Trial Outcomes & Findings for Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease (NCT NCT02148718)
NCT ID: NCT02148718
Last Updated: 2018-03-01
Results Overview
Clinical response defined as a decrease of at least 3 points in Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Day 4
Results posted on
2018-03-01
Participant Flow
A total of 100 participants were enrolled in the study; 14 participants did not receive study drug and are excluded from the analyses.
Participant milestones
| Measure |
Adalimumab
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Overall Study
STARTED
|
86
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Adalimumab
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Overall Study
Protocol Violation
|
26
|
|
Overall Study
Discontinued Study Prematurely
|
5
|
Baseline Characteristics
Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
Baseline characteristics by cohort
| Measure |
Adalimumab
n=86 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Age, Continuous
|
37.73 years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
86 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 4Population: Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug
Clinical response defined as a decrease of at least 3 points in Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.
Outcome measures
| Measure |
Adalimumab
n=86 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Percentage of Participants With Clinical Response at Day 4
|
61.63 percentage of participants
Interval 50.51 to 71.92
|
SECONDARY outcome
Timeframe: Week 1Population: ITT population
Clinical response defined as a decrease of at least 3 points in HBI score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.
Outcome measures
| Measure |
Adalimumab
n=86 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Percentage of Participants With Clinical Response at Week 1
|
75.58 percentage of participants
Interval 65.13 to 84.2
|
SECONDARY outcome
Timeframe: Weeks 2 and 4Population: ITT population
Clinical remission defined as HBI \< 5. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.
Outcome measures
| Measure |
Adalimumab
n=86 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Percentage of Participants With Clinical Remission at Weeks 2 and 4
Week 2
|
54.65 percentage of participants
Interval 43.55 to 65.42
|
|
Percentage of Participants With Clinical Remission at Weeks 2 and 4
Week 4
|
62.79 percentage of participants
Interval 51.7 to 72.98
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
The EQ-5D-3L is a standardized instrument for use as a measure of health-related quality of life (HRQoL) and consists of 2 components: 1. The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. 2. The EQ-5D visual analog scale (VAS) is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L Index Score are presented.
Outcome measures
| Measure |
Adalimumab
n=82 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12
Baseline
|
0.62 units on a scale
Standard Deviation 0.22
|
|
European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12
Change from Baseline to Week 12
|
0.14 units on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
The EQ-5D-3L is a standardized instrument for use as a measure of HRQoL and consists of 2 components: 1. The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. 2. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented.
Outcome measures
| Measure |
Adalimumab
n=82 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12
Baseline
|
55.36 units on a scale
Standard Deviation 18.52
|
|
European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12
Change from Baseline to Week 12
|
15.37 units on a scale
Standard Deviation 21.36
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
The IBDQ-36 is used to assess the HRQoL related to bowel symptoms. The IBDQ-36 overall score is calculated as the sum of thirty-six items, each scored on a 1 to 7 likert point scale, and ranges from 7 to 252. The highest score indicates the best HRQoL related to bowel symptoms. A positive change in IBDQ-36 overall score indicates an improvement in HRQoL due to inflammatory bowel disease. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented.
Outcome measures
| Measure |
Adalimumab
n=78 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
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|---|---|
|
Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12
Baseline
|
145.1 units on a scale
Standard Deviation 35.83
|
|
Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12
Change from Baseline to Week 12
|
44.72 units on a scale
Standard Deviation 37.98
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
The D-FIS is used to measure the impact of fatigue on the daily lives of persons. The D-FIS overall score was calculated as the sum of eight items, each scored on a 0 to 4 point scale, and ranges from 0 to 32. A higher score indicates a higher impact of fatigue on daily life. A negative change in D-FIS Overall Score means an improvement in HRQoL due to fatigue. Mean Baseline and mean change from Baseline to Week 12 are presented.
Outcome measures
| Measure |
Adalimumab
n=79 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12
Baseline
|
14.45 units on a scale
Standard Deviation 8.53
|
|
Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12
Change from Baseline to Week 12
|
-4.69 units on a scale
Standard Deviation 8.44
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and coagulation (activated partial thromboplastin time \[aPTT\], international normalized ratio \[INR\], and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 are presented.
