Trial Outcomes & Findings for Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis (NCT NCT00085644)

Last Updated: 2011-04-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

315 participants

Primary outcome timeframe

Week 12

Results posted on

2011-04-21

Participant Flow

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.

Subjects were randomized 2:1 to receive either 40 mg adalimumab subcutaneous (sc) every other week (eow) or matched placebo for the 24-week double-blind placebo-controlled period of the study. After 12 weeks, subjects without a reduction of signs and symptoms in ankylosing spondylitis (ASAS 20) were considered for open-label adalimumab treatment.

Participant milestones

Participant milestones
Measure	Adalimumab Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.	Any Adalimumab 40 mg every other week (eow), subcutaneous (SC)
Double-Blind Period STARTED	208	107	0
Double-Blind Period COMPLETED	195	101	0
Double-Blind Period NOT COMPLETED	13	6	0
Open-Label Period STARTED	0	0	311
Open-Label Period COMPLETED	0	0	202
Open-Label Period NOT COMPLETED	0	0	109

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.	Any Adalimumab 40 mg every other week (eow), subcutaneous (SC)
Double-Blind Period Adverse Event	5	2	0
Double-Blind Period Withdrawal by Subject	3	0	0
Double-Blind Period Lost to Follow-up	2	1	0
Double-Blind Period Lack/loss of efficacy	2	2	0
Double-Blind Period Contemplating pregnancy	1	0	0
Double-Blind Period Undiagnosed pre-existing condition	0	1	0
Open-Label Period Adverse Event	0	0	38
Open-Label Period Withdrawal by Subject	0	0	29
Open-Label Period Lost to Follow-up	0	0	13
Open-Label Period Lack of Efficacy	0	0	15
Open-Label Period Pregnancy	0	0	3
Open-Label Period Contemplating pregnancy	0	0	3
Open-Label Period Protocol Violation	0	0	4
Open-Label Period Personal reason	0	0	4

Baseline Characteristics

Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab n=208 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo n=107 Participants Subjects on placebo treatment received SC injection of matched placebo every other week.	Total n=315 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	205 Participants n=5 Participants	104 Participants n=7 Participants	309 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age Continuous	41.7 years STANDARD_DEVIATION 11.69 • n=5 Participants	43.4 years STANDARD_DEVIATION 11.32 • n=7 Participants	42.2 years STANDARD_DEVIATION 11.57 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	28 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	157 Participants n=5 Participants	79 Participants n=7 Participants	236 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	48 participants n=7 Participants	148 participants n=5 Participants
Region of Enrollment Europe	108 participants n=5 Participants	59 participants n=7 Participants	167 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Adalimumab n=208 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo n=107 Participants Subjects on placebo treatment received SC injection of matched placebo every other week.
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). Responder	121 Participants (responders, nonresponders)	22 Participants (responders, nonresponders)
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). Nonresponder	83 Participants (responders, nonresponders)	82 Participants (responders, nonresponders)
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). Missing	4 Participants (responders, nonresponders)	3 Participants (responders, nonresponders)

PRIMARY outcome

Timeframe: Week 104

Population: The OASIS cohort is a historical control group of Dutch, French, and Belgian patients with AS who have been followed up since 1996. These patients participated in a follow-up study on the natural course of AS with conventional (non-biologic) treatment.

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=237 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Adalimumab in M03-607 (N = 237)	0.9 score on a scale Standard Error 0.19	—
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 OASIS (N = 169)	0.9 score on a scale Standard Error 0.23	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

Population: Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 310)	171 participants	—
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 Week 24 Responders (n = 298)	204 participants	—
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 Week 52 Responders (n = 282)	198 participants	—
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 Week 76 Responders (n = 269)	199 participants	—
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 Week 104 Responders (n = 261)	192 participants	—
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 Week 128 Responders (n = 242)	181 participants	—
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 Week 156 Responders (n = 234)	174 participants	—
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 Week 180 Responders (n = 226)	180 participants	—
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 Week 208 Responders (n = 217)	172 participants	—
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 Week 220 Responders (n = 210)	170 participants	—
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 Week 232 Responders (n = 204)	162 participants	—
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 Week 244 Responders (n = 187)	153 participants	—
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 Week 260 Responders (n = 125)	111 participants	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 310)	105 participants	—
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 Week 24 Responders (n = 298)	122 participants	—
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 Week 52 Responders (n = 282)	131 participants	—
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 Week 76 Responders (n = 269)	144 participants	—
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 Week 104 Responders (n = 261)	144 participants	—
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 Week 128 Responders (n = 242)	127 participants	—
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 Week 156 Responders (n = 234)	137 participants	—
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 Week 180 Responders (n = 226)	131 participants	—
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 Week 208 Responders (n = 217)	121 participants	—
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 Week 220 Responders (n = 210)	130 participants	—
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 Week 232 Responders (n = 204)	125 participants	—
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 Week 244 Responders (n = 187)	111 participants	—
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 Week 260 Responders (n = 125)	86 participants	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 310)	62 participants	—
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 Week 24 Responders (n = 298)	74 participants	—
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 Week 52 Responders (n = 282)	91 participants	—
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 Week 76 Responders (n = 269)	99 participants	—
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 Week 104 Responders (n = 261)	102 participants	—
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 Week 128 Responders (n = 242)	98 participants	—
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 Week 156 Responders (n = 234)	97 participants	—
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 Week 180 Responders (n = 226)	90 participants	—
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 Week 208 Responders (n = 217)	93 participants	—
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 Week 220 Responders (n = 210)	87 participants	—
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 Week 232 Responders (n = 204)	89 participants	—
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 Week 244 Responders (n = 187)	88 participants	—
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 Week 260 Responders (n = 125)	69 participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 309)	-25.24 mm Standard Deviation 28.029	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 297)	-31.07 mm Standard Deviation 27.663	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 281)	-33.62 mm Standard Deviation 27.803	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 268)	-36.58 mm Standard Deviation 27.425	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 260)	-37.21 mm Standard Deviation 29.090	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 241)	-38.10 mm Standard Deviation 28.778	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 233)	-39.11 mm Standard Deviation 28.510	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 225)	-40.30 mm Standard Deviation 26.378	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 216)	-39.87 mm Standard Deviation 28.222	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n = 209)	-40.44 mm Standard Deviation 27.913	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 203)	-40.69 mm Standard Deviation 27.205	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n = 186)	-41.19 mm Standard Deviation 26.962	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 124)	-45.50 mm Standard Deviation 24.849	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 309)	192 participants	—
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 Week 24 Responders (n = 297)	214 participants	—
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 Week 52 Responders (n = 281)	213 participants	—
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 Week 76 Responders (n = 268)	211 participants	—
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 Week 104 Responders (n = 260)	201 participants	—
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 Week 128 Responders (n = 241)	185 participants	—
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 Week 156 Responders (n = 233)	184 participants	—
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 Week 180 Responders (n = 225)	184 participants	—
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 Week 208 Responders (n = 216)	179 participants	—
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 Week 220 Responders (n = 209)	175 participants	—
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 Week 232 Responders (n = 203)	168 participants	—
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 Week 244 Responders (n = 186)	160 participants	—
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 Week 260 Responders (n = 124)	112 participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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).

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 310)	-16.12 mm Standard Deviation 19.369	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 298)	-20.45 mm Standard Deviation 19.831	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 282)	-22.94 mm Standard Deviation 21.005	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 269)	-25.13 mm Standard Deviation 21.087	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 261)	-26.24 mm Standard Deviation 22.391	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 242)	-26.52 mm Standard Deviation 21.811	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 234)	-27.24 mm Standard Deviation 22.802	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 226)	-28.35 mm Standard Deviation 21.745	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 217)	-27.92 mm Standard Deviation 21.656	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n = 210)	-27.70 mm Standard Deviation 22.216	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 205)	-28.30 mm Standard Deviation 22.418	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n = 187)	-29.33 mm Standard Deviation 21.612	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 125)	-31.44 mm Standard Deviation 20.508	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 310)	170 participants	—
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 Week 24 Responders (n = 298)	190 participants	—
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 Week 52 Responders (n = 282)	186 participants	—
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 Week 76 Responders (n = 269)	188 participants	—
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 Week 104 Responders (n = 261)	189 participants	—
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 Week 128 Responders (n = 242)	179 participants	—
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 Week 156 Responders (n = 234)	175 participants	—
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 Week 180 Responders (n = 226)	177 participants	—
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 Week 208 Responders (n = 217)	167 participants	—
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 Week 220 Responders (n = 210)	160 participants	—
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 Week 232 Responders (n = 205)	159 participants	—
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 Week 244 Responders (n = 187)	148 participants	—
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 Week 260 Responders (n = 125)	103 participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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).

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 310)	-24.51 mm Standard Deviation 28.334	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 298)	-31.02 mm Standard Deviation 27.323	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 282)	-34.09 mm Standard Deviation 28.646	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 269)	-36.55 mm Standard Deviation 26.897	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 261)	-37.34 mm Standard Deviation 29.839	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 242)	-38.15 mm Standard Deviation 29.172	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 234)	-38.43 mm Standard Deviation 28.667	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 226)	-39.40 mm Standard Deviation 27.830	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 217)	-37.93 mm Standard Deviation 30.306	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n = 210)	-39.30 mm Standard Deviation 28.996	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 204)	-40.31 mm Standard Deviation 29.449	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n = 187)	-41.66 mm Standard Deviation 29.196	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 125)	-47.83 mm Standard Deviation 24.636	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 310)	181 participants	—
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 Week 24 Responders (n = 298)	210 participants	—
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 Week 52 Responders (n = 282)	208 participants	—
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 Week 76 Responders (n = 269)	204 participants	—
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 Week 104 Responders (n = 261)	199 participants	—
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 Week 128 Responders (n = 242)	188 participants	—
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 Week 156 Responders (n = 234)	178 participants	—
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 Week 180 Responders (n = 226)	186 participants	—
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 Week 208 Responders (n = 217)	172 participants	—
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 Week 220 Responders (n = 210)	165 participants	—
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 Week 232 Responders (n = 204)	164 participants	—
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 Week 244 Responders (n = 187)	157 participants	—
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 Week 260 Responders (n = 125)	111 participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 226)	-4.24 cm Standard Deviation 2.664	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 310)	-2.82 cm Standard Deviation 2.700	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 298)	-3.48 cm Standard Deviation 2.640	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 282)	-3.80 cm Standard Deviation 2.743	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 269)	-3.98 cm Standard Deviation 2.674	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 261)	-4.12 cm Standard Deviation 2.780	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 242)	-4.04 cm Standard Deviation 2.754	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 234)	-3.93 cm Standard Deviation 3.978	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 217)	-4.27 cm Standard Deviation 2.677	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n = 210)	-4.29 cm Standard Deviation 2.677	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 205)	-4.30 cm Standard Deviation 2.700	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n = 186)	-4.56 cm Standard Deviation 2.610	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 124)	-4.94 cm Standard Deviation 2.470	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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. 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 \[very severe\].

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 232 Responders (n = 205)	176 participants	—
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 Week 244 Responders (n = 186)	165 participants	—
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 Week 260 Responders (n = 124)	114 participants	—
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 Week 12 Responders (n = 310)	198 participants	—
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 Week 24 Responders (n = 298)	231 participants	—
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 Week 52 Responders (n = 282)	224 participants	—
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 Week 76 Responders (n = 269)	221 participants	—
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 Week 104 Responders (n = 261)	215 participants	—
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 Week 128 Responders (n = 242)	230 participants	—
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 Week 156 Responders (n = 234)	192 participants	—
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 Week 180 Responders (n = 226)	191 participants	—
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 Week 208 Responders (n = 217)	191 participants	—
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 Week 220 Responders (n = 210)	182 participants	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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 (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).

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 310)	205 participants	—
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 Week 24 Responders (n = 298)	225 participants	—
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 Week 52 Responders (n = 282)	218 participants	—
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 Week 76 Responders (n = 269)	219 participants	—
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 Week 104 Responders (n = 261)	212 participants	—
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 Week 128 Responders (n = 242)	202 participants	—
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 Week 156 Responders (n = 234)	192 participants	—
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 Week 180 Responders (n = 226)	201 participants	—
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 Week 208 Responders (n = 217)	190 participants	—
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 Week 220 Responders (n = 210)	181 participants	—
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 Week 232 Responders (n = 205)	183 participants	—
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 Week 244 Responders (n = 187)	170 participants	—
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 Week 260 Responders (n = 124)	117 participants	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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 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).

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 310)	133 participants	—
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 Week 24 Responders (n = 298)	157 participants	—
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 Week 52 Responders (n = 282)	169 participants	—
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 Week 76 Responders (n = 269)	173 participants	—
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 Week 104 Responders (n = 261)	170 participants	—
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 Week 128 Responders (n = 242)	155 participants	—
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 Week 156 Responders (n = 234)	156 participants	—
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 Week 180 Responders (n = 226)	155 participants	—
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 Week 208 Responders (n = 217)	147 participants	—
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 Week 220 Responders (n = 210)	148 participants	—
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 Week 232 Responders (n = 205)	145 participants	—
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 Week 244 Responders (n = 187)	135 participants	—
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 Week 260 Responders (n = 124)	96 participants	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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 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).

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 310)	80 participants	—
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 Week 24 Responders (n = 298)	103 participants	—
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 Week 52 Responders (n = 282)	113 participants	—
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 Week 76 Responders (n = 269)	114 participants	—
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 Week 104 Responders (n = 261)	129 participants	—
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 Week 128 Responders (n = 242)	115 participants	—
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 Week 156 Responders (n = 234)	119 participants	—
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 Week 180 Responders (n = 226)	110 participants	—
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 Week 208 Responders (n = 217)	113 participants	—
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 Week 220 Responders (n = 210)	109 participants	—
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 Week 232 Responders (n = 205)	110 participants	—
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 Week 244 Responders (n = 187)	104 participants	—
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 Week 260 Responders (n = 124)	76 participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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).

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 310)	-2.38 cm Standard Deviation 2.377	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 298)	-2.90 cm Standard Deviation 2.418	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 282)	-3.16 cm Standard Deviation 2.547	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 269)	-3.38 cm Standard Deviation 2.384	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 261)	-3.54 cm Standard Deviation 2.519	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 242)	-3.53 cm Standard Deviation 2.421	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 234)	-3.45 cm Standard Deviation 3.491	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 226)	-3.79 cm Standard Deviation 2.349	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 217)	-3.78 cm Standard Deviation 2.352	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n = 210)	-3.73 cm Standard Deviation 2.350	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 205)	-3.79 cm Standard Deviation 2.395	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n = 187)	-4.08 cm Standard Deviation 2.248	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 124)	-4.44 cm Standard Deviation 2.227	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 224)	-1.54 mg/dL Standard Deviation 2.530	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 308)	-1.27 mg/dL Standard Deviation 2.092	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 294)	-1.24 mg/dL Standard Deviation 2.275	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 279)	-1.30 mg/dL Standard Deviation 2.221	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 264)	-1.35 mg/dL Standard Deviation 2.314	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 258)	-1.45 mg/dL Standard Deviation 2.333	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 238)	-1.36 mg/dL Standard Deviation 2.589	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 230)	-1.46 mg/dL Standard Deviation 2.604	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 215)	-1.54 mg/dL Standard Deviation 2.740	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n = 207)	-1.50 mg/dL Standard Deviation 2.956	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 203)	-1.57 mg/dL Standard Deviation 2.709	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n = 186)	-1.58 mg/dL Standard Deviation 2.748	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 123)	-1.67 mg/dL Standard Deviation 2.623	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 310)	115 participants	—
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 Week 24 Responders (n = 298)	144 participants	—
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 Week 52 Responders (n = 282)	143 participants	—
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 Week 76 Responders (n = 269)	157 participants	—
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 Week 104 Responders (n = 261)	155 participants	—
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 Week 128 Responders (n = 242)	140 participants	—
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 Week 156 Responders (n = 234)	147 participants	—
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 Week 180 Responders (n = 226)	143 participants	—
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 Week 208 Responders (n = 217)	131 participants	—
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 Week 220 Responders (n = 210)	134 participants	—
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 Week 232 Responders (n = 204)	134 participants	—
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 Week 244 Responders (n = 187)	118 participants	—
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 Week 260 Responders (n = 125)	88 participants	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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 \[CRP\]).

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 309)	145 participants	—
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 Week 24 Responders (n = 297)	184 participants	—
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 Week 52 Responders (n = 281)	169 participants	—
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 Week 76 Responders (n = 268)	179 participants	—
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 Week 104 Responders (n = 260)	177 participants	—
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 Week 128 Responders (n = 241)	159 participants	—
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 Week 156 Responders (n = 232)	157 participants	—
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 Week 180 Responders (n = 225)	160 participants	—
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 Week 208 Responders (n = 216)	152 participants	—
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 Week 220 Responders (n = 208)	148 participants	—
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 Week 232 Responders (n = 203)	144 participants	—
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 Week 244 Responders (n = 186)	132 participants	—
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 Week 260 Responders (n = 125)	95 participants	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
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 Week 12 Responders (n = 310)	62 participants	—
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 Week 24 Responders (n = 298)	75 participants	—
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 Week 52 Responders (n = 282)	94 participants	—
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 Week 76 Responders (n = 269)	101 participants	—
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 Week 104 Responders (n = 261)	100 participants	—
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 Week 128 Responders (n = 242)	97 participants	—
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 Week 156 Responders (n = 234)	96 participants	—
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 Week 180 Responders (n = 226)	87 participants	—
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 Week 208 Responders (n = 217)	86 participants	—
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 Week 220 Responders (n = 210)	78 participants	—
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 Week 232 Responders (n = 204)	96 participants	—
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 Week 244 Responders (n = 186)	74 participants	—
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 Week 260 Responders (n = 124)	63 participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 309)	-0.43 score on a scale Standard Deviation 1.313	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 294)	-0.60 score on a scale Standard Deviation 1.397	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 282)	-0.73 score on a scale Standard Deviation 1.375	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 268)	-0.77 score on a scale Standard Deviation 1.400	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 261)	-0.70 score on a scale Standard Deviation 1.502	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 242)	-0.67 score on a scale Standard Deviation 1.442	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 233)	-0.80 score on a scale Standard Deviation 1.472	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 225)	-0.70 score on a scale Standard Deviation 1.530	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 215)	-0.75 score on a scale Standard Deviation 1.535	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n = 208)	-0.74 score on a scale Standard Deviation 1.592	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 201)	-0.71 score on a scale Standard Deviation 1.579	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n = 187)	-0.68 score on a scale Standard Deviation 1.500	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 124)	-0.76 score on a scale Standard Deviation 1.521	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 12 (n = 277)	0.34 cm Standard Deviation 1.570	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 24 (n = 237)	0.25 cm Standard Deviation 1.445	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 52 (n = 234)	0.71 cm Standard Deviation 6.574	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 104 (n = 261)	0.59 cm Standard Deviation 1.632	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 128 (n = 199)	1.24 cm Standard Deviation 7.627	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 156 (n = 230)	0.58 cm Standard Deviation 1.722	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 180 (n = 184)	0.42 cm Standard Deviation 1.865	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 208 (n = 202)	0.96 cm Standard Deviation 5.877	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 220 (n = 61)	0.86 cm Standard Deviation 1.962	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 232 (n = 142)	0.60 cm Standard Deviation 2.657	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 244 (n = 61)	2.61 cm Standard Deviation 15.450	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ Week 260 (n = 123)	1.25 cm Standard Deviation 9.479	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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).

