Trial Outcomes & Findings for A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy (NCT NCT01960855)
NCT ID: NCT01960855
Last Updated: 2021-08-24
Results Overview
Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hs CRP). Last observation carried forward (LOCF) was used for missing data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
276 participants
Primary outcome timeframe
Baseline (Week 0) and Week 12
Results posted on
2021-08-24
Participant Flow
The study included a screening period of 30 days.
Participant milestones
| Measure |
Placebo BID
Placebo twice daily (BID) for 12 weeks.
|
ABT-494 3 mg BID
ABT-494 3 mg twice daily (BID) for 12 weeks.
|
ABT-494 6 mg BID
ABT-494 6 mg twice daily (BID) for 12 weeks.
|
ABT-494 12 mg BID
ABT-494 12 mg twice daily (BID) for 12 weeks.
|
ABT-494 18 mg BID
ABT-494 18 mg twice daily (BID) for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
55
|
55
|
55
|
55
|
|
Overall Study
COMPLETED
|
45
|
51
|
46
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
9
|
4
|
5
|
Reasons for withdrawal
| Measure |
Placebo BID
Placebo twice daily (BID) for 12 weeks.
|
ABT-494 3 mg BID
ABT-494 3 mg twice daily (BID) for 12 weeks.
|
ABT-494 6 mg BID
ABT-494 6 mg twice daily (BID) for 12 weeks.
|
ABT-494 12 mg BID
ABT-494 12 mg twice daily (BID) for 12 weeks.
|
ABT-494 18 mg BID
ABT-494 18 mg twice daily (BID) for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Subject noncompliant
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
6
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
2
|
1
|
1
|
1
|
0
|
|
Overall Study
Consent withdrawn by subject
|
3
|
1
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
0
|
2
|
Baseline Characteristics
A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy
Baseline characteristics by cohort
| Measure |
Placebo BID
n=56 Participants
Placebo twice daily (BID) for 12 weeks.
|
ABT-494 3 mg BID
n=55 Participants
ABT-494 3 mg twice daily (BID) for 12 weeks.
|
ABT-494 6 mg BID
n=55 Participants
ABT-494 6 mg twice daily (BID) for 12 weeks.
|
ABT-494 12 mg BID
n=55 Participants
ABT-494 12 mg twice daily (BID) for 12 weeks.
|
ABT-494 18 mg BID
n=55 Participants
ABT-494 18 mg twice daily (BID) for 12 weeks.
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 12.04 • n=93 Participants
|
57 years
STANDARD_DEVIATION 13.06 • n=4 Participants
|
56.3 years
STANDARD_DEVIATION 11.71 • n=27 Participants
|
59.1 years
STANDARD_DEVIATION 11.4 • n=483 Participants
|
56.7 years
STANDARD_DEVIATION 12.39 • n=36 Participants
|
57.3 years
STANDARD_DEVIATION 12.12 • n=10 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
42 Participants
n=36 Participants
|
221 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
55 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: Subjects in the modified intent-to-treat (mITT) population with a baseline value and at least 1 post-baseline value
Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hs CRP). Last observation carried forward (LOCF) was used for missing data.
Outcome measures
| Measure |
Placebo BID
n=54 Participants
Placebo twice daily (BID) for 12 weeks.
|
ABT-494 3 mg BID
n=54 Participants
ABT-494 3 mg twice daily (BID) for 12 weeks.
|
ABT-494 6 mg BID
n=52 Participants
ABT-494 6 mg twice daily (BID) for 12 weeks.
|
ABT-494 12 mg BID
n=55 Participants
ABT-494 12 mg twice daily (BID) for 12 weeks.
|
ABT-494 18 mg BID
n=55 Participants
ABT-494 18 mg twice daily (BID) for 12 weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
|
19 Participants
|
30 Participants
|
33 Participants
|
40 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: Subjects in the mITT population with a baseline value and at least 1 post-baseline value.
Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.
Outcome measures
| Measure |
Placebo BID
n=53 Participants
Placebo twice daily (BID) for 12 weeks.
|
ABT-494 3 mg BID
n=54 Participants
ABT-494 3 mg twice daily (BID) for 12 weeks.
|
ABT-494 6 mg BID
n=52 Participants
ABT-494 6 mg twice daily (BID) for 12 weeks.
|
ABT-494 12 mg BID
n=55 Participants
ABT-494 12 mg twice daily (BID) for 12 weeks.
|
ABT-494 18 mg BID
n=55 Participants
ABT-494 18 mg twice daily (BID) for 12 weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
|
9 Participants
|
13 Participants
|
20 Participants
|
24 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: Subjects in the mITT population with a baseline value and at least 1 post-baseline value.
Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.
Outcome measures
| Measure |
Placebo BID
n=55 Participants
Placebo twice daily (BID) for 12 weeks.
|
ABT-494 3 mg BID
n=54 Participants
ABT-494 3 mg twice daily (BID) for 12 weeks.
|
ABT-494 6 mg BID
n=52 Participants
ABT-494 6 mg twice daily (BID) for 12 weeks.
|
ABT-494 12 mg BID
n=55 Participants
ABT-494 12 mg twice daily (BID) for 12 weeks.
|
ABT-494 18 mg BID
n=55 Participants
ABT-494 18 mg twice daily (BID) for 12 weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
|
2 Participants
|
7 Participants
|
14 Participants
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: Subjects in the mITT population with a baseline value and at least 1 post-baseline value.
LDA is defined as DAS28 from 2.6 to \< 3.2 at Week 12. CR is defined as DAS28 (CRP) \< 2.6 at Week 12. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission. LOCF was used.
Outcome measures
| Measure |
Placebo BID
n=55 Participants
Placebo twice daily (BID) for 12 weeks.
|
ABT-494 3 mg BID
n=54 Participants
ABT-494 3 mg twice daily (BID) for 12 weeks.
|
ABT-494 6 mg BID
n=53 Participants
ABT-494 6 mg twice daily (BID) for 12 weeks.
|
ABT-494 12 mg BID
n=55 Participants
ABT-494 12 mg twice daily (BID) for 12 weeks.
|
ABT-494 18 mg BID
n=55 Participants
ABT-494 18 mg twice daily (BID) for 12 weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects Achieving Low Disease Activity (LDA) Based on Disease Activity Score (DAS28) or Clinical Remission (CR) Based on (DAS28) at Week 12
|
14 Participants
|
18 Participants
|
20 Participants
|
29 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: Subjects in the mITT population with a baseline value and at least 1 post-baseline value.
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission. LOCF was used.
Outcome measures
| Measure |
Placebo BID
n=55 Participants
Placebo twice daily (BID) for 12 weeks.
|
ABT-494 3 mg BID
n=54 Participants
ABT-494 3 mg twice daily (BID) for 12 weeks.
|
ABT-494 6 mg BID
n=53 Participants
ABT-494 6 mg twice daily (BID) for 12 weeks.
|
ABT-494 12 mg BID
n=55 Participants
ABT-494 12 mg twice daily (BID) for 12 weeks.
|
ABT-494 18 mg BID
n=55 Participants
ABT-494 18 mg twice daily (BID) for 12 weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects Achieving CR Based on DAS28 at Week 12
|
7 Participants
|
13 Participants
|
14 Participants
|
18 Participants
|
17 Participants
|
Adverse Events
Placebo BID
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
ABT-494 3 mg BID
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
ABT-494 6 mg BID
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
ABT-494 12 mg BID
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
ABT-494 18 mg BID
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo BID
n=56 participants at risk
Placebo twice daily (BID) for 12 weeks.
|
ABT-494 3 mg BID
n=55 participants at risk
ABT-494 3 mg twice daily (BID) for 12 weeks.
|
ABT-494 6 mg BID
n=55 participants at risk
ABT-494 6 mg twice daily (BID) for 12 weeks.
|
ABT-494 12 mg BID
n=55 participants at risk
ABT-494 12 mg twice daily (BID) for 12 weeks.
|
ABT-494 18 mg BID
n=55 participants at risk
ABT-494 18 mg twice daily (BID) for 12 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIECTASIS
|
1.8%
1/56 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
Other adverse events
| Measure |
Placebo BID
n=56 participants at risk
Placebo twice daily (BID) for 12 weeks.
|
ABT-494 3 mg BID
n=55 participants at risk
ABT-494 3 mg twice daily (BID) for 12 weeks.
|
ABT-494 6 mg BID
n=55 participants at risk
ABT-494 6 mg twice daily (BID) for 12 weeks.
|
ABT-494 12 mg BID
n=55 participants at risk
ABT-494 12 mg twice daily (BID) for 12 weeks.
|
ABT-494 18 mg BID
n=55 participants at risk
ABT-494 18 mg twice daily (BID) for 12 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
7.3%
4/55 • Number of events 7 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Gastrointestinal disorders
NAUSEA
|
1.8%
1/56 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
7.3%
4/55 • Number of events 4 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
3.6%
2/55 • Number of events 3 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
7.3%
4/55 • Number of events 4 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
General disorders
PYREXIA
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
7.3%
4/55 • Number of events 5 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Infections and infestations
GASTROENTERITIS
|
1.8%
1/56 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
5.5%
3/55 • Number of events 4 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Infections and infestations
SINUSITIS
|
5.4%
3/56 • Number of events 3 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.8%
1/56 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
7.3%
4/55 • Number of events 5 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
7.3%
4/55 • Number of events 4 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.6%
2/56 • Number of events 2 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
12.7%
7/55 • Number of events 9 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
9.1%
5/55 • Number of events 5 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
1.8%
1/56 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/56 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Nervous system disorders
HEADACHE
|
1.8%
1/56 • Number of events 2 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
5.5%
3/55 • Number of events 4 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
5.5%
3/55 • Number of events 4 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
5.5%
3/55 • Number of events 6 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.8%
1/56 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
0.00%
0/55 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
|
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.
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Restriction type: OTHER