Trial Outcomes & Findings for A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment (NCT NCT02897115)

Last Updated: 2019-07-05

Results Overview

ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (C-reactive protein \[CRP\] or erythrocyte sedimentation rate \[ESR\]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." The percentage of participants with ASDAS inactive disease (defined as ASDAS \< 1.3) calculated using CRP is reported.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

Week 32

Results posted on

2019-07-05

Participant Flow

The study planned to enroll approximately 240 participants at 30 sites in Germany. Due to slow enrollment the study was terminated prematurely; at the time the decision to close the study was made 22 subjects were enrolled at 9 sites in Germany.

Participant milestones

Participant milestones
Measure	Treat-to-Target (T2T) Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) Participants received treatment as prescribed by their physician according to the local standard of care.
Overall Study STARTED	14	8
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Treat-to-Target (T2T) Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) Participants received treatment as prescribed by their physician according to the local standard of care.
Overall Study Early termination of study by sponsor	11	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.	Total n=22 Participants Total of all reporting groups
Age, Continuous	37.0 years STANDARD_DEVIATION 9.49 • n=14 Participants	29.6 years STANDARD_DEVIATION 7.96 • n=8 Participants	34.3 years STANDARD_DEVIATION 9.49 • n=22 Participants
Sex: Female, Male Female	8 Participants n=14 Participants	4 Participants n=8 Participants	12 Participants n=22 Participants
Sex: Female, Male Male	6 Participants n=14 Participants	4 Participants n=8 Participants	10 Participants n=22 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Week 32

Population: Participants with available data at week 32

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=5 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=1 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants With an Ankylosing Spondylitis Disease Activity Score (ASDAS) of Inactive Disease at Week 32	80.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and at each time point

The EQ-5D-3L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-3L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 3 levels of severity (1: indicating no problem, 2: indicating some/moderate problems, 3: indicating extreme problems). A single preference-weighted health utility index score was calculated by applying country-specific weights, with scores ranging from approximately 0 (death) to 1 (full health).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Week 32	0.446 units on a scale Standard Deviation 0.181	-0.287 units on a scale Standard Deviation NA Cannot be calculated when N=1
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Week 52	0.255 units on a scale Standard Deviation NA Cannot be calculated when N=1	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants who were employed and with available data at baseline and each time point.

The Work Productivity and Activity Impairment (WPAI) axSpA is an axSpA specific questionnaire consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=11 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=5 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Presenteeism Week 32	-23.3 percent impairment Standard Deviation 55.1	20.0 percent impairment Standard Deviation NA Could not be calculated when N=1

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants who were employed and with available data at baseline and each time point.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=11 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=6 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Absenteeism Week 32	-100.0 percent impairment Standard Deviation NA Could not be calculated when N=1	25.0 percent impairment Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Absenteeism Week 52	-100.0 percent impairment Standard Deviation NA Could not be calculated when N=1	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants who were employed and with available data at baseline and each time point.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=11 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=5 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Work Productivity Impairment Week 32	-90.0 percent impairment Standard Deviation NA Could not be calculated when N=1	27.5 percent impairment Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Work Productivity Impairment Week 52	-80.0 percent impairment Standard Deviation NA Could not be calculated when N=1	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=6 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Activity Impairment Week 32	-36.0 percent impairment Standard Deviation 15.2	30.0 percent impairment Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Activity Impairment Week 52	-30.0 percent impairment Standard Deviation NA Could not be calculated when N=1	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. The ASAS HI consists of 17 questions, each answered by the participant as agree (1) or disagree (0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, with a lower score indicating a better and a higher score indicating an inferior health status.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=13 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI) Week 32	-4.00 score on a scale Standard Deviation 2.45	3.00 score on a scale Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI) Week 52	-3.00 score on a scale Standard Deviation NA Could not be calculated when N=1	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale \[NRS\]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index Week 32	-3.96 score on a scale Standard Deviation 1.68	3.20 score on a scale Standard Deviation NA Could not be calculated when N=1
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index Week 52	-1.83 score on a scale Standard Deviation 3.18	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale \[NRS\]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. A BASDAI 50 response is defined as improvement of 50% or more from baseline in BASDAI score.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants Achieving a BASDAI 50 Response Week 32	60.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving a BASDAI 50 Response Week 52	33.3 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