Outcome measures
| Measure |
Adalimumab
n=84 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin
Baseline
|
13.01 g/dL
Standard Deviation 1.40
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin
Change from Baseline to Week 12
|
0.27 g/dL
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Outcome measures
| Measure |
Adalimumab
n=84 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit
Baseline
|
39.47 % volume
Standard Deviation 3.99
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit
Change from Baseline to Week 12
|
0.86 % volume
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Outcome measures
| Measure |
Adalimumab
n=84 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Leukocytes Change from Baseline to Week 12
|
-1.62 cellsx10^3/uL
Standard Deviation 2.87
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Neutrophils Baseline
|
5.61 cellsx10^3/uL
Standard Deviation 2.86
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Leukocytes Baseline
|
8.11 cellsx10^3/uL
Standard Deviation 3.23
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Neutrophils Change from Baseline to Week 12
|
-1.99 cellsx10^3/uL
Standard Deviation 2.87
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Lymphocytes Baseline
|
1.80 cellsx10^3/uL
Standard Deviation 0.94
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Lymphocytes Change from Baseline to Week 12
|
0.39 cellsx10^3/uL
Standard Deviation 0.76
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Monocytes Baseline
|
0.50 cellsx10^3/uL
Standard Deviation 0.25
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Monocytes Change from Baseline to Week 12
|
-0.009 cellsx10^3/uL
Standard Deviation 0.219
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Eosinophils Baseline
|
0.17 cellsx10^3/uL
Standard Deviation 0.15
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Eosinophils Change from Baseline to Week 12
|
-0.010 cellsx10^3/uL
Standard Deviation 0.095
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Basophils Baseline
|
0.02 cellsx10^3/uL
Standard Deviation 0.02
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Basophils Change from Baseline to Week 12
|
0.003 cellsx10^3/uL
Standard Deviation 0.033
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Platelets Baseline
|
316.1 cellsx10^3/uL
Standard Deviation 90.1
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
Platelets Change from Baseline to Week 12
|
-40.4 cellsx10^3/uL
Standard Deviation 76.4
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Outcome measures
| Measure |
Adalimumab
n=84 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes
Baseline
|
4.37 cellsx10^6/uL
Standard Deviation 0.51
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes
Change from Baseline to Week 12
|
0.052 cellsx10^6/uL
Standard Deviation 0.308
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Outcome measures
| Measure |
Adalimumab
n=84 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR)
Baseline
|
19.49 mm/1h
Standard Deviation 18.38
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR)
Change from Baseline to Week 12
|
-7.48 mm/1h
Standard Deviation 14.26
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Outcome measures
| Measure |
Adalimumab
n=85 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)
Baseline
|
11.06 U/L
Standard Deviation 16.2
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)
Change from Baseline to Week 12
|
-7.61 U/L
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Outcome measures
| Measure |
Adalimumab
n=74 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin
Baseline
|
1,550.4 mg/kg
Standard Deviation 2,798.4
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin
Change from Baseline to Week 12
|
-1,043.8 mg/kg
Standard Deviation 2,895.3
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Outcome measures
| Measure |
Adalimumab
n=85 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)
Baseline
|
30.58 sec
Standard Deviation 3.89
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)
Change from Baseline to Week 12
|
0.76 sec
Standard Deviation 3.97
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Outcome measures
| Measure |
Adalimumab
n=85 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR)
Baseline
|
1.05 ratio
Standard Deviation 0.06
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR)
Change from Baseline to Week 12
|
0.02 ratio
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 12Population: All participants in the ITT population with evaluable data
Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.
Outcome measures
| Measure |
Adalimumab
n=85 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen
Baseline
|
374.5 mg/dL
Standard Deviation 68.17
|
|
Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen
Change from Baseline to Week 12
|
-43.6 mg/dL
Standard Deviation 65.7
|
SECONDARY outcome
Timeframe: Up to Week 12Population: ITT population
The percentage of participants with clinical response (defined as decrease of at least 3 points in HBI score) at Day 4 or Week 1 and clinical remission (defined as a HBI \< 5) at Week 12.
Outcome measures
| Measure |
Adalimumab
n=86 Participants
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12
|
58.90 percentage of participants
|
Adverse Events
Adalimumab
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab
n=86 participants at risk
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Pyrexia
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Pneumonia
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
Other adverse events
| Measure |
Adalimumab
n=86 participants at risk
Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Ear and labyrinth disorders
Ear pain
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Eye disorders
Eyelid disorder
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Eye disorders
Lacrimation increased
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Eye disorders
Presbyopia
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Abdominal mass
|
5.8%
5/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.5%
3/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.3%
2/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Crohn's disease
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
3/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Subileus
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
6/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Asthenia
|
2.3%
2/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Fatigue
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
General physical health deterioration
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
Pyrexia
|
2.3%
2/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Immune system disorders
Drug hypersensitivity
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Cellulitis
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Conjunctivitis
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Folliculitis
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Herpes virus infection
|
3.5%
3/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Influenza
|
4.7%
4/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Pharyngitis
|
3.5%
3/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Pharyngotonsillitis
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Rash pustular
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Respiratory tract infection
|
2.3%
2/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Rotavirus infection
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Tooth infection
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
3/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Blood triglycerides increased
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Transaminases increased
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Weight decreased
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
4/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Headache
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Migraine
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
Anxiety
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
2/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
4.7%
4/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
2/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
Hypertension
|
1.2%
1/86 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
Additional Information
Global Medical Services
AbbVie
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER