Trial Outcomes & Findings for A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX) (NCT NCT02349451)

Last Updated: 2017-08-04

Results Overview

Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein \[hsCRP\]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

240 participants

Primary outcome timeframe

Week 12

Results posted on

2017-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo EW Double-blind placebo administered every week (EW) for 12 weeks	Adalimumab 40 mg EOW Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks	ABT-122 120 mg EW Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW Double-blind ABT-122 240 mg administered EW for 12 weeks
Overall Study STARTED	24	72	71	73
Overall Study COMPLETED	24	71	69	72
Overall Study NOT COMPLETED	0	1	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo EW Double-blind placebo administered every week (EW) for 12 weeks	Adalimumab 40 mg EOW Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks	ABT-122 120 mg EW Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW Double-blind ABT-122 240 mg administered EW for 12 weeks
Overall Study Withdrawal by Subject	0	1	2	1

Baseline Characteristics

A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo EW n=24 Participants Double-blind placebo administered EW for 12 weeks	Adalimumab 40 mg EOW n=72 Participants Double-blind adalimumab 40 mg administered EOW for 12 weeks	ABT-122 120 mg EW n=71 Participants Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW n=73 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks	Total n=240 Participants Total of all reporting groups
Age, Continuous	47.7 years STANDARD_DEVIATION 13.67 • n=93 Participants	50.5 years STANDARD_DEVIATION 12.03 • n=4 Participants	51.0 years STANDARD_DEVIATION 12.39 • n=27 Participants	47.4 years STANDARD_DEVIATION 13.77 • n=483 Participants	49.4 years STANDARD_DEVIATION 12.87 • n=36 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	33 Participants n=4 Participants	37 Participants n=27 Participants	37 Participants n=483 Participants	119 Participants n=36 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	39 Participants n=4 Participants	34 Participants n=27 Participants	36 Participants n=483 Participants	121 Participants n=36 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Non-responder imputation (NRI): missing responses are imputed as non-responders.

Outcome measures

Outcome measures
Measure	Placebo EW n=24 Participants Double-blind placebo administered EW for 12 weeks	ABT-122 120 mg EW n=71 Participants Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW n=73 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks	ABT-122 240 mg EW Double-blind ABT-122 240 mg administered EW for 12 weeks
American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo	25.0 percentage of participants Interval 11.7 to 45.2	64.8 percentage of participants Interval 53.2 to 74.9	75.3 percentage of participants Interval 64.3 to 83.9	—

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.

Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

Outcome measures

Outcome measures
Measure	Placebo EW n=72 Participants Double-blind placebo administered EW for 12 weeks	ABT-122 120 mg EW n=71 Participants Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW n=73 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks	ABT-122 240 mg EW Double-blind ABT-122 240 mg administered EW for 12 weeks
ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab	68.1 percentage of participants Interval 56.6 to 77.7	64.8 percentage of participants Interval 53.2 to 74.9	75.3 percentage of participants Interval 64.3 to 83.9	—

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.

Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

Outcome measures

Outcome measures
Measure	Placebo EW n=24 Participants Double-blind placebo administered EW for 12 weeks	ABT-122 120 mg EW n=72 Participants Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW n=71 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks	ABT-122 240 mg EW n=73 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks
ACR50 Response Rate at Week 12	12.5 percentage of participants Interval 3.5 to 31.8	37.5 percentage of participants Interval 27.2 to 49.1	36.6 percentage of participants Interval 26.3 to 48.3	53.4 percentage of participants Interval 42.1 to 64.4

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.

Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

Outcome measures

Outcome measures
Measure	Placebo EW n=24 Participants Double-blind placebo administered EW for 12 weeks	ABT-122 120 mg EW n=72 Participants Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW n=71 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks	ABT-122 240 mg EW n=73 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks
ACR70 Response Rate at Week 12	4.2 percentage of participants Interval 0.0 to 21.9	15.3 percentage of participants Interval 8.6 to 25.5	22.5 percentage of participants Interval 14.3 to 33.6	31.5 percentage of participants Interval 22.0 to 42.9

SECONDARY outcome

Timeframe: At Week 12

Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Last observation carried forward (LOCF): missing responses are imputed by calculation based on the last non-missing post-baseline component values.

ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%.

Outcome measures

Outcome measures
Measure	Placebo EW n=24 Participants Double-blind placebo administered EW for 12 weeks	ABT-122 120 mg EW n=72 Participants Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW n=71 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks	ABT-122 240 mg EW n=73 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks
ACRn at Week 12	-20.3 percentage improvement Interval -59.6 to 19.1	38.2 percentage improvement Interval 29.2 to 47.2	34.7 percentage improvement Interval 25.5 to 44.0	48.6 percentage improvement Interval 41.1 to 56.1

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity.

Outcome measures

Outcome measures
Measure	Placebo EW n=24 Participants Double-blind placebo administered EW for 12 weeks	ABT-122 120 mg EW n=72 Participants Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW n=71 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks	ABT-122 240 mg EW n=73 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks
Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12	-0.89 units on a scale Interval -1.32 to -0.45	-1.83 units on a scale Interval -2.08 to -1.58	-1.96 units on a scale Interval -2.21 to -1.7	-2.28 units on a scale Interval -2.53 to -2.03

SECONDARY outcome

Timeframe: Baseline, Week 12

PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo EW n=24 Participants Double-blind placebo administered EW for 12 weeks	ABT-122 120 mg EW n=72 Participants Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW n=71 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks	ABT-122 240 mg EW n=73 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12	-1.46 units on a scale Interval -2.01 to -0.9	-2.53 units on a scale Interval -2.85 to -2.22	-2.62 units on a scale Interval -2.94 to -2.31	-2.86 units on a scale Interval -3.18 to -2.55

SECONDARY outcome

Timeframe: Baseline, Week 12

Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness).

Outcome measures

Outcome measures
Measure	Placebo EW n=24 Participants Double-blind placebo administered EW for 12 weeks	ABT-122 120 mg EW n=72 Participants Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW n=71 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks	ABT-122 240 mg EW n=73 Participants Double-blind ABT-122 240 mg administered EW for 12 weeks
Change From Baseline in Psoriasis Target Lesion Score at Week 12	-1.81 units on a scale Interval -2.65 to -0.96	-4.16 units on a scale Interval -4.65 to -3.67	-4.98 units on a scale Interval -5.47 to -4.49	-4.53 units on a scale Interval -5.02 to -4.05

Adverse Events

Placebo EW

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Adalimumab 40 mg EOW

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

ABT-122 120 mg EW

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

ABT-122 240 mg EW

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo EW n=24 participants at risk Double-blind placebo administered EW for 12 weeks	Adalimumab 40 mg EOW n=72 participants at risk Double-blind adalimumab 40 mg administered EOW for 12 weeks	ABT-122 120 mg EW n=71 participants at risk Double-blind ABT-122 120 mg administered EW for 12 weeks	ABT-122 240 mg EW n=73 participants at risk Double-blind ABT-122 240 mg administered EW for 12 weeks
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	4.2% 1/24 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/72 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/73 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications SKIN ABRASION	4.2% 1/24 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/72 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/73 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	4.2% 1/24 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/72 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/73 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations HEART RATE DECREASED	0.00% 0/24 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/72 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.4% 1/73 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders SYNCOPE	0.00% 0/24 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/72 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.	1.4% 1/73 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks). A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Additional Information

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