The Bath Ankylosing Spondylitis Functional Index (BASFI) is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities, on a numeric rating scale (NRS) ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 (best) to 10 (worst).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Week 32	-2.46 score on a scale Standard Deviation 2.14	-1.50 score on a scale Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Week 52	-1.40 score on a scale Standard Deviation 0.849	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." Change from baseline in ASDAS calculated using CRP is reported.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in ASDAS(CRP) Week 32	-1.29 score on a scale Standard Deviation 0.833	—
Change From Baseline in ASDAS(CRP) Week 52	-0.654 score on a scale Standard Deviation 1.22	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

ASDAS Major Improvement is defined as a change from baseline ≤ -2.0. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." The percentage of participants with major improvement in ASDAS calculated using CRP is reported.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants Achieving ASDAS(CRP) Major Improvement Week 32	20.0 percentage of participants	—
Percentage of Participants Achieving ASDAS(CRP) Major Improvement Week 52	33.3 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

ASDAS clinically important improvement is defined as a change from baseline ≤ -1.1. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." The percentage of participants with clinically important improvement in ASDAS calculated using CRP is reported.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants Achieving ASDAS(CRP) Clinically Important Improvement Week 32	60.0 percentage of participants	—
Percentage of Participants Achieving ASDAS(CRP) Clinically Important Improvement Week 52	33.3 percentage of participants	—

SECONDARY outcome

Timeframe: Week 52

Population: Participants with available data at week 52

ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." The percentage of participants with ASDAS inactive disease (defined as ASDAS \< 1.3) calculated using CRP is reported.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=3 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants With ASDAS Inactive Disease at Week 52	33.3 percentage of participants	—

SECONDARY outcome

Timeframe: Week 32 and week 52

Population: Participants with available data at each time point

ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." The percentage of participants with ASDAS low disease activity (defined as ASDAS \< 2.1) calculated using CRP is reported.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants With ASDAS Low Disease Activity Week 32	80.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With ASDAS Low Disease Activity Week 52	66.7 percentage of participants	—

SECONDARY outcome

Timeframe: Week 32 and week 52

Population: Participants with available data at each time point

ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." The percentage of participants with ASDAS moderate disease activity (defined as an ASDAS ≥ 1.3 to \< 2.1) calculated using CRP is reported.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants With ASDAS Moderate Disease Activity Week 32	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With ASDAS Moderate Disease Activity Week 52	33.3 percentage of participants	—

SECONDARY outcome

Timeframe: Week 32 and week 52

Population: Participants with available data at each time point

ASDAS high disease activity is defined as an ASDAS ≥ 2.1 to \< 3.5. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." The percentage of participants with high disease activity (defined as an ASDAS ≥ 2.1 to \< 3.5) calculated using CRP is reported.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants With ASDAS High Disease Activity Week 32	20.0 percentage of participants	100.0 percentage of participants
Percentage of Participants With ASDAS High Disease Activity Week 52	33.3 percentage of participants	—

SECONDARY outcome

Timeframe: Week 32 and week 52

Population: Participants with available data at each time point

ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." The percentage of participants with very high disease activity (defined as an ASDAS \> 3.5) calculated using CRP is reported

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants With ASDAS Very High Disease Activity Week 32	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With ASDAS Very High Disease Activity Week 52	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain: * Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response Week 32	40.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response Week 52	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain: * Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants Achieving an ASAS 40 Response Week 32	20.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving an ASAS 40 Response Week 52	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 32 and week 52

Population: Participants with available data at each time point

ASAS partial remission is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains: * Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=7 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Percentage of Participants Achieving ASAS Partial Remission Week 32	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving ASAS Partial Remission Week 52	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and week 52

Population: The study terminated early due to slow enrollment and no data were collected.

Active inflammation of the sacroiliac (SI) joints as well as the cervical, thoracic and lumbar regions of the spine was assessed using magnetic resonance imaging (MRI). Images were scored by a central reader according to the Berlin MRI Score on a grading scale from 0 to 3, where Grade 0 indicates no active inflammation and Grade 3 indicates \> 66% inflammation of the sacroiliac joints or \> 50% active inflammation in the spine.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

The Physician's Global Assessment of Disease Activity was assessed using an NRS from 0 (no disease activity) to 10 (severe disease activity).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Physician's Global Assessment of Disease Activity Week 32	-4.00 score on a scale Standard Deviation 1.41	1.00 score on a scale Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Physician's Global Assessment of Disease Activity Week 52	-2.00 score on a scale Standard Deviation 3.00	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

The Patient's Global Assessment of Disease Activity was assessed using an NRS from 0 (no disease activity) to 10 (very severe disease activity).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Patient's Global Assessment of Disease Activity Week 32	-2.20 score on a scale Standard Deviation 3.90	4.00 score on a scale Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Patient's Global Assessment of Disease Activity Week 52	-1.00 score on a scale Standard Deviation 3.61	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

The Patient's Global Assessment of Pain was assessed on a NRS from 0 (no pain) to 10 (pain as bad as it could be).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Patient's Global Assessment of Pain Week 32	-1.60 score on a scale Standard Deviation 4.28	3.00 score on a scale Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Patient's Global Assessment of Pain Week 52	-0.333 score on a scale Standard Deviation 2.08	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

An assessment of 66 joints was performed by physical examination of each joint. The swollen joint count is the number of joints assessed as swollen (0 to 66).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Swollen Joint Count Week 32	0.0000 swollen joints Standard Deviation 0.0000	0.0000 swollen joints Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Swollen Joint Count Week 52	0.333 swollen joints Standard Deviation 0.577	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

An assessment of 68 joints was performed by physical examination of each joint. The tender joint count is the number of joints assessed as tender (0 to 68).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Tender Joint Count Week 32	-3.40 tender joints Standard Deviation 5.98	1.00 tender joints Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Tender Joint Count Week 52	-6.33 tender joints Standard Deviation 6.66	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at 13 entheses (sites where tendons or ligaments insert into the bone). All sites were scored as 0 (absent) or 1 (present). The MASES is the sum of all site scores (from 0 to 13).

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) Week 32	-0.800 score on a scale Standard Deviation 1.79	0.0000 score on a scale Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) Week 52	0.333 score on a scale Standard Deviation 1.53	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as 0 for no dactylitis or 1 for dactylitis present. The dactylitis count, ranging from 0 to 20, is the total number of digits on the hands and feet with dactylitis present.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Dactylitis Count Week 32	0.0000 digits with dactylitis Standard Deviation 0.0000	0.0000 digits with dactylitis Standard Deviation NA Could not be calculated when N=0
Change From Baseline in Dactylitis Count Week 52	0.0000 digits with dactylitis Standard Deviation 0.0000	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

Erythrocyte sedimentation rate measures the rate of fall (sedimentation) of erythrocytes (red blood cells) in a sample of blood that has been placed into a tall, thin, vertical tube as an indirect measure of the degree of inflammation present in the body.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) Week 32	-2.60 mm/hour Standard Deviation 3.05	0.0000 mm/hour Standard Deviation NA Could not be calculated when N=1
Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) Week 52	-4.00 mm/hour Standard Deviation 3.46	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

CRP is an acute phase reactant is a blood test marker for inflammation in the body. CRP levels rise in response to inflammation.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in C-reactive Protein (CRP) Week 32	-4.47 mg/L Standard Deviation 4.38	-1.00 mg/L Standard Deviation NA Could not be calculated when N=1
Change From Baseline in C-reactive Protein (CRP) Week 52	-3.47 mg/L Standard Deviation 6.00	—

SECONDARY outcome

Timeframe: Baseline, week 32, and week 52

Population: Participants with available data at baseline and each time point

The linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin) is a composite score based on 5 direct measurements of spinal mobility: lateral lumbar flexion, tragus-to-wall distance, lumbar flexion, intermalleolar distance, and cervical rotation angle. The total score ranges from 0 to 10, where higher scores indicate more limited mobility.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin) Week 32	-1.00 score on a scale Standard Deviation 0.632	-1.10 score on a scale Standard Deviation NA Could not be calculated when N=1
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin) Week 52	-1.20 score on a scale Standard Deviation 0.944	—

SECONDARY outcome

Timeframe: Up to Week 52

Anterior uveitis is an inflammation of the middle layer of the eye. which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.

Outcome measures

Outcome measures
Measure	Treat-to-Target (T2T) n=14 Participants Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.	Standard of Care (SOC) n=8 Participants Participants received treatment as prescribed by their physician according to the local standard of care.
Number of Participants With New Onset Anterior Uveitis	0 Participants	0 Participants

Adverse Events

Standard of Care (SOC)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Treat-to-Target (T2T)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care (SOC) n=8 participants at risk Participants received treatment as prescribed by their physician according to the local standard of care.	Treat-to-Target (T2T) n=14 participants at risk Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.
Hepatobiliary disorders CHOLECYSTITIS CHRONIC	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Up to 52 weeks

Other adverse events

Other adverse events
Measure	Standard of Care (SOC) n=8 participants at risk Participants received treatment as prescribed by their physician according to the local standard of care.	Treat-to-Target (T2T) n=14 participants at risk Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Ear and labyrinth disorders VERTIGO	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Gastrointestinal disorders ABDOMINAL PAIN UPPER	12.5% 1/8 • Number of events 1 • Up to 52 weeks	21.4% 3/14 • Number of events 4 • Up to 52 weeks
Gastrointestinal disorders ANAL FISSURE	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Gastrointestinal disorders DYSPEPSIA	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 2 • Up to 52 weeks
Gastrointestinal disorders GASTRITIS	0.00% 0/8 • Up to 52 weeks	14.3% 2/14 • Number of events 2 • Up to 52 weeks
Gastrointestinal disorders NAUSEA	0.00% 0/8 • Up to 52 weeks	14.3% 2/14 • Number of events 2 • Up to 52 weeks
Gastrointestinal disorders TOOTHACHE	12.5% 1/8 • Number of events 1 • Up to 52 weeks	0.00% 0/14 • Up to 52 weeks
General disorders FATIGUE	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Infections and infestations BRONCHITIS	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 2 • Up to 52 weeks
Infections and infestations CYSTITIS	12.5% 1/8 • Number of events 1 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Infections and infestations GASTROENTERITIS	25.0% 2/8 • Number of events 2 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Infections and infestations NASOPHARYNGITIS	37.5% 3/8 • Number of events 3 • Up to 52 weeks	28.6% 4/14 • Number of events 4 • Up to 52 weeks
Infections and infestations PULPITIS DENTAL	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Infections and infestations RHINITIS	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Infections and infestations SINUSITIS	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 4 • Up to 52 weeks
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	12.5% 1/8 • Number of events 1 • Up to 52 weeks	0.00% 0/14 • Up to 52 weeks
Infections and infestations URINARY TRACT INFECTION	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Infections and infestations WOUND INFECTION	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Injury, poisoning and procedural complications LACERATION	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Injury, poisoning and procedural complications POST-TRAUMATIC NECK SYNDROME	12.5% 1/8 • Number of events 1 • Up to 52 weeks	0.00% 0/14 • Up to 52 weeks
Musculoskeletal and connective tissue disorders ARTHRALGIA	12.5% 1/8 • Number of events 1 • Up to 52 weeks	0.00% 0/14 • Up to 52 weeks
Musculoskeletal and connective tissue disorders AXIAL SPONDYLOARTHRITIS	37.5% 3/8 • Number of events 3 • Up to 52 weeks	14.3% 2/14 • Number of events 3 • Up to 52 weeks
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/8 • Up to 52 weeks	14.3% 2/14 • Number of events 3 • Up to 52 weeks
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Nervous system disorders DIZZINESS	12.5% 1/8 • Number of events 1 • Up to 52 weeks	0.00% 0/14 • Up to 52 weeks
Nervous system disorders DYSAESTHESIA	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Nervous system disorders HEADACHE	0.00% 0/8 • Up to 52 weeks	14.3% 2/14 • Number of events 2 • Up to 52 weeks
Nervous system disorders MIGRAINE	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Psychiatric disorders DEPRESSION	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 2 • Up to 52 weeks
Psychiatric disorders MOOD ALTERED	12.5% 1/8 • Number of events 1 • Up to 52 weeks	0.00% 0/14 • Up to 52 weeks
Psychiatric disorders SLEEP DISORDER	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Reproductive system and breast disorders MENSTRUATION IRREGULAR	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Reproductive system and breast disorders OVARIAN CYST	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Reproductive system and breast disorders VULVOVAGINAL INFLAMMATION	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Respiratory, thoracic and mediastinal disorders COUGH	12.5% 1/8 • Number of events 1 • Up to 52 weeks	0.00% 0/14 • Up to 52 weeks
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Skin and subcutaneous tissue disorders PSORIASIS	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Skin and subcutaneous tissue disorders RASH	12.5% 1/8 • Number of events 1 • Up to 52 weeks	0.00% 0/14 • Up to 52 weeks
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks
Vascular disorders HYPERTENSION	0.00% 0/8 • Up to 52 weeks	7.1% 1/14 • Number of events 1 • Up to 52 weeks

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER