Trial Outcomes & Findings for Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA) (NCT NCT01064856)

NCT ID: NCT01064856

Last Updated: 2021-07-07

Results Overview

Percentage of participants achieving the following composite response at Week 12: \>= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; \>= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA - Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and \>= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 165 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2021-07-07

Participant Flow

Participant milestones

Measure	Double-blind (DB) Adalimumab Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.	Double-blind Adalimumab / Open-label Adalimumab Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.	Double-blind Placebo / Open-label Adalimumab Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
Double-blind (DB) Period STARTED	84	81	0	0
Double-blind (DB) Period COMPLETED	82	81	0	0
Double-blind (DB) Period NOT COMPLETED	2	0	0	0
Open-label (OL) Period STARTED	0	0	82	81
Open-label (OL) Period COMPLETED	0	0	56	61
Open-label (OL) Period NOT COMPLETED	0	0	26	20

Reasons for withdrawal

Measure	Double-blind (DB) Adalimumab Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.	Double-blind Adalimumab / Open-label Adalimumab Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.	Double-blind Placebo / Open-label Adalimumab Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
Double-blind (DB) Period Adverse Event	1	0	0	0
Double-blind (DB) Period Consent withdrawn by participant	1	0	0	0
Open-label (OL) Period Adverse Event	0	0	12	6
Open-label (OL) Period Consent withdrawn by participant	0	0	5	6
Open-label (OL) Period Lost to Follow-up	0	0	2	1
Open-label (OL) Period Other	0	0	7	7

Baseline Characteristics

Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

Baseline characteristics by cohort

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.	Total n=165 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 10.79 • n=5 Participants	38.5 years STANDARD_DEVIATION 12.77 • n=7 Participants	40.6 years STANDARD_DEVIATION 11.94 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	42 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	39 Participants n=7 Participants	75 Participants n=5 Participants
Tender Joint Count (78 Joints)	12.95 units on a scale STANDARD_DEVIATION 12.79 • n=5 Participants	13.62 units on a scale STANDARD_DEVIATION 16.10 • n=7 Participants	13.28 units on a scale STANDARD_DEVIATION 14.46 • n=5 Participants
Swollen Joint Count (76 Joints)	6.12 units on a scale STANDARD_DEVIATION 5.58 • n=5 Participants	7.31 units on a scale STANDARD_DEVIATION 7.99 • n=7 Participants	6.70 units on a scale STANDARD_DEVIATION 6.87 • n=5 Participants
Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)	3.13 units on a scale STANDARD_DEVIATION 3.60 • n=5 Participants	3.59 units on a scale STANDARD_DEVIATION 3.39 • n=7 Participants	3.36 units on a scale STANDARD_DEVIATION 3.50 • n=5 Participants
Leeds Enthesitis Index	1.49 units on a scale STANDARD_DEVIATION 1.66 • n=5 Participants	1.42 units on a scale STANDARD_DEVIATION 1.61 • n=7 Participants	1.45 units on a scale STANDARD_DEVIATION 1.63 • n=5 Participants
Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score	3.83 units on a scale STANDARD_DEVIATION 4.03 • n=5 Participants	4.05 units on a scale STANDARD_DEVIATION 3.78 • n=7 Participants	3.94 units on a scale STANDARD_DEVIATION 3.90 • n=5 Participants
Total Enthesitis Count	6.73 units on a scale STANDARD_DEVIATION 6.95 • n=5 Participants	7.33 units on a scale STANDARD_DEVIATION 6.69 • n=7 Participants	7.02 units on a scale STANDARD_DEVIATION 6.81 • n=5 Participants
Patient Global Assessment (PTGA) of Disease Activity	65.24 mm STANDARD_DEVIATION 15.22 • n=5 Participants	66.43 mm STANDARD_DEVIATION 15.86 • n=7 Participants	65.82 mm STANDARD_DEVIATION 15.50 • n=5 Participants
PTGA - Pain	64.30 units on a scale STANDARD_DEVIATION 14.03 • n=5 Participants	65.60 units on a scale STANDARD_DEVIATION 15.89 • n=7 Participants	64.94 units on a scale STANDARD_DEVIATION 14.94 • n=5 Participants
Physician Global Assessment (PGA) of Disease Activity	60.29 units on a scale STANDARD_DEVIATION 15.53 • n=5 Participants	57.02 units on a scale STANDARD_DEVIATION 14.98 • n=7 Participants	58.68 units on a scale STANDARD_DEVIATION 15.31 • n=5 Participants
Ankylosing Spondylitis Disease Activity Score (ASDAS)	2.92 units on a scale STANDARD_DEVIATION 0.84 • n=5 Participants	3.06 units on a scale STANDARD_DEVIATION 0.80 • n=7 Participants	2.99 units on a scale STANDARD_DEVIATION 0.82 • n=5 Participants
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	5.68 units on a scale STANDARD_DEVIATION 1.74 • n=5 Participants	5.57 units on a scale STANDARD_DEVIATION 1.58 • n=7 Participants	5.62 units on a scale STANDARD_DEVIATION 1.66 • n=5 Participants
Dactylitis Count	0.35 units on a scale STANDARD_DEVIATION 0.94 • n=5 Participants	0.65 units on a scale STANDARD_DEVIATION 1.25 • n=7 Participants	0.50 units on a scale STANDARD_DEVIATION 1.11 • n=5 Participants
Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS)	34.56 units on a scale STANDARD_DEVIATION 7.93 • n=5 Participants	34.48 units on a scale STANDARD_DEVIATION 7.62 • n=7 Participants	34.52 units on a scale STANDARD_DEVIATION 7.76 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug (ITT).

Percentage of participants achieving the following composite response at Week 12: >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA - Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and >= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12 Responder	39.3 percentage of participants	19.8 percentage of participants
Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12 Non-responder	60.7 percentage of participants	80.2 percentage of participants

PRIMARY outcome

Timeframe: Baseline (day of first study drug administration) through Week 156 plus 70 days

Population: Safety Analyses included all participants who received at least 1 dose of double-blind study drug.

An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Number of Participants With Adverse Events Any adverse event	47 participants	45 participants
Number of Participants With Adverse Events Any serious adverse event	1 participants	1 participants
Number of Participants With Adverse Events Any AE leading to discontinuation of study drug	3 participants	0 participants
Number of Participants With Adverse Events Any severe AE	4 participants	2 participants
Number of Participants With Adverse Events Any AE at least possibly drug related	21 participants	15 participants
Number of Participants With Adverse Events Any SAE at least possibly drug related	0 participants	0 participants
Number of Participants With Adverse Events Any infection	18 participants	24 participants

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.

A VAS was to be used for the Physician Global Assessment (PGA) of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. Last observation carried forward (LOCF): missing values were imputed using the last non-missing post-baseline value prior to the missing value.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12	-32.2 units on a scale Standard Deviation 22.52	-18.2 units on a scale Standard Deviation 22.93

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.

The BASDAI was to be completed at the designated study visits. The participant was to assess his/her disease activity using the BASDAI which consisted of a VAS scale used to answer 6 questions (Q1 through Q6) pertaining to symptoms experienced by the participant for the past week. Each question on the BASDAI was reported in centimeters (0 [none] to 10 [very severe] with one question's possible answers being in time increments [0 hours to ≥ 2 hours]). The overall BASDAI score ranges from 0 to 10 cm and was calculated as follows: BASDAI Score = 0.2 × (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). Lower scores indicate less disease activity. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12	-2.1 units on a scale Standard Deviation 2.32	-1 units on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.

The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12	-0.3 units on a scale Standard Deviation 0.44	-0.2 units on a scale Standard Deviation 0.47

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values.

The Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) is a 36-item generic health-related quality of life measure to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=83 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=79 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12	6.7 units on a scale Standard Deviation 7.85	2.4 units on a scale Standard Deviation 6.65

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.

Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12	-1.2 units on a scale Standard Deviation 2.67	-0.8 units on a scale Standard Deviation 2.38

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.

Assessment of enthesitis was performed in the following 6 domains: left and right lateral epicondyle, left and right medial femoral condyle, left and right Achilles tendon insertion. Tenderness at each site was quantified on a dichotomous basis: Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Leeds Enthesitis Index at Week 12	-0.8 units on a scale Standard Deviation 1.28	-0.1 units on a scale Standard Deviation 1.19

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.

Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was quantified on a dichotomous basis. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (worst possible score; 16 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12	-1.7 units on a scale Standard Deviation 2.43	-0.7 units on a scale Standard Deviation 2.21

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values for both Baseline and the post-baseline.

Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=83 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Dactylitis at Week 12	-0.2 units on a scale Standard Deviation 1.05	0.3 units on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.

Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 78 (worst possible score/78 joints with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=81 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Tender Joint Count (TJC) at Week 12	-5.9 units on a scale Standard Deviation 8.67	-1.8 units on a scale Standard Deviation 8.41

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.

Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 76 (worst possible score/76 joints with swelling). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=80 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Swollen Joint Count (SJC) at Week 12	-3.6 units on a scale Standard Deviation 4.27	-3.1 units on a scale Standard Deviation 5.64

SECONDARY outcome

Timeframe: Baseline (last measurement prior to first DB dose), Week 12

Population: Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and with non-missing values for both Baseline and post-baseline visit.

The ASDAS is a continuous disease activity score: low score indicates lower disease activity and higher values indicate higher disease activity. The score ranges from 0 to no defined upper limit. It is categorized into 4 disease activity states based on score: inactive disease (< 1.3), moderate (≥ 1.3 to < 2.1), high (≥ 2.1 to ≤ 3.5), and very high (> 3.5). Clinically important and major improvements in ASDAS are defined as a reduction from Baseline of ≥ 1.1 and ≥ 2.0 points, respectively. Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.