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 308)	-2.25 score on a scale Standard Deviation 5.888	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 294)	-2.97 score on a scale Standard Deviation 5.924	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 279)	-3.28 score on a scale Standard Deviation 5.908	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 226)	-3.27 score on a scale Standard Deviation 5.864	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 259)	-3.43 score on a scale Standard Deviation 6.560	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 201)	-3.18 score on a scale Standard Deviation 6.043	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 229)	-3.28 score on a scale Standard Deviation 6.154	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 184)	-3.44 score on a scale Standard Deviation 5.699	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 214)	-3.38 score on a scale Standard Deviation 6.070	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 170)	-3.25 score on a scale Standard Deviation 5.718	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 167)	-4.06 score on a scale Standard Deviation 6.528	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 12 Responders (n = 309)	-20.55 score on a scale Standard Deviation 22.143	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 24 Responders (n = 293)	-29.74 score on a scale Standard Deviation 24.558	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 52 Responders (n = 281)	-35.48 score on a scale Standard Deviation 25.949	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 76 Responders (n = 269)	-39.29 score on a scale Standard Deviation 25.817	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 104 Responders (n = 261)	-40.36 score on a scale Standard Deviation 27.532	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 128 Responders (n = 242)	-41.47 score on a scale Standard Deviation 26.244	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 156 Responders (n = 234)	-40.66 score on a scale Standard Deviation 26.834	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 180 Responders (n = 226)	-42.59 score on a scale Standard Deviation 25.816	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 208 Responders (n = 217)	-42.21 score on a scale Standard Deviation 26.698	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 220 Responders (n = 209)	-41.85 score on a scale Standard Deviation 26.493	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 232 Responders (n = 205)	-41.59 score on a scale Standard Deviation 26.898	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 244 Responders (n = 187)	-44.86 score on a scale Standard Deviation 25.016	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 260 Responders (n = 125)	-47.66 score on a scale Standard Deviation 24.845	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 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).

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 311)	-0.18 score on a scale Standard Deviation 3.280	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 295)	-0.40 score on a scale Standard Deviation 2.608	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 281)	-0.36 score on a scale Standard Deviation 3.360	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 231)	-0.59 score on a scale Standard Deviation 3.044	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 261)	-0.60 score on a scale Standard Deviation 3.723	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 200)	-0.79 score on a scale Standard Deviation 3.434	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 231)	-0.60 score on a scale Standard Deviation 3.446	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 187)	-0.69 score on a scale Standard Deviation 3.669	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 215)	-0.54 score on a scale Standard Deviation 4.412	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 170)	-0.74 score on a scale Standard Deviation 3.822	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 169)	-0.70 score on a scale Standard Deviation 3.863	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 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).

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 311)	-1.09 score on a scale Standard Deviation 5.193	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 295)	-1.41 score on a scale Standard Deviation 5.297	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 281)	-1.70 score on a scale Standard Deviation 6.330	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 231)	-1.87 score on a scale Standard Deviation 6.007	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 261)	-2.22 score on a scale Standard Deviation 6.816	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 202)	-2.16 score on a scale Standard Deviation 6.161	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 233)	-2.28 score on a scale Standard Deviation 5.361	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 187)	-2.88 score on a scale Standard Deviation 5.358	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 215)	-2.44 score on a scale Standard Deviation 5.270	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 171)	-2.76 score on a scale Standard Deviation 5.402	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 169)	-2.63 score on a scale Standard Deviation 6.348	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 12 Responders (n = 310)	-24.36 mm Standard Deviation 26.877	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 24 Responders (n = 297)	-29.69 mm Standard Deviation 27.662	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 52 Responders (n = 281)	-34.01 mm Standard Deviation 26.066	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 76 Responders (n = 267)	-37.16 mm Standard Deviation 23.291	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 104 Responders (n = 260)	-37.58 mm Standard Deviation 25.726	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 128 Responders (n = 239)	-38.17 mm Standard Deviation 26.787	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 156 Responders (n = 233)	-38.10 mm Standard Deviation 25.726	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 180 Responders (n = 225)	-39.76 mm Standard Deviation 23.903	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 208 Responders (n = 215)	-39.30 mm Standard Deviation 24.764	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 220 Responders (n = 209)	-39.44 mm Standard Deviation 24.361	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 232 Responders (n = 203)	-38.46 mm Standard Deviation 25.529	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 244 Responders (n = 186)	-43.14 mm Standard Deviation 22.824	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 260 Responders (n = 124)	-43.83 mm Standard Deviation 19.383	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n = 309)	-24.29 mm Standard Deviation 29.281	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n = 297)	-30.85 mm Standard Deviation 28.473	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n = 281)	-33.91 mm Standard Deviation 30.280	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n = 268)	-37.17 mm Standard Deviation 27.931	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n = 260)	-36.71 mm Standard Deviation 30.261	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n = 241)	-37.52 mm Standard Deviation 30.796	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n = 233)	-37.33 mm Standard Deviation 29.194	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n = 225)	-38.68 mm Standard Deviation 29.810	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n = 216)	-37.62 mm Standard Deviation 30.925	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n = 209)	-38.43 mm Standard Deviation 30.946	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n = 203)	-39.53 mm Standard Deviation 30.433	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n = 186)	-40.73 mm Standard Deviation 30.098	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n = 124)	-45.19 mm Standard Deviation 26.944	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 12 (n = 278)	6.92 score on a scale Standard Deviation 8.764	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 24 (n = 237)	7.30 score on a scale Standard Deviation 8.678	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 52 (n = 278)	9.07 score on a scale Standard Deviation 9.629	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 76 (n = 227)	9.70 score on a scale Standard Deviation 9.812	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 104 (n = 256)	9.95 score on a scale Standard Deviation 10.646	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 128 (n = 196)	10.01 score on a scale Standard Deviation 10.394	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 156 (n = 230)	11.23 score on a scale Standard Deviation 9.998	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 180 (n = 184)	10.67 score on a scale Standard Deviation 9.918	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 208 (n = 214)	10.39 score on a scale Standard Deviation 10.214	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 232 (n = 168)	10.76 score on a scale Standard Deviation 9.892	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure Week 260 (n = 165)	11.83 score on a scale Standard Deviation 9.907	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 12 (n = 278)	178 participants	—
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 24 (n = 237)	162 participants	—
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 52 (n = 278)	198 participants	—
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 76 (n = 227)	166 participants	—
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 104 (n = 256)	194 participants	—
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 128 (n = 196)	141 participants	—
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 156 (n = 230)	186 participants	—
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 180 (n = 184)	138 participants	—
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 208 (n = 214)	156 participants	—
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 232 (n = 168)	130 participants	—
Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 260 (n = 165)	129 participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 12 (n = 278)	3.18 score on a scale Standard Deviation 11.114	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 24 (n = 237)	4.24 score on a scale Standard Deviation 9.757	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 52 (n = 278)	4.56 score on a scale Standard Deviation 10.404	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 76 (n = 227)	4.31 score on a scale Standard Deviation 10.907	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 104 (n = 256)	4.42 score on a scale Standard Deviation 11.466	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 128 (n = 196)	3.71 score on a scale Standard Deviation 10.519	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 156 (n = 230)	4.19 score on a scale Standard Deviation 11.551	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 180 (n = 184)	4.64 score on a scale Standard Deviation 11.056	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 208 (n = 214)	5.50 score on a scale Standard Deviation 10.760	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 232 (n = 168)	4.66 score on a scale Standard Deviation 10.131	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure Week 260 (n = 165)	5.74 score on a scale Standard Deviation 10.758	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 12 (n = 278)	132 participants	—
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 24 (n = 237)	121 participants	—
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 52 (n = 278)	137 participants	—
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 76 (n = 227)	120 participants	—
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 104 (n = 256)	132 participants	—
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 128 (n = 196)	100 participants	—
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 156 (n = 230)	115 participants	—
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 180 (n = 184)	94 participants	—
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 208 (n = 214)	116 participants	—
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 232 (n = 168)	88 participants	—
Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure Week 260 (n = 165)	97 participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 24 (n = 303)	0.18 score on a scale Standard Deviation 0.245	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 52 (n = 239)	0.20 score on a scale Standard Deviation 0.258	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 104 (n = 263)	0.20 score on a scale Standard Deviation 0.258	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 128 (n = 201)	0.20 score on a scale Standard Deviation 0.245	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 156 (n = 232)	0.22 score on a scale Standard Deviation 0.274	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 180 (n = 187)	0.22 score on a scale Standard Deviation 0.245	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 208 (n = 216)	0.22 score on a scale Standard Deviation 0.244	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 232 (n = 171)	0.23 score on a scale Standard Deviation 0.247	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 260 (n = 166)	0.26 score on a scale Standard Deviation 0.244	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 12 (n = 284)	-3.26 score on a scale Standard Deviation 4.144	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 24 (n = 242)	-3.69 score on a scale Standard Deviation 4.081	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 52 (n = 281)	-4.29 score on a scale Standard Deviation 4.475	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 76 (n = 232)	-4.36 score on a scale Standard Deviation 4.383	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 104 (n = 261)	-4.80 score on a scale Standard Deviation 4.497	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 128 (n = 202)	-4.59 score on a scale Standard Deviation 4.501	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 156 (n = 233)	-5.05 score on a scale Standard Deviation 4.630	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 180 (n = 186)	-4.95 score on a scale Standard Deviation 4.526	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 208 (n = 217)	-5.18 score on a scale Standard Deviation 4.406	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 232 (n = 173)	-5.09 score on a scale Standard Deviation 4.052	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 260 (n = 169)	-5.66 score on a scale Standard Deviation 4.188	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260

