Trial Outcomes & Findings for Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis (NCT NCT00195819)

NCT ID: NCT00195819

Last Updated: 2011-06-28

Results Overview

ASAS 20 responders - improvement of \>=20% and absolute improvement of \>=10 units from Baseline in a visual analog scale (VAS) 0 \[no disease activity\]-100 \[high disease activity\]) 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 \[severe\]), BAth Ankylosing Spondylitis Functional Index (BASFI) VAS (0 \[easy \]-100\[impossible\]); and Inflammation VAS; (1 \[no pain\] to 10 \[severe pain\]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 82 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2011-06-28

Participant Flow

The placebo group included subjects who were randomized to placebo even if they received early escape open label adalimumab. The adalimumab exposure group included subjects who were randomized to blinded adalimumab.

Participant milestones

Measure	Placebo 40 mg Every Other Week (Eow), Subcutaneous (SC)	Any Adalimumab 40 mg every other week (eow), subcutaneous (SC)
Double-Blind STARTED	44	38
Double-Blind COMPLETED	42	38
Double-Blind NOT COMPLETED	2	0
Open-label STARTED	0	82
Open-label COMPLETED	0	62
Open-label NOT COMPLETED	0	20

Reasons for withdrawal

Measure	Placebo 40 mg Every Other Week (Eow), Subcutaneous (SC)	Any Adalimumab 40 mg every other week (eow), subcutaneous (SC)
Double-Blind Withdrawal by Subject	1	0
Double-Blind Moved	1	0
Open-label Adverse Event	0	9
Open-label Lack of Efficacy	0	2
Open-label Pregnancy	0	1
Open-label Protocol Violation	0	2
Open-label Moved	0	1
Open-label Withdrawal by Subject	0	5

Baseline Characteristics

Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis

Baseline characteristics by cohort

Measure	Adalimumab n=82 Participants By duration of exposure to any adalimumab 40 mg eow, subcutaneous
Age Continuous <=40 years	35 participants n=5 Participants
Age Continuous Between 40 and 65 years	45 participants n=5 Participants
Age Continuous >=65 years	2 participants n=5 Participants
Age Continuous	40.9 years STANDARD_DEVIATION 10.97 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants
Region of Enrollment Canada	82 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full analysis set - includes all subjects who were randomized and received at least one injection of study medication. The full analysis set was analyzed by treatment group.

ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 0 [no disease activity]-100 [high disease activity]) 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]), BAth Ankylosing Spondylitis Functional Index (BASFI) VAS (0 [easy ]-100[impossible]); and Inflammation VAS; (1 [no pain] to 10 [severe pain]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.

Outcome measures

Measure	Adalimumab n=38 Participants 40 mg every other week, subcutaneous	Placebo n=44 Participants 40 mg every other week, subcutaneous
Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 Responder	18 participants	12 participants
Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 Non-responder	20 participants	32 participants
Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 Missing	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline and 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

Measure	Adalimumab n=70 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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	—
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 M03-606 (N=70)	0.5 score on a scale Standard Error 0.36	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be 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) 0 [no disease activity]-100 [high disease activity]) 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; (1 [no pain] to 10 [severe pain]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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=82)	48 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=80)	52 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=78)	60 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=74)	60 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=69)	53 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=62)	47 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=67)	53 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=64)	55 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=62)	50 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=54)	49 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=27)	24 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=75)	57 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=70)	57 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

ASAS 50 responders - improvement of >=50% and absolute improvement of >=20 units (0-100) from Baseline in visual analog scale (VAS) for >=3 of the 4 domains; Patient's Global Assessment of disease activity; (0[none]-100[severe]) VAS scale; Total Back Pain VAS; (0 [no pain]-100 [severe]); BASFI VAS; (0 [easy ]-100[impossible]) and Inflammation VAS; (1 [no pain] to 10 [severe pain]). In addition, absence of deterioration in the potential remaining domain. Applied to each scale and not overall global scale.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 12 Responders (n=82)	29 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 24 Responders (n=80)	38 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 52 Responders (n=78)	45 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 76 Responders (n=75)	46 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 104 Responders (n=74)	47 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 128 Responders (n=70)	46 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 156 Responders (n=69)	42 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 180 Responders (n=62)	38 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 208 Responders (n=67)	37 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 220 Responders (n=64)	42 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 232 Responders (n=62)	42 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 260 Responders (n=27)	24 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure Week 244 Responders (n=54)	40 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

ASAS 70 responders - improvement of >=70% and absolute improvement of >=30 units (0-100) from Baseline in visual analog scale (VAS) for >=3 of the 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; 1 [no pain] to 10 [severe pain]). In addition, absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 12 Responders (n=82)	18 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 24 Responders (n=80)	27 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 52 Responders (n=78)	32 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 76 Responders (n=75)	34 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 104 Responders (n=74)	35 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 128 Responders (n=70)	32 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 156 Responders (n=69)	31 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 180 Responders (n=62)	24 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 208 Responders (n=67)	28 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 220 Responders (n=64)	26 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 232 Responders (n=62)	28 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 244 Responders (n=54)	29 participants	—
Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure Week 260 Responders (n=27)	14 participants	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-28.55 mm Standard Deviation 26.808	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-32.43 mm Standard Deviation 29.047	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-38.67 mm Standard Deviation 26.255	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=75)	-40.85 mm Standard Deviation 25.934	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-42.72 mm Standard Deviation 24.263	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=70)	-40.99 mm Standard Deviation 27.741	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	-40.86 mm Standard Deviation 27.203	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-41.74 mm Standard Deviation 26.622	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	-40.79 mm Standard Deviation 26.049	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	-43.41 mm Standard Deviation 23.854	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=62)	-42.77 mm Standard Deviation 29.574	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=54)	-51.02 mm Standard Deviation 23.297	—
Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-51.26 mm Standard Deviation 18.451	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mmg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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 Responder (n=62)	52 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 Responder (n=27)	26 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 12 Responder (n=82)	53 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 Responder (n=80)	56 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 Responder (n=78)	61 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 Responder (n=75)	59 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 Responder (n=74)	64 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 Responder (n=70)	57 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 Responder (n=69)	57 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 Responder (n=67)	56 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 Responder (n=64)	57 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 Responder (n=62)	53 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 Responder (n=54)	50 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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 10 cm 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 10 (impossible).

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=75)	-30.42 mm Standard Deviation 24.607	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	-30.12 mm Standard Deviation 24.437	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	-29.81 mm Standard Deviation 23.976	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=62)	-31.35 mm Standard Deviation 22.964	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=54)	-36.65 mm Standard Deviation 21.847	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-30.83 mm Standard Deviation 22.174	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-19.83 mm Standard Deviation 23.481	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-24.39 mm Standard Deviation 23.559	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-27.83 mm Standard Deviation 25.325	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-30.51 mm Standard Deviation 23.382	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=70)	-30.67 mm Standard Deviation 24.209	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-28.76 mm Standard Deviation 24.060	—
Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	-30.47 mm Standard Deviation 23.333	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 76 Responder (n-75)	55 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 104 Responder (n=74)	55 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 180 Responder (n=62)	45 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 232 Responder (n=62)	48 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 12 Responder (n=82)	46 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 24 Responder (n=80)	52 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 52 Responder (n=78)	53 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 128 Responder (n=70)	51 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 156 Responder (n=69)	50 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 208 Responder (n=67)	51 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 220 Responder (n=64)	47 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 244 Responder (n=54)	46 participants	—
BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 260 Responder (n=27)	22 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=62)	-42.56 mm Standard Deviation 27.844	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=54)	-50.30 mm Standard Deviation 23.936	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-29.30 mm Standard Deviation 26.783	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-31.89 mm Standard Deviation 29.675	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-39.46 mm Standard Deviation 26.658	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=75)	-40.89 mm Standard Deviation 26.375	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-43.85 mm Standard Deviation 24.730	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=70)	-44.07 mm Standard Deviation 25.944	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	-42.67 mm Standard Deviation 27.257	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-41.06 mm Standard Deviation 28.604	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	-42.16 mm Standard Deviation 27.092	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	-43.77 mm Standard Deviation 25.228	—
Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-49.41 mm Standard Deviation 27.025	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 52, 76, 128, 152, 180, 208, 220, 232, 244, and 260

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 52 Responder (n=78)	66 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 76 Responder (n=75)	62 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 104 Responder (n=74)	64 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 12 Responder (n=82)	56 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 24 Responder (n=80)	57 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 128 Responder (n=70)	62 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 156 Responder (n=69)	59 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 180 Responder (n=62)	50 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 208 Responder (n=67)	56 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 220 Responder (n=64)	59 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 232 Responder (n=62)	52 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 244 Responder (n=54)	53 participants	—
Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure Week 260 Responder (n=27)	25 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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) of 0 (none) to 10 (very severe). A decrease in inflammation represents improvement.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	-4.25 cm Standard Deviation 2.690	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-4.21 cm Standard Deviation 2.522	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	-4.22 cm Standard Deviation 2.553	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-2.79 cm Standard Deviation 2.650	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-3.29 cm Standard Deviation 2.882	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-3.89 cm Standard Deviation 2.663	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=75)	-4.12 cm Standard Deviation 2.480	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-4.50 cm Standard Deviation 2.465	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=70)	-4.32 cm Standard Deviation 2.512	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	-4.48 cm Standard Deviation 2.442	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=62)	-4.51 cm Standard Deviation 2.786	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=54)	-4.96 cm Standard Deviation 2.357	—
Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-5.21 cm Standard Deviation 2.375	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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 in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 [none] to 10 [very severe].

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 52 Responder (n=78)	66 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 76 Responder (n=75)	64 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 128 Responder (n=70)	61 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 156 Responder (n=69)	55 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 180 Responder (n=62)	53 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 208 Responder (n=67)	58 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 220 Responder (n=64)	57 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 232 Responder (n=62)	53 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 244 Responder (n=54)	49 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 12 Responder (n=82)	52 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 24 Responder (n=80)	59 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 104 Responder (n=74)	65 particpants	—
Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure Week 260 Responder (n=27)	25 particpants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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 100(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:

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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=80)	61 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=78)	64 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 12 Responders (n=82)	61 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=75)	64 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=74)	65 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=70)	60 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=69)	59 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=62)	55 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=67)	61 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=64)	58 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=62)	57 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=54)	51 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=27)	26 Participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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 100 (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:

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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=54)	42 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=67)	46 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=64)	48 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=62)	47 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=80)	41 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=78)	48 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=75)	52 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=74)	52 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=70)	45 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=69)	51 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=62)	43 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 12 Responders (n=82)	32 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=27)	25 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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 100 (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:

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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=80)	32 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=27)	14 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 12 Responders (n=82)	24 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=78)	34 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=75)	37 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=74)	35 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=70)	37 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=69)	34 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=62)	28 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=67)	35 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=64)	31 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=62)	35 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=54)	30 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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 100 (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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-3.60 cm Standard Deviation 2.338	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-2.48 cm Standard Deviation 2.305	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-2.96 cm Standard Deviation 2.694	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-3.41 cm Standard Deviation 2.511	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=75)	-3.70 cm Standard Deviation 2.486	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-3.83 cm Standard Deviation 2.392	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=70)	-3.64 cm Standard Deviation 2.536	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	-3.63 cm Standard Deviation 2.583	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	-3.70 cm Standard Deviation 2.367	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	-3.83 cm Standard Deviation 2.384	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=62)	-3.80 cm Standard Deviation 2.538	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=54)	-4.36 cm Standard Deviation 2.214	—
Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-4.48 cm Standard Deviation 2.011	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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 indicate reduction in inflammation. A decrease in CRP indicates improvement.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-1.81 mg/dL Standard Deviation 2.824	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-1.99 mg/dL Standard Deviation 2.995	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	-2.00 mg/dL Standard Deviation 3.117	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-1.81 mg/dL Standard Deviation 2.782	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-1.60 mg/dL Standard Deviation 3.581	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=75)	-1.86 mg/dL Standard Deviation 2.897	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-1.90 mg/dL Standard Deviation 2.850	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=70)	-1.92 mg/dL Standard Deviation 3.028	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	-1.83 mg/dL Standard Deviation 3.060	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	-1.89 mg/dL Standard Deviation 3.063	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=62)	-1.67 mg/dL Standard Deviation 3.267	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=54)	-2.07 mg/dL Standard Deviation 3.252	—
Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-1.27 mg/dL Standard Deviation 1.513	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

ASAS 40 responder: improvement of >= 40% and absolute improvement of >= 20 units (on a scale of 0 to 100) in >= 3 of the 4 domains: Patient global assessment (VAS score [0-100 scale]); Pain (Total Back Pain VAS score 0-100 scale); Function (BASFI score 0-100 scale); Inflammation (the mean of the two morning stiffness-related BASDAI VAS scores (i.e. the average of items 5 and 6 of the BASDAI. Applied to each scale. In addition, absence of deterioration in the potential remaining domain, where deterioration is defined as a net worsening of > 0 units (on a scale of 0 to 100).

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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=82)	34 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=69)	45 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=80)	41 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=78)	48 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=75)	50 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=74)	52 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=70)	47 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=62)	40 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=67)	44 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=64)	48 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=62)	45 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=54)	42 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=27)	22 participants	—

SECONDARY outcome

Timeframe: Weeks 12, 16, 20, 24, 30, 36, 42, 48, 52, 64, 76, 88, 104, 116, 128, 140, 156, 168, 180, 192, 208, 220, 232, 244, and 260

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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=75)	57 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=69)	51 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=27)	22 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 12 Responders (n=82)	45 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=80)	49 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=78)	55 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=74)	56 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=70)	53 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=62)	45 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=67)	48 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=64)	47 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=62)	49 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=54)	42 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

Evaluation of the mean changes in BASDAI in subjects with adalimumab exposure from Baseline through 5 years for the effect of adalimumab on structural damage. 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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 24 Responders (n=80)	25 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 180 Responders (n=62)	29 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 12 Responders (n=82)	23 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 52 Responders (n=78)	31 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 76 Responders (n=75)	33 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 104 Responders (n=74)	35 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 128 Responders (n=70)	31 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 156 Responders (n=69)	28 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 208 Responders (n=67)	32 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 220 Responders (n=64)	29 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 232 Responders (n=62)	34 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 244 Responders (n=54)	25 participants	—
Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 Week 260 Responders (n=27)	16 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=75)	-0.64 cm Standard Deviation 1.321	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=69)	-1.01 cm Standard Deviation 1.477	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week (156 (n=69)	-1.00 cm Standard Deviation 1.426	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-1.03 cm Standard Deviation 1.746	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	-1.04 cm Standard Deviation 1.628	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-0.42 cm Standard Deviation 1.124	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-0.50 cm Standard Deviation 1.146	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-0.61 cm Standard Deviation 1.492	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-0.78 cm Standard Deviation 1.550	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	-0.86 cm Standard Deviation 1.521	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=60)	-0.88 cm Standard Deviation 1.541	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=51)	-1.00 cm Standard Deviation 1.659	—
Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-0.70 cm Standard Deviation 1.325	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

The EDASMI is a composite spinal mobility index comprised of 4 measures: 1) cervical rotation, 2) lumbar side flexion, 3) chest expansion, and 4) hip internal rotation spread. A grade of 0-4 scoring system was developed for each of the measures. The sum of 4 items (range 0 to 16) provide the EDASMI score. Decrease in EDASMI represents improvement. All EDASMI measures were done with a simple tape measure and recorded in centimeters (cm) by a rheumatologist and a clinician nurse.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-1.76 cm Standard Deviation 3.227	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-1.11 cm Standard Deviation 1.990	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-1.16 cm Standard Deviation 2.143	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-1.47 cm Standard Deviation 2.408	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=75)	-1.24 cm Standard Deviation 2.357	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=69)	-1.59 cm Standard Deviation 3.124	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	-1.50 cm Standard Deviation 3.457	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	-1.41 cm Standard Deviation 3.705	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	-1.34 cm Standard Deviation 3.301	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=60)	-1.65 cm Standard Deviation 3.267	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=51)	-1.42 cm Standard Deviation 3.199	—
Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-1.56 cm Standard Deviation 3.566	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	0.66 cm Standard Deviation 1.803	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=75)	0.51 cm Standard Deviation 1.875	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=69)	0.60 cm Standard Deviation 2.287	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	0.49 cm Standard Deviation 1.881	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	0.60 cm Standard Deviation 2.252	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	0.46 cm Standard Deviation 2.013	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	0.47 cm Standard Deviation 1.907	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	0.66 cm Standard Deviation 1.717	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	0.57 cm Standard Deviation 1.960	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=60)	0.44 cm Standard Deviation 2.082	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=51)	0.39 cm Standard Deviation 2.074	—
Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	0.52 cm Standard Deviation 2.112	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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 (no tenderness) to 13 (severe tenderness).

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-2.26 Units on a scale Standard Deviation 5.335	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-3.66 Units on a scale Standard Deviation 5.253	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=52)	-3.52 Units on a scale Standard Deviation 5.207	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=50)	-3.72 Units on a scale Standard Deviation 4.887	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=66)	-4.11 Units on a scale Standard Deviation 5.114	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=48)	-3.81 Units on a scale Standard Deviation 5.640	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-3.26 Units on a scale Standard Deviation 4.608	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=77)	-3.61 Units on a scale Standard Deviation 5.573	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=59)	-3.56 Units on a scale Standard Deviation 5.392	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=67)	-3.27 Units on a scale Standard Deviation 5.224	—
Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=49)	-5.47 Units on a scale Standard Deviation 5.393	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

BAS-G consisted of two questions that asked the subject to indicate, on a 10 cm VAS, the effect the disease had on their well being over 1) last week, and 2) last 6 months. 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. The mean of the two scores give a BAS-G score of 0-10.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-45.05 mm Standard Deviation 22.934	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	-45.08 mm Standard Deviation 22.681	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	-46.73 mm Standard Deviation 21.367	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=62)	-45.56 mm Standard Deviation 23.453	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-23.41 mm Standard Deviation 20.456	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-32.78 mm Standard Deviation 23.638	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-39.40 mm Standard Deviation 23.975	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=75)	-42.63 mm Standard Deviation 23.133	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-44.78 mm Standard Deviation 22.845	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=70)	-43.28 mm Standard Deviation 25.578	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	-44.30 mm Standard Deviation 23.826	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=54)	-53.69 mm Standard Deviation 18.349	—
Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-50.93 mm Standard Deviation 18.478	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-0.29 score on scale Standard Deviation 4.171	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-1.00 score on scale Standard Deviation 4.792	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-1.45 score on scale Standard Deviation 4.497	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=59)	-0.92 score on scale Standard Deviation 4.427	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=51)	-0.81 score on scale Standard Deviation 5.789	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=70)	-0.04 score on scale Standard Deviation 2.592	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=68)	-1.26 score on scale Standard Deviation 5.231	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=50)	-1.38 score on scale Standard Deviation 4.453	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=66)	-1.29 score on scale Standard Deviation 5.737	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=48)	-0.33 score on scale Standard Deviation 2.300	—
Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=49)	-2.37 score on scale Standard Deviation 5.619	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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, Knee, Ankle, and Metatarsophalangeal (1-5).

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 12 (n=82)	-1.66 score on scale Standard Deviation 6.639	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 24 (n=80)	-2.36 score on scale Standard Deviation 6.582	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 52 (n=78)	-3.63 score on scale Standard Deviation 5.920	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 76 (n=59)	-3.34 score on scale Standard Deviation 7.184	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 104 (n=74)	-2.78 score on scale Standard Deviation 7.731	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 128 (n=52)	-3.10 score on scale Standard Deviation 6.307	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 156 (n=68)	-2.69 score on scale Standard Deviation 8.086	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 180 (n=50)	-2.90 score on scale Standard Deviation 7.833	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 208 (n=66)	-3.48 score on scale Standard Deviation 7.341	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 232 (n=48)	-3.23 score on scale Standard Deviation 7.197	—
Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure Week 260 (n=49)	-5.84 score on scale Standard Deviation 7.290	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

The physician will globally assess the subject's current disease state using a VAS scale with 0 being very good and 100 being very bad.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-38.68 mm Standard Deviation 24.745	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=75)	-38.21 mm Standard Deviation 24.570	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=70)	-42.26 mm Standard Deviation 23.083	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	-38.75 mm Standard Deviation 25.728	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-42.84 mm Standard Deviation 25.870	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=63)	-43.92 mm Standard Deviation 22.369	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=58)	-43.60 mm Standard Deviation 23.357	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-24.80 mm Standard Deviation 24.892	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-33.46 mm Standard Deviation 28.197	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-41.96 mm Standard Deviation 23.205	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=66)	-41.27 mm Standard Deviation 26.348	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=50)	-52.98 mm Standard Deviation 16.340	—
Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-50.33 mm Standard Deviation 19.958	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=82)	-25.49 mm Standard Deviation 29.566	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=80)	-28.08 mm Standard Deviation 31.414	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	-33.88 mm Standard Deviation 30.432	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=75)	-34.87 mm Standard Deviation 29.715	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=70)	-36.77 mm Standard Deviation 29.030	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	-37.07 mm Standard Deviation 28.661	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=69)	-34.91 mm Standard Deviation 30.125	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=62)	-33.50 mm Standard Deviation 30.180	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 208 (n=67)	-34.00 mm Standard Deviation 29.757	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 220 (n=64)	-35.33 mm Standard Deviation 28.620	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=62)	-34.11 mm Standard Deviation 30.186	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 244 (n=54)	-40.61 mm Standard Deviation 26.873	—
Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=27)	-33.41 mm Standard Deviation 30.147	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

The FACIT-Fatigue scale: overall score of 13 general questions divided into four primary Quality of Life (QoL) domains: 1) Physical Well-Being, 2) Social/Family Well-Being, 3) Emotional Well-Being, and 4) Functional Well-Being. For each question subject rates his/her condition for the past week on a 5-point scale ranging from 0 (not at all) to 4 (very much). The score ranges from 0 (highest level of fatigue) to 52 with 52 being the lowest level of fatigue.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 104 (n=74)	12.46 unit on a scale Standard Deviation 10.520	—
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 128 (n=52)	11.08 unit on a scale Standard Deviation 11.396	—
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 156 (n=68)	11.62 unit on a scale Standard Deviation 11.391	—
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 12 (n=74)	9.49 unit on a scale Standard Deviation 9.994	—
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 24 (n=53)	9.03 unit on a scale Standard Deviation 11.225	—
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 52 (n=78)	11.48 unit on a scale Standard Deviation 10.331	—
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 76 (n=59)	11.61 unit on a scale Standard Deviation 11.171	—
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 180 (n=50)	10.56 unit on a scale Standard Deviation 10.011	—
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 280 (n=66)	11.60 unit on a scale Standard Deviation 10.761	—
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 232 (n=48)	10.13 unit on a scale Standard Deviation 11.112	—
Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 Week 260 (n=49)	16.17 unit on a scale Standard Deviation 9.276	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

Change from Baseline in the SF-36 Health Survey Index completed by Subject to help subject keep track of how he/she was feeling and how well he/she was able to do usual activities. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicate improvement.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 208 (n=60)	12.42 score on scale Standard Deviation 9.925	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 232 (n=21)	10.88 score on scale Standard Deviation 10.401	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 12 (n=74)	7.60 score on scale Standard Deviation 8.320	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 24 (n=53)	9.26 score on scale Standard Deviation 9.389	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 52 (n=78)	10.63 score on scale Standard Deviation 8.982	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 76 (n=59)	11.26 score on scale Standard Deviation 8.685	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 104 (n=74)	11.29 score on scale Standard Deviation 9.668	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 128 (n=50)	11.76 score on scale Standard Deviation 8.868	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 156 (n=68)	11.73 score on scale Standard Deviation 9.726	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 180 (n=48)	10.74 score on scale Standard Deviation 10.781	—
Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure Week 260 (n=5)	12.19 score on scale Standard Deviation 8.410	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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 with MCID > 3 points. Minimal clinically important difference (MCID) for PCS was determined by a >= 3.0 point increase during exposure to adalimumab.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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 Responders (n=60)	49 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 12 Responders (n=74)	51 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 Responders (n=53)	41 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 Responders (n=21)	15 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 Responders (n=59)	50 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 Responders (n=78)	65 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 Responders (n=74)	61 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 Responders (n=50)	43 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 Responders (n=68)	56 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 Responders (n=48)	38 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 Responders (n=5)	4 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

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). Change from Baseline in the SF-36 Health Survey Index was completed by Subject. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 52 (n=78)	6.14 score on scale Standard Deviation 10.466	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 104 (n=74)	6.45 score on scale Standard Deviation 10.821	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 180 (n=48)	5.30 score on scale Standard Deviation 11.434	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 208 (n=60)	6.85 score on scale Standard Deviation 10.366	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 260 (n=5)	9.40 score on scale Standard Deviation 13.224	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 12 (n=74)	6.91 score on scale Standard Deviation 9.109	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 24 (n=53)	3.88 score on scale Standard Deviation 10.617	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 76 (n=59)	7.00 score on scale Standard Deviation 9.469	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 128 (n=50)	4.89 score on scale Standard Deviation 11.234	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 156 (n=68)	5.76 score on scale Standard Deviation 10.687	—
Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure Week 232 (n=21)	9.00 score on scale Standard Deviation 11.213	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

SF-36 is a standardized survey completed by Subject, 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 are subjects with MCID > 3 points. Minimal clinically important difference (MCID) for PCS was determined by a >= 3.0 point increase during exposure to adalimumab.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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 Responders (n=74)	49 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 Responders (n=78)	50 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 Responders (n=60)	41 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 Responders (n=21)	16 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 Responders (n=5)	4 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 Responders (n=53)	29 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 Responders (n=59)	39 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 Responders (n=74)	46 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 Responders (n=50)	30 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 Responders (n=68)	42 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 Responders (n=48)	27 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mmg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

Change from baseline in Health Utility Index Mark 3 (HUI-3) was reported. The HUI-3 is a generic approach to the measurement of health status and assessment of HRQL. The HUI-3 was comprised of two complementary components. The first component was a multi-attribute health status classification system that was used to describe health status. The second component was a multi-attribute utility function that was used to value health status as measured within the corresponding multi-attribute health status classification system. An increase in the HUI-3 score represents improvement.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 180 (n=49)	0.23 score on scale Standard Deviation 0.259	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 208 (n=65)	0.24 score on scale Standard Deviation 0.257	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 232 (n=47)	0.18 score on scale Standard Deviation 0.306	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 24 (n=81)	0.17 score on scale Standard Deviation 0.234	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 52 (n=62)	0.21 score on scale Standard Deviation 0.223	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 104 (n=74)	0.19 score on scale Standard Deviation 0.245	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 128 (n=47)	0.19 score on scale Standard Deviation 0.271	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 156 (n=62)	0.24 score on scale Standard Deviation 0.254	—
Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure Week 260 (n=48)	0.27 score on scale Standard Deviation 0.249	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. 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

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 12 (n=74)	-3.90 score on a scale Standard Deviation 4.556	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 24 (n=53)	-3.80 score on a scale Standard Deviation 4.993	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 208 (n=66)	-5.80 score on a scale Standard Deviation 5.127	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 232 (n=48)	-5.35 score on a scale Standard Deviation 5.538	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 160 (n=49)	-7.46 score on a scale Standard Deviation 4.811	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 52 (n=78)	-5.40 score on a scale Standard Deviation 4.724	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 76 (n=59)	-5.47 score on a scale Standard Deviation 4.830	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 104 (n=74)	-5.55 score on a scale Standard Deviation 4.593	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 128 (n=52)	-5.46 score on a scale Standard Deviation 4.741	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 156 (n=68)	-5.51 score on a scale Standard Deviation 5.015	—
Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure Week 180 (n=50)	-4.95 score on a scale Standard Deviation 5.415	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

ASQoL determined subject's quality of life comprised of 18 questions to be completed by the subject. Each statement on the ASQoL is given a score of "1" or "0." All item scores were summed to give a total score. 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 subjects with MCID <= -1.8 points. MCID was determined by a >= 1.8 score decrease during exposure to adalimumab.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
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 Responders (n=53)	27 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 Responders (n=59)	42 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 Responders (n=52)	41 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 Responders (n=66)	51 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 12 Responders (n=74)	48 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 Responders (n=78)	60 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 Responders (n=74)	59 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 Responders (n=68)	50 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 Responders (n=50)	37 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 Responders (n=48)	36 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 Responders (n=49)	43 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

Completed by subject at each visit. The MCIS was a patient reported outcome where the subjects 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? An increase in PASS indicates improvement.

During earlier weeks of the study PASS was measured/reported as minimal clinically important state (MCIS).

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 12 Responders (n=82)	35 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 24 Responders (n=80)	44 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 52 Responders (n=78)	50 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 156 Responders (n=68)	48 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 180 Responders (n=48)	32 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 76 Responders (n=75)	50 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 104 Responders (n=71)	49 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 128 Responders (n=51)	35 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 208 Responders (n=64)	42 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 232 Responders (n=47)	34 participants	—
Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure Week 260 Responders (n=46)	37 participants	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

Cartilage and bone degradation were assessed by evaluating changes in MMP-3. A decrease in MMP-3 represents improvement.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 180 (n=50)	-12.56 ng/mL Standard Deviation 36.045	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 208 (n=62)	-31.37 ng/mL Standard Deviation 115.467	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 220 (n=26)	-67.52 ng/mL Standard Deviation 169.992	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 232 (n=36)	-9.88 ng/mL Standard Deviation 24.293	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 260 (n=27)	-11.60 ng/mL Standard Deviation 25.776	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 12 (n=73)	-29.06 ng/mL Standard Deviation 98.960	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 24 (n=52)	-6.31 ng/mL Standard Deviation 20.115	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 52 (n=78)	-24.89 ng/mL Standard Deviation 97.671	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 76 (n=60)	-24.64 ng/mL Standard Deviation 102.536	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 104 (n=74)	-23.05 ng/mL Standard Deviation 94.471	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 128 (n=51)	-7.37 ng/mL Standard Deviation 21.704	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 156 (n=66)	-33.71 ng/mL Standard Deviation 115.252	—
Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 244 (n=27)	-67.88 ng/mL Standard Deviation 168.991	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

Cartilage and bone degradation were assessed by evaluating changes in CTX-II. A decrease in CTX-II represents improvement.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 12 (n=74)	-72.27 ng/mmolcr Standard Deviation 201.493	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 24 (n=52)	-39.87 ng/mmolcr Standard Deviation 173.995	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 52 (n=75)	-51.56 ng/mmolcr Standard Deviation 288.316	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 76 (n=58)	-89.93 ng/mmolcr Standard Deviation 324.185	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 104 (n=73)	-65.04 ng/mmolcr Standard Deviation 286.539	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 128 (n=51)	-96.53 ng/mmolcr Standard Deviation 293.026	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 156 (n=64)	-125.92 ng/mmolcr Standard Deviation 332.340	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 232 (n=35)	-113.54 ng/mmolcr Standard Deviation 354.684	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 244 (n=26)	-150.15 ng/mmolcr Standard Deviation 383.965	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 260 (n=24)	-141.42 ng/mmolcr Standard Deviation 411.224	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 180 (n=45)	-168.02 ng/mmolcr Standard Deviation 368.086	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 208 (n=55)	-172.18 ng/mmolcr Standard Deviation 350.006	—
Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 220 (n=26)	-175.42 ng/mmolcr Standard Deviation 387.357	—

SECONDARY outcome

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

Population: Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.

Cartilage degradation and bone resorption were assessed by evaluating changes in NTx. A decrease in NTx represents improvement.

Outcome measures

Measure	Adalimumab n=82 Participants 40 mg every other week, subcutaneous	Placebo 40 mg every other week, subcutaneous
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 76 (n=60)	-0.05 NM BCE Standard Deviation 5.735	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 104 (n=74)	-0.17 NM BCE Standard Deviation 3.891	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 260 (n=27)	-2.89 NM BCE Standard Deviation 2.903	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 12 (n=73)	0.63 NM BCE Standard Deviation 3.890	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 24 (n=53)	0.33 NM BCE Standard Deviation 3.857	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 52 (n=78)	-1.02 NM BCE Standard Deviation 4.539	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 128 (n=50)	-1.00 NM BCE Standard Deviation 4.414	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 156 (n=66)	-0.82 NM BCE Standard Deviation 3.749	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 180 (n=50)	0.52 NM BCE Standard Deviation 9.020	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 208 (n=62)	-1.94 NM BCE Standard Deviation 4.182	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 220 (n=26)	-3.10 NM BCE Standard Deviation 4.097	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 232 (n=36)	-1.47 NM BCE Standard Deviation 3.020	—
Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure Week 244 (n=27)	-4.59 NM BCE Standard Deviation 4.977	—

SECONDARY outcome

Timeframe: Week 12 and Week 52

Population: Intent-to-treat (ITT) - analysis of all subjects with at least one Baseline MRI were included in the ITT population.

The S.P.A.R.C.C. MRI index is a tool for scoring inflammation and structural damage in both the spine and sacroiliac (SI) joints. The spinal SPARCC index score consists of 3 subscales (edema, intense edema, and deep edema). Edema was defined as the presence of increased STIR signal in each of 4 Discovertebral unit (DVU) quadrants and was assigned a score (0 = normal signal, 1 = increased signal). The scoring of edema was repeated for each of 3 consecutive sagittal slices with a maximum score of 12 per DVU (range for edema, 0-72). The total spinal SPARCC index score is 0 to 108.

Outcome measures

Measure	Adalimumab n=38 Participants 40 mg every other week, subcutaneous	Placebo n=44 Participants 40 mg every other week, subcutaneous
Mean Change in Spinal Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure Week 12	-9.9 score on a scale Standard Error 1.01	-0.8 score on a scale Standard Error 0.94
Mean Change in Spinal Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure Week 52	-11.2 score on a scale Standard Error 1.08	-13.7 score on a scale Standard Error 1.03

SECONDARY outcome

Timeframe: Weeks 12 and 52

Population: Intent-to-treat (ITT) - analysis of all subjects with at least one Baseline MRI were included in the ITT population.

The S.P.A.R.C.C. MRI index is a tool for scoring inflammation and structural damage in both the spine and sacroiliac (SI) joints. The spinal SPARCC index score consists of 3 subscales (edema, intense edema, and deep edema). Edema was defined as the presence of increased STIR signal in each of 4 Discovertebral unit (DVU) quadrants and was assigned a score (0 = normal signal, 1 = increased signal). The scoring of edema was repeated for each of 3 consecutive sagittal slices with a maximum score of 12 per DVU (range for edema, 0-72). The total spinal SPARCC index score is 0 to 108.

Outcome measures

Measure	Adalimumab n=38 Participants 40 mg every other week, subcutaneous	Placebo n=44 Participants 40 mg every other week, subcutaneous
Mean Change in Sacroiliac (SI) Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure Week 12	-4.1 score on a scale Standard Error 0.64	-0.8 score on a scale Standard Error 0.60
Mean Change in Sacroiliac (SI) Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure Week 52	-5.4 score on a scale Standard Error 0.34	-5.5 score on a scale Standard Error 0.32

Adverse Events

Adalimumab

Serious events: 20 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab n=82 participants at risk By duration of exposure to any adalimumab 40 mg eow, subcutaneous
Eye disorders Diplopia	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Gastrointestinal disorders Diverticular perforation	2.4% 2/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Gastrointestinal disorders Peritonitis	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Gastrointestinal disorders Umbilical hernia	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Appendicitis	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Escherichia sepsis	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Gastroenteritis	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Pneumonia	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Pyelonephritis	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Injury, poisoning and procedural complications Foot fracture	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Injury, poisoning and procedural complications Injury	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Lupus-like syndrome	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.4% 2/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Synovial cyst	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign mesothelioma	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Psychiatric disorders Bipolar disorder	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Psychiatric disorders Psychotic disorders	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Surgical and medical procedures Abortion induced	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Vascular disorders Aortic aneurysm	1.2% 1/82 • Adverse event data were collected through Week 260 of adalimumab exposure.

Other adverse events

Measure	Adalimumab n=82 participants at risk By duration of exposure to any adalimumab 40 mg eow, subcutaneous
Eye disorders Iritis	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Gastrointestinal disorders Diarrhoea	8.5% 7/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Gastrointestinal disorders Dyspepsia	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Gastrointestinal disorders Nausea	12.2% 10/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Gastrointestinal disorders Vomiting	7.3% 6/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
General disorders Fatigue	15.9% 13/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
General disorders Injection Site Reaction	7.3% 6/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Bronchitis	8.5% 7/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Cellulitis	8.5% 7/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Gastroenteritis	8.5% 7/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Influenza	17.1% 14/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Nasopharyngitis	46.3% 38/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Sinusitis	9.8% 8/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Tooth Abscess	11.0% 9/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Upper Respiratory Tract Infection	40.2% 33/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Infections and infestations Urinary Tract Infection	7.3% 6/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Injury, poisoning and procedural complications Skin Laceration	7.3% 6/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Investigations Tuberculin Test Positive	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Metabolism and nutrition disorders Hypercholesterolaemia	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Ankylosing Spondylitis	24.4% 20/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Arthralgia	14.6% 12/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Back Pain	13.4% 11/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Bursitis	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Muscle Spasms	7.3% 6/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	9.8% 8/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Neck Pain	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Osteoarthritis	7.3% 6/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Pain in Extremity	12.2% 10/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Musculoskeletal and connective tissue disorders Tendonitis	7.3% 6/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Nervous system disorders Dizziness	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Nervous system disorders Headache	24.4% 20/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Psychiatric disorders Depression	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Renal and urinary disorders Nephrolithiasis	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	7.3% 6/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Skin and subcutaneous tissue disorders Dermatitis	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Skin and subcutaneous tissue disorders Eczema	8.5% 7/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Skin and subcutaneous tissue disorders Erythema	7.3% 6/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Skin and subcutaneous tissue disorders Urticaria	6.1% 5/82 • Adverse event data were collected through Week 260 of adalimumab exposure.
Vascular disorders Hypertension	7.3% 6/82 • Adverse event data were collected through Week 260 of adalimumab exposure.

Additional Information

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• Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
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Restriction type: OTHER