | -39.30 ± 28.996 |
| Week 232 (n = 204) | -40.31 ± 29.449 |
| Week 244 (n = 187) | -41.66 ± 29.196 |
| Week 260 (n = 125) | -47.83 ± 24.636 |
Participants assessed disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain). A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 181 |
| Week 24 Responders (n = 298) | 210 |
| Week 52 Responders (n = 282) | 208 |
| Week 76 Responders (n = 269) | 204 |
| Week 104 Responders (n = 261) | 199 |
| Week 128 Responders (n = 242) | 188 |
| Week 156 Responders (n = 234) | 178 |
| Week 180 Responders (n = 226) | 186 |
| Week 208 Responders (n = 217) | 172 |
| Week 220 Responders (n = 210) | 165 |
| Week 232 Responders (n = 204) | 164 |
| Week 244 Responders (n = 187) | 157 |
| Week 260 Responders (n = 125) | 111 |
The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 \[none\] to 10 \[very severe\]) and duration of morning stiffness (0 \[0 hours\] to 10 \[2 or more hours\]). A decrease in inflammation represents improvement.
| cm | Any Adalimumab |
|---|---|
| Week 12 (n = 310) | -2.82 ± 2.700 |
| Week 24 (n = 298) | -3.48 ± 2.640 |
| Week 52 (n = 282) | -3.80 ± 2.743 |
| Week 76 (n = 269) | -3.98 ± 2.674 |
| Week 104 (n = 261) | -4.12 ± 2.780 |
| Week 128 (n = 242) | -4.04 ± 2.754 |
| Week 156 (n = 234) | -3.93 ± 3.978 |
| Week 180 (n = 226) | -4.24 ± 2.664 |
| Week 208 (n = 217) | -4.27 ± 2.677 |
| Week 220 (n = 210) | -4.29 ± 2.677 |
| Week 232 (n = 205) | -4.30 ± 2.700 |
| Week 244 (n = 186) | -4.56 ± 2.610 |
| Week 260 (n = 124) | -4.94 ± 2.470 |
The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 \[none\] to 10 \[very severe\]) and duration of morning stiffness (0 \[0 hours\] to 10 \[2 or more hours\]). A decrease in inflammation represents improvement. A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 \[none\] to 10 \[very severe\].
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 198 |
| Week 24 Responders (n = 298) | 231 |
| Week 52 Responders (n = 282) | 224 |
| Week 76 Responders (n = 269) | 221 |
| Week 104 Responders (n = 261) | 215 |
| Week 128 Responders (n = 242) | 230 |
| Week 156 Responders (n = 234) | 192 |
| Week 180 Responders (n = 226) | 191 |
| Week 208 Responders (n = 217) | 191 |
| Week 220 Responders (n = 210) | 182 |
| Week 232 Responders (n = 205) | 176 |
| Week 244 Responders (n = 186) | 165 |
| Week 260 Responders (n = 124) | 114 |
The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 205 |
| Week 24 Responders (n = 298) | 225 |
| Week 52 Responders (n = 282) | 218 |
| Week 76 Responders (n = 269) | 219 |
| Week 104 Responders (n = 261) | 212 |
| Week 128 Responders (n = 242) | 202 |
| Week 156 Responders (n = 234) | 192 |
| Week 180 Responders (n = 226) | 201 |
| Week 208 Responders (n = 217) | 190 |
| Week 220 Responders (n = 210) | 181 |
| Week 232 Responders (n = 205) | 183 |
| Week 244 Responders (n = 187) | 170 |
| Week 260 Responders (n = 124) | 117 |
The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 133 |
| Week 24 Responders (n = 298) | 157 |
| Week 52 Responders (n = 282) | 169 |
| Week 76 Responders (n = 269) | 173 |
| Week 104 Responders (n = 261) | 170 |
| Week 128 Responders (n = 242) | 155 |
| Week 156 Responders (n = 234) | 156 |
| Week 180 Responders (n = 226) | 155 |
| Week 208 Responders (n = 217) | 147 |
| Week 220 Responders (n = 210) | 148 |
| Week 232 Responders (n = 205) | 145 |
| Week 244 Responders (n = 187) | 135 |
| Week 260 Responders (n = 124) | 96 |
The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 80 |
| Week 24 Responders (n = 298) | 103 |
| Week 52 Responders (n = 282) | 113 |
| Week 76 Responders (n = 269) | 114 |
| Week 104 Responders (n = 261) | 129 |
| Week 128 Responders (n = 242) | 115 |
| Week 156 Responders (n = 234) | 119 |
| Week 180 Responders (n = 226) | 110 |
| Week 208 Responders (n = 217) | 113 |
| Week 220 Responders (n = 210) | 109 |
| Week 232 Responders (n = 205) | 110 |
| Week 244 Responders (n = 187) | 104 |
| Week 260 Responders (n = 124) | 76 |
The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).