Outcome measures

Measure	Double-blind (DB) Adalimumab n=84 Participants Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Double-blind Placebo n=80 Participants Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12	-1.0 units on a scale Standard Deviation 1.07	-0.5 units on a scale Standard Deviation 0.90

Adverse Events

Double-blind Placebo

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Double-blind Adalimumab

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Any Adalimumab

Serious events: 24 serious events

Other events: 139 other events

Deaths: 0 deaths

Serious adverse events

Measure	Double-blind Placebo n=81 participants at risk Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.	Double-blind Adalimumab n=84 participants at risk Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Any Adalimumab n=165 participants at risk All randomized participants who had received at least 1 dose of adalimumab (blinded or open-label) at any time during the study (up to Week 156).
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Gastrointestinal disorders ABDOMINAL HERNIA	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Gastrointestinal disorders ANAL FISTULA	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Gastrointestinal disorders COLITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Gastrointestinal disorders CROHN'S DISEASE	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
General disorders CHEST PAIN	1.2% 1/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations CELLULITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations DIVERTICULITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations PYELONEPHRITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Injury, poisoning and procedural complications FIBULA FRACTURE	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Injury, poisoning and procedural complications SKULL FRACTURE	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Investigations MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Musculoskeletal and connective tissue disorders SACROILIITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Musculoskeletal and connective tissue disorders SPONDYLOARTHROPATHY	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.8% 3/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN OVARIAN TUMOUR	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PHAEOCHROMOCYTOMA	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Nervous system disorders BRAIN STEM HAEMORRHAGE	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Nervous system disorders CERVICOBRACHIAL SYNDROME	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Nervous system disorders VASCULITIS CEREBRAL	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Renal and urinary disorders CYSTITIS HAEMORRHAGIC	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Renal and urinary disorders RENAL DISORDER	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Respiratory, thoracic and mediastinal disorders PLEURISY	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.61% 1/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.

Other adverse events

Measure	Double-blind Placebo n=81 participants at risk Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.	Double-blind Adalimumab n=84 participants at risk Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.	Any Adalimumab n=165 participants at risk All randomized participants who had received at least 1 dose of adalimumab (blinded or open-label) at any time during the study (up to Week 156).
Blood and lymphatic system disorders LYMPHADENOPATHY	1.2% 1/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.8% 4/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	7.3% 12/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Gastrointestinal disorders DIARRHOEA	4.9% 4/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	9.1% 15/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Gastrointestinal disorders NAUSEA	3.7% 3/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	2.4% 2/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	6.1% 10/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
General disorders FATIGUE	1.2% 1/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	8.5% 14/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations BRONCHITIS	2.5% 2/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	13.9% 23/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations GASTROENTERITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	6.1% 10/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations NASOPHARYNGITIS	13.6% 11/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.8% 4/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	30.9% 51/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations PHARYNGITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	7.3% 12/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations RHINITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	7.9% 13/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations SINUSITIS	1.2% 1/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	9.1% 15/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	4.9% 4/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.8% 4/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	18.2% 30/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	6.7% 11/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	2.4% 2/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	5.5% 9/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Musculoskeletal and connective tissue disorders SPONDYLOARTHROPATHY	4.9% 4/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	7.1% 6/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	25.5% 42/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Nervous system disorders HEADACHE	3.7% 3/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.8% 4/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	10.3% 17/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Respiratory, thoracic and mediastinal disorders COUGH	2.5% 2/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	2.4% 2/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	7.3% 12/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	3.7% 3/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.6% 3/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	9.1% 15/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Vascular disorders HYPERTENSION	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	2.4% 2/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	7.3% 12/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.2% 7/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
General disorders INJECTION SITE REACTION	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.8% 8/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.6% 6/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Injury, poisoning and procedural complications FALL	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.8% 8/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.6% 6/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Investigations ALANINE AMINOTRANSFERASE INCREASED	2.5% 2/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.8% 8/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Investigations LIVER FUNCTION TEST ABNORMAL	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.6% 6/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	1.2% 1/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.0% 5/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Nervous system disorders PARAESTHESIA	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.6% 6/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Eye disorders DRY EYE	1.2% 1/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.0% 5/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Ear and labyrinth disorders VERTIGO	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.6% 6/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	1.2% 1/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.0% 5/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Skin and subcutaneous tissue disorders RASH	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.6% 6/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.2% 7/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.2% 7/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations CONJUNCTIVITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.6% 6/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations CYSTITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.2% 7/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.0% 5/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations INFLUENZA	1.2% 1/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.6% 3/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.8% 8/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations ORAL HERPES	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	3.0% 5/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations TONSILLITIS	0.00% 0/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	1.2% 1/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.8% 8/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.
Infections and infestations URINARY TRACT INFECTION	2.5% 2/81 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	0.00% 0/84 • Baseline (day of first study drug administration) through Week 156 plus 70 days.	4.2% 7/165 • Baseline (day of first study drug administration) through Week 156 plus 70 days.

Additional Information

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• 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.
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Restriction type: OTHER