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.

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 12 (n = 284)	176 participants	—
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 24 (n = 242)	160 participants	—
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 52 (n = 281)	204 participants	—
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 76 (n = 232)	170 participants	—
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 104 (n = 261)	198 participants	—
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 128 (n = 202)	151 participants	—
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 156 (n = 233)	179 participants	—
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 180 (n = 186)	144 participants	—
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 208 (n = 217)	169 participants	—
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 232 (n = 173)	139 participants	—
Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure Week 260 (n = 169)	142 participants	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260

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?

Outcome measures

Outcome measures
Measure	Adalimumab n=311 Participants Subjects on active treatment received SC injection of 40 mg adalimumab every other week.	Placebo Subjects on placebo treatment received SC injection of matched placebo every other week.
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 12 (n = 310)	140 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 24 (n = 298)	153 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 52 (n = 282)	164 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 76 (n = 269)	162 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 104 (n = 259)	172 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 128 (n = 194)	124 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 156 (n = 230)	161 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 180 (n = 185)	127 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 208 (n = 212)	144 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 232 (n = 172)	122 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 260 (n = 165)	112 participants	—

Adverse Events

Any Adalimumab

Serious events: 96 serious events

Other events: 279 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Any Adalimumab n=311 participants at risk By duration of exposure to any adalimumab 40 mg eow, subcutaneous
Cardiac disorders Aortic valve incompetence	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Cardiac disorders Arteriosclerosis coronary artery	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Cardiac disorders Atrial fibrillation	0.96% 3/311 • Baseline through 260 weeks of adalimumab exposure
Cardiac disorders Atrial flutter	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Cardiac disorders Conduction disorder	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Cardiac disorders Coronary artery disease	0.96% 3/311 • Baseline through 260 weeks of adalimumab exposure
Cardiac disorders Myocardial infarction	1.3% 4/311 • Baseline through 260 weeks of adalimumab exposure
Cardiac disorders Supraventricular tachycardia	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Ear and labyrinth disorders Inner ear disorder	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Endocrine disorders Goitre	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Eye disorders Ulcerative keratitis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Abdominal hernia	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Colitis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Crohn's disease	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Diarrhoea	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Diverticular perforation	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Enterocele	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Inguinal hernia	0.64% 2/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Intestinal obstruction	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Intestinal polyp	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Oesophageal hypomotility	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Oesophageal rupture	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Pancreatitis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Umbilical hernia	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
General disorders Chest pain	1.6% 5/311 • Baseline through 260 weeks of adalimumab exposure
General disorders Injection site reaction	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
General disorders Non-cardiac chest pain	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
General disorders Pyrexia	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Hepatobiliary disorders Cholecystitis chronic	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Immune system disorders Drug hypersensitivity	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Appendicitis	0.64% 2/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Beta haemolytic streptococcal infection	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Cellullitis	0.96% 3/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Endocarditis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Escherichia infection	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Gastroenteritis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Perirectal abscess	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Pharyngitis	0.64% 2/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Pneumonia	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Pyelonephritis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Rectal abscess	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Respiratory tract infection	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Staphylococcal abscess	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Device failure	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Electric shock	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Head injury	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Injury	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Joint injury	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Ligament injury	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Ligament rupture	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Meniscus lesion	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Nerve injury	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Patella fracture	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Radius fracture	0.64% 2/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Stent occlusion	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Tendon rupture	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Tibia fracture	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Wrist fracture	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Investigations Hepatic enzyme increased	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Metabolism and nutrition disorders Dehydration	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Metabolism and nutrition disorders Hypoglycaemia	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Metabolism and nutrition disorders Hypovitaminosis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	1.3% 4/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Arthritis	0.64% 2/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Back pain	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Costochondritis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Lupus-like syndrome	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Myopathy	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Osteoarthritis	0.64% 2/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Pain in extremity	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Periathritis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Sacroiliitis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer Stage I	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Nervous system disorders Cerebral infarction	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Nervous system disorders Cerebrovascular accident	0.64% 2/311 • Baseline through 260 weeks of adalimumab exposure
Nervous system disorders Convulsion	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Nervous system disorders Grand mal convulsion	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Nervous system disorders Intracranial venous sinus thrombosis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Psychiatric disorders Depression	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Renal and urinary disorders Nephrolithiasis	0.64% 2/311 • Baseline through 260 weeks of adalimumab exposure
Reproductive system and breast disorders Breast enlargement	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Reproductive system and breast disorders Endometrial hyperplasia	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Reproductive system and breast disorders Ovarian cyst	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Reproductive system and breast disorders Rectocele	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Cough	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Haemothorax	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Pleural adhesion	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.64% 2/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Skin and subcutaneous tissue disorders Psoriasis	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Skin and subcutaneous tissue disorders Urticaria	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Surgical and medical procedures Abortion induced	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Vascular disorders Hypertension	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure
Vascular disorders Venous insufficiency	0.32% 1/311 • Baseline through 260 weeks of adalimumab exposure

Other adverse events

Other adverse events
Measure	Any Adalimumab n=311 participants at risk By duration of exposure to any adalimumab 40 mg eow, subcutaneous
Eye disorders Iritis	5.1% 16/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Abdominal pain upper	6.4% 20/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Diarrhoea	13.2% 41/311 • Baseline through 260 weeks of adalimumab exposure
Gastrointestinal disorders Nausea	9.6% 30/311 • Baseline through 260 weeks of adalimumab exposure
General disorders Fatigue	11.9% 37/311 • Baseline through 260 weeks of adalimumab exposure
General disorders Injection site reaction	5.1% 16/311 • Baseline through 260 weeks of adalimumab exposure
General disorders Oedema peripheral	6.1% 19/311 • Baseline through 260 weeks of adalimumab exposure
General disorders Pain	5.8% 18/311 • Baseline through 260 weeks of adalimumab exposure
General disorders Pyrexia	8.7% 27/311 • Baseline through 260 weeks of adalimumab exposure
Immune system disorders Seasonal allergy	6.1% 19/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Bronchitis	13.2% 41/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Gastroenteritis	5.5% 17/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Influenza	12.2% 38/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Nasopharyngitis	35.4% 110/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Pharyngitis	7.4% 23/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Rhinitis	5.8% 18/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Sinusitis	15.1% 47/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Upper respiratory tract infection	24.8% 77/311 • Baseline through 260 weeks of adalimumab exposure
Infections and infestations Viral infection	9.0% 28/311 • Baseline through 260 weeks of adalimumab exposure
Injury, poisoning and procedural complications Contusion	5.8% 18/311 • Baseline through 260 weeks of adalimumab exposure
Investigations Alanine aminotransferase increased	6.4% 20/311 • Baseline through 260 weeks of adalimumab exposure
Metabolism and nutrition disorders Hypercholesterolaemia	8.0% 25/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	24.1% 75/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Arthralgia	17.4% 54/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Back pain	12.2% 38/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Muscle spasms	6.1% 19/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.4% 20/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Myalgia	5.8% 18/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Osteoarthritis	5.5% 17/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 24/311 • Baseline through 260 weeks of adalimumab exposure
Musculoskeletal and connective tissue disorders Tendonitis	5.5% 17/311 • Baseline through 260 weeks of adalimumab exposure
Nervous system disorders Dizziness	7.1% 22/311 • Baseline through 260 weeks of adalimumab exposure
Nervous system disorders Headache	19.3% 60/311 • Baseline through 260 weeks of adalimumab exposure
Nervous system disorders Paraesthesia	5.5% 17/311 • Baseline through 260 weeks of adalimumab exposure
Psychiatric disorders Anxiety	6.4% 20/311 • Baseline through 260 weeks of adalimumab exposure
Psychiatric disorders Depression	7.1% 22/311 • Baseline through 260 weeks of adalimumab exposure
Psychiatric disorders Insomnia	7.7% 24/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Cough	14.1% 44/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.5% 17/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.9% 34/311 • Baseline through 260 weeks of adalimumab exposure
Respiratory, thoracic and mediastinal disorders Rhinorrhea	5.8% 18/311 • Baseline through 260 weeks of adalimumab exposure
Skin and subcutaneous tissue disorders Eczema	5.1% 16/311 • Baseline through 260 weeks of adalimumab exposure
Skin and subcutaneous tissue disorders Pruritus	6.1% 19/311 • Baseline through 260 weeks of adalimumab exposure
Skin and subcutaneous tissue disorders Psoriasis	5.1% 16/311 • Baseline through 260 weeks of adalimumab exposure
Skin and subcutaneous tissue disorders Rash	8.7% 27/311 • Baseline through 260 weeks of adalimumab exposure
Vascular disorders Hypertension	14.5% 45/311 • Baseline through 260 weeks of adalimumab exposure

Additional Information

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