Trial Outcomes & Findings for A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis (NCT NCT02384538)
NCT ID: NCT02384538
Last Updated: 2017-08-11
Results Overview
The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
132 participants
Primary outcome timeframe
Week 0 (Baseline), Week 16
Results posted on
2017-08-11
Participant Flow
A total of 132 participants were randomized; 1 participant who was randomized to the ABT-981 treatment group did not receive a dose of study drug and was excluded from the analyses, for a total of 131 participants in the modified intent-to-treat population (mITT).
Participant milestones
| Measure |
Placebo
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
64
|
|
Overall Study
COMPLETED
|
61
|
49
|
|
Overall Study
NOT COMPLETED
|
6
|
15
|
Reasons for withdrawal
| Measure |
Placebo
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Lack of Efficacy
|
4
|
4
|
|
Overall Study
Withdrew Consent
|
0
|
4
|
|
Overall Study
Other
|
1
|
3
|
Baseline Characteristics
A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=67 Participants
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
n=64 Participants
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 7.325 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 8.132 • n=7 Participants
|
65.7 years
STANDARD_DEVIATION 7.700 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 (Baseline), Week 16Population: mITT population: all randomized participants who received at least 1 dose of study drug.
The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
n=64 Participants
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16
|
-10.74 units on a scale
Interval -15.433 to -6.045
|
-9.22 units on a scale
Interval -13.798 to -4.645
|
SECONDARY outcome
Timeframe: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26Population: All participants in the mITT population.
The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
n=64 Participants
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit
Week 2
|
-3.25 units on a scale
Interval -7.058 to 0.55
|
-3.27 units on a scale
Interval -6.983 to 0.438
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit
Week 8
|
-8.90 units on a scale
Interval -13.065 to -4.744
|
-6.44 units on a scale
Interval -10.488 to -2.384
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit
Week 16
|
-10.74 units on a scale
Interval -15.443 to -6.045
|
-9.22 units on a scale
Interval -13.798 to -4.645
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit
Week 20
|
-7.28 units on a scale
Interval -11.969 to -2.591
|
-8.37 units on a scale
Interval -12.941 to -3.807
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit
Week 4
|
-5.01 units on a scale
Interval -9.144 to -0.885
|
-4.26 units on a scale
Interval -8.28 to -0.237
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit
Week 12
|
-8.31 units on a scale
Interval -12.593 to -4.03
|
-5.64 units on a scale
Interval -9.809 to -1.469
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit
Week 26
|
-8.76 units on a scale
Interval -13.782 to -3.737
|
-10.37 units on a scale
Interval -15.264 to -5.481
|
SECONDARY outcome
Timeframe: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26Population: All participants in the mITT population.
The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The physical function subdomain score ranges from 0 to 90; lower scores indicate better status. A decrease in the physical function subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
n=64 Participants
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit
Week 8
|
-14.25 units on a scale
Interval -21.729 to -6.763
|
-8.97 units on a scale
Interval -16.211 to -1.725
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit
Week 4
|
-8.43 units on a scale
Interval -15.879 to -0.974
|
-7.04 units on a scale
Interval -14.249 to 0.177
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit
Week 2
|
-6.23 units on a scale
Interval -13.098 to 0.63
|
-4.79 units on a scale
Interval -11.44 to 1.861
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit
Week 12
|
-12.54 units on a scale
Interval -20.14 to -4.947
|
-8.53 units on a scale
Interval -15.887 to -1.182
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit
Week 16
|
-17.18 units on a scale
Interval -24.938 to -9.431
|
-14.64 units on a scale
Interval -22.142 to -7.133
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit
Week 20
|
-11.50 units on a scale
Interval -19.415 to -3.584
|
-12.53 units on a scale
Interval -20.189 to -4.867
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit
Week 26
|
-14.25 units on a scale
Interval -22.523 to -5.978
|
-16.39 units on a scale
Interval -24.402 to -8.388
|
SECONDARY outcome
Timeframe: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26Population: All participants in the mITT population.
The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The stiffness subdomain score ranges from 0 to 10; lower scores indicate better status. A decrease in the stiffness subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
n=64 Participants
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit
Week 16
|
-1.76 units on a scale
Interval -2.885 to -0.633
|
-1.61 units on a scale
Interval -2.695 to -0.522
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit
Week 20
|
-1.34 units on a scale
Interval -2.515 to -0.169
|
-1.85 units on a scale
Interval -2.986 to -0.722
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit
Week 2
|
-0.74 units on a scale
Interval -1.692 to 0.215
|
-0.96 units on a scale
Interval -1.877 to -0.036
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit
Week 4
|
-0.98 units on a scale
Interval -1.937 to -0.028
|
-1.24 units on a scale
Interval -2.163 to -0.321
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit
Week 8
|
-1.51 units on a scale
Interval -2.535 to -0.493
|
-1.43 units on a scale
Interval -2.412 to -0.441
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit
Week 12
|
-1.65 units on a scale
Interval -2.706 to -0.599
|
-1.23 units on a scale
Interval -2.244 to -0.211
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit
Week 26
|
-1.94 units on a scale
Interval -3.017 to -0.859
|
-2.45 units on a scale
Interval -3.492 to -1.41
|
SECONDARY outcome
Timeframe: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26Population: All participants in the mITT population.
The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The total score ranges from 0 to 150; lower scores indicate better status. A decrease in the total score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
n=64 Participants
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit
Week 2
|
-10.01 units on a scale
Interval -21.037 to 1.019
|
-8.85 units on a scale
Interval -19.545 to 1.835
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit
Week 4
|
-14.06 units on a scale
Interval -26.185 to -1.93
|
-12.18 units on a scale
Interval -23.928 to -0.439
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit
Week 8
|
-24.52 units on a scale
Interval -36.66 to -12.373
|
-16.65 units on a scale
Interval -28.406 to -4.886
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit
Week 12
|
-22.29 units on a scale
Interval -34.714 to -9.873
|
-15.15 units on a scale
Interval -27.181 to -3.124
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit
Week 16
|
-29.37 units on a scale
Interval -42.469 to -16.264
|
-25.12 units on a scale
Interval -37.808 to -12.429
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit
Week 20
|
-19.68 units on a scale
Interval -32.894 to -6.458
|
-22.33 units on a scale
Interval -35.128 to -9.526
|
|
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit
Week 26
|
-24.73 units on a scale
Interval -38.636 to -10.82
|
-28.99 units on a scale
Interval -42.461 to -15.523
|
SECONDARY outcome
Timeframe: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26Population: All participants in the mITT population.
Participants rated the pain intensity of each hand during the previous 48 hours using an 11-point scale (NRS-11). The change from baseline to each visit in NRS-11 in the index hand (the hand with the most disease) are presented. Scores range from 0 to 10 points, with higher scores indicating greater pain intensity. A decrease in the NRS-11 score represents a decrease in pain intensity.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
n=64 Participants
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit
Week 2
|
-0.62 units on a scale
Interval -1.55 to 0.32
|
-0.69 units on a scale
Interval -1.613 to 0.228
|
|
Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit
Week 4
|
-1.18 units on a scale
Interval -2.163 to -0.195
|
-1.06 units on a scale
Interval -2.025 to -0.088
|
|
Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit
Week 8
|
-2.40 units on a scale
Interval -3.339 to -1.465
|
-1.74 units on a scale
Interval -2.66 to -0.814
|
|
Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit
Week 12
|
-1.65 units on a scale
Interval -2.434 to -0.875
|
-0.81 units on a scale
Interval -1.629 to 0.01
|
|
Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit
Week 16
|
-2.05 units on a scale
Interval -3.085 to -1.017
|
-1.60 units on a scale
Interval -2.626 to -0.578
|
|
Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit
Week 20
|
-1.61 units on a scale
Interval -2.749 to -0.477
|
-1.75 units on a scale
Interval -2.892 to -0.612
|
|
Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit
Week 26
|
-2.02 units on a scale
Interval -3.132 to -0.901
|
-2.52 units on a scale
Interval -3.62 to -1.415
|
SECONDARY outcome
Timeframe: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26Population: All participants in the mITT population.
Participants were asked how much they were affected by hand OA by responding to the question "Considering all the ways your hand OA affects you, how have you been during the last 48 hours?" using an 11-point scale (NRS-11). Scores range from 0 to 10 points, with higher scores indicating greater effect of hand OA on the participant. A decrease in the NRS-11 score represents an improvement the effect of hand OA on the participant.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
n=64 Participants
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit
Week 2
|
-0.52 units on a scale
Interval -1.399 to 0.351
|
-0.54 units on a scale
Interval -1.403 to 0.316
|
|
Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit
Week 4
|
-1.31 units on a scale
Interval -2.277 to -0.335
|
-1.13 units on a scale
Interval -2.083 to -0.176
|
|
Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit
Week 8
|
-1.85 units on a scale
Interval -2.74 to -0.952
|
-1.20 units on a scale
Interval -2.08 to -0.324
|
|
Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit
Week 12
|
-1.78 units on a scale
Interval -2.567 to -0.993
|
-1.17 units on a scale
Interval -1.997 to -0.348
|
|
Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit
Week 16
|
-2.20 units on a scale
Interval -3.225 to -1.185
|
-1.69 units on a scale
Interval -2.697 to -0.677
|
|
Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit
Week 20
|
-1.73 units on a scale
Interval -2.836 to -0.627
|
-1.77 units on a scale
Interval -2.879 to -0.666
|
|
Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit
Week 26
|
-2.00 units on a scale
Interval -3.133 to -0.874
|
-2.35 units on a scale
Interval -3.465 to -1.236
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
ABT-981
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=67 participants at risk
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
n=64 participants at risk
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
1.5%
1/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
0.00%
0/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.00%
0/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
1.6%
1/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
1.6%
1/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE BREAST CARCINOMA
|
1.5%
1/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
0.00%
0/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
1.6%
1/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=67 participants at risk
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
|
ABT-981
n=64 participants at risk
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
9.4%
6/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
9.0%
6/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
6.2%
4/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
3.0%
2/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
12.5%
8/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
General disorders
FATIGUE
|
0.00%
0/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
6.2%
4/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
10.9%
7/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
General disorders
INJECTION SITE RASH
|
4.5%
3/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
10.9%
7/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
General disorders
INJECTION SITE REACTION
|
4.5%
3/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
10.9%
7/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
General disorders
PAIN
|
6.0%
4/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
0.00%
0/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
25.4%
17/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
20.3%
13/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.0%
4/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
6.2%
4/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
FALL
|
4.5%
3/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
6.2%
4/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.0%
6/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
6.2%
4/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.4%
11/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
4.7%
3/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.0%
4/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
4.7%
3/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Nervous system disorders
DIZZINESS
|
6.0%
4/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
6.2%
4/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
25.4%
17/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
15.6%
10/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
7.5%
5/67 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
6.2%
4/64 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
|
Additional Information
Global Medical Services
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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.
- Publication restrictions are in place
Restriction type: OTHER