| cm | Any Adalimumab |
|---|---|
| Week 12 (n = 310) | -2.38 ± 2.377 |
| Week 24 (n = 298) | -2.90 ± 2.418 |
| Week 52 (n = 282) | -3.16 ± 2.547 |
| Week 76 (n = 269) | -3.38 ± 2.384 |
| Week 104 (n = 261) | -3.54 ± 2.519 |
| Week 128 (n = 242) | -3.53 ± 2.421 |
| Week 156 (n = 234) | -3.45 ± 3.491 |
| Week 180 (n = 226) | -3.79 ± 2.349 |
| Week 208 (n = 217) | -3.78 ± 2.352 |
| Week 220 (n = 210) | -3.73 ± 2.350 |
| Week 232 (n = 205) | -3.79 ± 2.395 |
| Week 244 (n = 187) | -4.08 ± 2.248 |
| Week 260 (n = 124) | -4.44 ± 2.227 |
Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation. A decrease in CRP indicates improvement.
| mg/dL | Any Adalimumab |
|---|---|
| Week 12 (n = 308) | -1.27 ± 2.092 |
| Week 24 (n = 294) | -1.24 ± 2.275 |
| Week 52 (n = 279) | -1.30 ± 2.221 |
| Week 76 (n = 264) | -1.35 ± 2.314 |
| Week 104 (n = 258) | -1.45 ± 2.333 |
| Week 128 (n = 238) | -1.36 ± 2.589 |
| Week 156 (n = 230) | -1.46 ± 2.604 |
| Week 180 (n = 224) | -1.54 ± 2.530 |
| Week 208 (n = 215) | -1.54 ± 2.740 |
| Week 220 (n = 207) | -1.50 ± 2.956 |
| Week 232 (n = 203) | -1.57 ± 2.709 |
| Week 244 (n = 186) | -1.58 ± 2.748 |
| Week 260 (n = 123) | -1.67 ± 2.623 |
ASAS 40 responders - improvement of \>=40% and absolute improvement of \>=20 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 \[none\] to 100 \[severe\]); Total Back Pain VAS (0 \[no pain\] to 100 \[severe\]); BASFI VAS (0 \[easy\] to 100\[impossible\]); and Inflammation VAS (1 \[none\] to 10 \[very severe\]); and absence of any deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 115 |
| Week 24 Responders (n = 298) | 144 |
| Week 52 Responders (n = 282) | 143 |
| Week 76 Responders (n = 269) | 157 |
| Week 104 Responders (n = 261) | 155 |
| Week 128 Responders (n = 242) | 140 |
| Week 156 Responders (n = 234) | 147 |
| Week 180 Responders (n = 226) | 143 |
| Week 208 Responders (n = 217) | 131 |
| Week 220 Responders (n = 210) | 134 |
| Week 232 Responders (n = 204) | 134 |
| Week 244 Responders (n = 187) | 118 |
| Week 260 Responders (n = 125) | 88 |
The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage. ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function \[BASFI\], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation \[mean of Questions 5 and 6 of the BASDAI\], spinal mobility \[BASMI\], and acute phase reactants \[CRP\]).
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 309) | 145 |
| Week 24 Responders (n = 297) | 184 |
| Week 52 Responders (n = 281) | 169 |
| Week 76 Responders (n = 268) | 179 |
| Week 104 Responders (n = 260) | 177 |
| Week 128 Responders (n = 241) | 159 |
| Week 156 Responders (n = 232) | 157 |
| Week 180 Responders (n = 225) | 160 |
| Week 208 Responders (n = 216) | 152 |
| Week 220 Responders (n = 208) | 148 |
| Week 232 Responders (n = 203) | 144 |
| Week 244 Responders (n = 186) | 132 |
| Week 260 Responders (n = 125) | 95 |
ASAS partial remission was calculated as follows: A value below 20 on a 0 - 100 point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function, and Inflammation). Partial remission is also regarded as a low disease activity state.
| participants | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | 62 |
| Week 24 Responders (n = 298) | 75 |
| Week 52 Responders (n = 282) | 94 |
| Week 76 Responders (n = 269) | 101 |
| Week 104 Responders (n = 261) | 100 |
| Week 128 Responders (n = 242) | 97 |
| Week 156 Responders (n = 234) | 96 |
| Week 180 Responders (n = 226) | 87 |
| Week 208 Responders (n = 217) | 86 |
| Week 220 Responders (n = 210) | 78 |
| Week 232 Responders (n = 204) | 96 |
| Week 244 Responders (n = 186) | 74 |
| Week 260 Responders (n = 124) | 63 |
BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.
| score on a scale | Any Adalimumab |
|---|---|
| Week 12 (n = 309) | -0.43 ± 1.313 |
| Week 24 (n = 294) | -0.60 ± 1.397 |
| Week 52 (n = 282) | -0.73 ± 1.375 |
| Week 76 (n = 268) | -0.77 ± 1.400 |
| Week 104 (n = 261) | -0.70 ± 1.502 |
| Week 128 (n = 242) | -0.67 ± 1.442 |
| Week 156 (n = 233) | -0.80 ± 1.472 |
| Week 180 (n = 225) | -0.70 ± 1.530 |
| Week 208 (n = 215) | -0.75 ± 1.535 |
| Week 220 (n = 208) | -0.74 ± 1.592 |
| Week 232 (n = 201) | -0.71 ± 1.579 |
| Week 244 (n = 187) | -0.68 ± 1.500 |
| Week 260 (n = 124) | -0.76 ± 1.521 |
The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE. An increase in chest expansion represents improvement
| cm | Any Adalimumab |
|---|---|
| Week 12 (n = 277) | 0.34 ± 1.570 |
| Week 24 (n = 237) | 0.25 ± 1.445 |
| Week 52 (n = 234) | 0.71 ± 6.574 |
| Week 104 (n = 261) | 0.59 ± 1.632 |
| Week 128 (n = 199) | 1.24 ± 7.627 |
| Week 156 (n = 230) | 0.58 ± 1.722 |
| Week 180 (n = 184) | 0.42 ± 1.865 |
| Week 208 (n = 202) | 0.96 ± 5.877 |
| Week 220 (n = 61) | 0.86 ± 1.962 |
| Week 232 (n = 142) | 0.60 ± 2.657 |
| Week 244 (n = 61) | 2.61 ± 15.450 |
| Week 260 (n = 123) | 1.25 ± 9.479 |
MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 to 13 (minimum to maximum number and severity of enthesitis).
| score on a scale | Any Adalimumab |
|---|---|
| Week 12 (n = 308) | -2.25 ± 5.888 |
| Week 24 (n = 294) | -2.97 ± 5.924 |
| Week 52 (n = 279) | -3.28 ± 5.908 |
| Week 76 (n = 226) | -3.27 ± 5.864 |
| Week 104 (n = 259) | -3.43 ± 6.560 |
| Week 128 (n = 201) | -3.18 ± 6.043 |
| Week 156 (n = 229) | -3.28 ± 6.154 |
| Week 180 (n = 184) | -3.44 ± 5.699 |
| Week 208 (n = 214) | -3.38 ± 6.070 |
| Week 232 (n = 170) | -3.25 ± 5.718 |
| Week 260 (n = 167) | -4.06 ± 6.528 |
BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported.
| score on a scale | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 309) | -20.55 ± 22.143 |
| Week 24 Responders (n = 293) | -29.74 ± 24.558 |
| Week 52 Responders (n = 281) | -35.48 ± 25.949 |
| Week 76 Responders (n = 269) | -39.29 ± 25.817 |
| Week 104 Responders (n = 261) | -40.36 ± 27.532 |
| Week 128 Responders (n = 242) | -41.47 ± 26.244 |
| Week 156 Responders (n = 234) | -40.66 ± 26.834 |
| Week 180 Responders (n = 226) | -42.59 ± 25.816 |
| Week 208 Responders (n = 217) | -42.21 ± 26.698 |
| Week 220 Responders (n = 209) | -41.85 ± 26.493 |
| Week 232 Responders (n = 205) | -41.59 ± 26.898 |
| Week 244 Responders (n = 187) | -44.86 ± 25.016 |
| Week 260 Responders (n = 125) | -47.66 ± 24.845 |
Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present ("1"), absent ("0") or injected/replaced ("9"). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5).
| score on a scale | Any Adalimumab |
|---|---|
| Week 12 (n = 311) | -0.18 ± 3.280 |
| Week 24 (n = 295) | -0.40 ± 2.608 |
| Week 52 (n = 281) | -0.36 ± 3.360 |
| Week 76 (n = 231) | -0.59 ± 3.044 |
| Week 104 (n = 261) | -0.60 ± 3.723 |
| Week 128 (n = 200) | -0.79 ± 3.434 |
| Week 156 (n = 231) | -0.60 ± 3.446 |
| Week 180 (n = 187) | -0.69 ± 3.669 |
| Week 208 (n = 215) | -0.54 ± 4.412 |
| Week 232 (n = 170) | -0.74 ± 3.822 |
| Week 260 (n = 169) | -0.70 ± 3.863 |
Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present ("1"), absent ("0") or injected/replaced ("9"). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Hip, Knee, Ankle, and Metatarsophalangeal (1-5).
| score on a scale | Any Adalimumab |
|---|---|
| Week 12 (n = 311) | -1.09 ± 5.193 |
| Week 24 (n = 295) | -1.41 ± 5.297 |
| Week 52 (n = 281) | -1.70 ± 6.330 |
| Week 76 (n = 231) | -1.87 ± 6.007 |
| Week 104 (n = 261) | -2.22 ± 6.816 |
| Week 128 (n = 202) | -2.16 ± 6.161 |
| Week 156 (n = 233) | -2.28 ± 5.361 |
| Week 180 (n = 187) | -2.88 ± 5.358 |
| Week 208 (n = 215) | -2.44 ± 5.270 |
| Week 232 (n = 171) | -2.76 ± 5.402 |
| Week 260 (n = 169) | -2.63 ± 6.348 |
The physician will globally assess the subject's current disease state using a 100-mm VAS scale with 0 being very good and 100 being very bad.
| mm | Any Adalimumab |
|---|---|
| Week 12 Responders (n = 310) | -24.36 ± 26.877 |
| Week 24 Responders (n = 297) | -29.69 ± 27.662 |
| Week 52 Responders (n = 281) | -34.01 ± 26.066 |
| Week 76 Responders (n = 267) | -37.16 ± 23.291 |
| Week 104 Responders (n = 260) | -37.58 ± 25.726 |
| Week 128 Responders (n = 239) | -38.17 ± 26.787 |
| Week 156 Responders (n = 233) | -38.10 ± 25.726 |
| Week 180 Responders (n = 225) | -39.76 ± 23.903 |
| Week 208 Responders (n = 215) | -39.30 ± 24.764 |
| Week 220 Responders (n = 209) | -39.44 ± 24.361 |
| Week 232 Responders (n = 203) | -38.46 ± 25.529 |
| Week 244 Responders (n = 186) | -43.14 ± 22.824 |
| Week 260 Responders (n = 124) | -43.83 ± 19.383 |
The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.
| mm | Any Adalimumab |
|---|---|
| Week 12 (n = 309) | -24.29 ± 29.281 |
| Week 24 (n = 297) | -30.85 ± 28.473 |
| Week 52 (n = 281) | -33.91 ± 30.280 |
| Week 76 (n = 268) | -37.17 ± 27.931 |
| Week 104 (n = 260) | -36.71 ± 30.261 |
| Week 128 (n = 241) | -37.52 ± 30.796 |
| Week 156 (n = 233) | -37.33 ± 29.194 |
| Week 180 (n = 225) | -38.68 ± 29.810 |
| Week 208 (n = 216) | -37.62 ± 30.925 |
| Week 220 (n = 209) | -38.43 ± 30.946 |
| Week 232 (n = 203) | -39.53 ± 30.433 |
| Week 244 (n = 186) | -40.73 ± 30.098 |
| Week 260 (n = 124) | -45.19 ± 26.944 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.
| score on a scale | Any Adalimumab |
|---|---|
| Week 12 (n = 278) | 6.92 ± 8.764 |
| Week 24 (n = 237) | 7.30 ± 8.678 |
| Week 52 (n = 278) | 9.07 ± 9.629 |
| Week 76 (n = 227) | 9.70 ± 9.812 |
| Week 104 (n = 256) | 9.95 ± 10.646 |
| Week 128 (n = 196) | 10.01 ± 10.394 |
| Week 156 (n = 230) | 11.23 ± 9.998 |
| Week 180 (n = 184) | 10.67 ± 9.918 |
| Week 208 (n = 214) | 10.39 ± 10.214 |
| Week 232 (n = 168) | 10.76 ± 9.892 |
| Week 260 (n = 165) | 11.83 ± 9.907 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning). Responders were subjects whose change in PCS score fulfilled the Minimal Clinically Important Difference (MCID). The MCID for PCS was determined by a \>= 3.0 point increase during exposure to adalimumab.
| participants | Any Adalimumab |
|---|---|
| Week 12 (n = 278) | 178 |
| Week 24 (n = 237) | 162 |
| Week 52 (n = 278) | 198 |
| Week 76 (n = 227) | 166 |
| Week 104 (n = 256) | 194 |
| Week 128 (n = 196) | 141 |
| Week 156 (n = 230) | 186 |
| Week 180 (n = 184) | 138 |
| Week 208 (n = 214) | 156 |
| Week 232 (n = 168) | 130 |
| Week 260 (n = 165) | 129 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.
| score on a scale | Any Adalimumab |
|---|---|
| Week 12 (n = 278) | 3.18 ± 11.114 |
| Week 24 (n = 237) | 4.24 ± 9.757 |
| Week 52 (n = 278) | 4.56 ± 10.404 |
| Week 76 (n = 227) | 4.31 ± 10.907 |
| Week 104 (n = 256) | 4.42 ± 11.466 |
| Week 128 (n = 196) | 3.71 ± 10.519 |
| Week 156 (n = 230) | 4.19 ± 11.551 |
| Week 180 (n = 184) | 4.64 ± 11.056 |
| Week 208 (n = 214) | 5.50 ± 10.760 |
| Week 232 (n = 168) | 4.66 ± 10.131 |
| Week 260 (n = 165) | 5.74 ± 10.758 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning). Responders were subjects whose change in MCS fulfilled the Minimal Clinically Important Difference (MCID). The MCID for MCS was determined by a \>= 3.0 point increase during exposure to adalimumab.
| participants | Any Adalimumab |
|---|---|
| Week 12 (n = 278) | 132 |
| Week 24 (n = 237) | 121 |
| Week 52 (n = 278) | 137 |
| Week 76 (n = 227) | 120 |
| Week 104 (n = 256) | 132 |
| Week 128 (n = 196) | 100 |
| Week 156 (n = 230) | 115 |
| Week 180 (n = 184) | 94 |
| Week 208 (n = 214) | 116 |
| Week 232 (n = 168) | 88 |
| Week 260 (n = 165) | 97 |
The HUI-3 is a generic approach to the measurement of health status and assessment of health-related quality of life (HRQL). The HUI-3 classification is comprised of a total score and 8 attributes - Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain. The attributes are measures on a scale from the worst score of 0 to best score of 1. The total score scale ranges from dead (= 0) and perfect health (= 1). The total score can have a negative score that is interpreted as worse than dead and the lower limit is -0.36. An increase in the HUI-3 score represents improvement.
| score on a scale | Any Adalimumab |
|---|---|
| Week 24 (n = 303) | 0.18 ± 0.245 |
| Week 52 (n = 239) | 0.20 ± 0.258 |
| Week 104 (n = 263) | 0.20 ± 0.258 |
| Week 128 (n = 201) | 0.20 ± 0.245 |
| Week 156 (n = 232) | 0.22 ± 0.274 |
| Week 180 (n = 187) | 0.22 ± 0.245 |
| Week 208 (n = 216) | 0.22 ± 0.244 |
| Week 232 (n = 171) | 0.23 ± 0.247 |
| Week 260 (n = 166) | 0.26 ± 0.244 |
ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Each statement on the ASQoL is given a score of "1" or "0." All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement.
| score on a scale | Any Adalimumab |
|---|---|
| Week 12 (n = 284) | -3.26 ± 4.144 |
| Week 24 (n = 242) | -3.69 ± 4.081 |
| Week 52 (n = 281) | -4.29 ± 4.475 |
| Week 76 (n = 232) | -4.36 ± 4.383 |
| Week 104 (n = 261) | -4.80 ± 4.497 |
| Week 128 (n = 202) | -4.59 ± 4.501 |
| Week 156 (n = 233) | -5.05 ± 4.630 |
| Week 180 (n = 186) | -4.95 ± 4.526 |
| Week 208 (n = 217) | -5.18 ± 4.406 |
| Week 232 (n = 173) | -5.09 ± 4.052 |
| Week 260 (n = 169) | -5.66 ± 4.188 |
ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are participants with a minimal clinically important difference (MCID) \<= -1.8 points. MCID was determined by a \>= 1.8 score decrease during exposure to adalimumab.
| participants | Any Adalimumab |
|---|---|
| Week 12 (n = 284) | 176 |
| Week 24 (n = 242) | 160 |
| Week 52 (n = 281) | 204 |
| Week 76 (n = 232) | 170 |
| Week 104 (n = 261) | 198 |
| Week 128 (n = 202) | 151 |
| Week 156 (n = 233) | 179 |
| Week 180 (n = 186) | 144 |
| Week 208 (n = 217) | 169 |
| Week 232 (n = 173) | 139 |
| Week 260 (n = 169) | 142 |
Completed by subject at each visit. The Patient Acceptable Symptoms State (PASS) was a participant-reported outcome where participants were expected to respond (yes/no) to the following question: Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?
| participants | Any Adalimumab |
|---|---|
| Week 12 (n = 310) | 140 |
| Week 24 (n = 298) | 153 |
| Week 52 (n = 282) | 164 |
| Week 76 (n = 269) | 162 |
| Week 104 (n = 259) | 172 |
| Week 128 (n = 194) | 124 |
| Week 156 (n = 230) | 161 |
| Week 180 (n = 185) | 127 |
| Week 208 (n = 212) | 144 |
| Week 232 (n = 172) | 122 |
| Week 260 (n = 165) | 112 |
Collected over Baseline through 260 weeks of adalimumab exposure. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Any Adalimumab | — | 96/311 (30.9%) | 279/311 (89.7%) |
| Event | Any Adalimumab |
|---|---|
| Chest painGeneral disorders | 5/311 |
| Myocardial infarctionCardiac disorders | 4/311 |
| Ankylosing spondylitisMusculoskeletal and connective tissue disorders | 4/311 |
| Atrial fibrillationCardiac disorders | 3/311 |
| Coronary artery diseaseCardiac disorders | 3/311 |
| CellullitisInfections and infestations | 3/311 |
| Inguinal herniaGastrointestinal disorders | 2/311 |
| AppendicitisInfections and infestations | 2/311 |
| PharyngitisInfections and infestations | 2/311 |
| Radius fractureInjury, poisoning and procedural complications | 2/311 |
| Event | Any Adalimumab |
|---|---|
| NasopharyngitisInfections and infestations | 110/311 |
| Upper respiratory tract infectionInfections and infestations | 77/311 |
| Ankylosing spondylitisMusculoskeletal and connective tissue disorders | 75/311 |
| HeadacheNervous system disorders | 60/311 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 54/311 |
| SinusitisInfections and infestations | 47/311 |
| HypertensionVascular disorders | 45/311 |
| CoughRespiratory, thoracic and mediastinal disorders | 44/311 |
| DiarrhoeaGastrointestinal disorders | 41/311 |
| BronchitisInfections and infestations | 41/311 |
| Age, Categorical(Participants) | Adalimumab | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 205 | 104 | 309 |
| >=65 years | 3 | 2 | 5 |
| Age Continuous(years) | Adalimumab | Placebo | Total |
|---|---|---|---|
| Mean | 41.7 ± 11.69 | 43.4 ± 11.32 | 42.2 ± 11.57 |
| Sex: Female, Male(Participants) | Adalimumab | Placebo | Total |
|---|---|---|---|
| Female | 51 | 28 | 79 |
| Male | 157 | 79 | 236 |
| Region of Enrollment(participants) | Adalimumab | Placebo | Total |
|---|---|---|---|
| United States | 100 | 48 | 148 |
| Europe | 108 | 59 | 167 |
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