Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease (NCT NCT02015793)

NCT ID: NCT02015793

Last Updated: 2018-05-30

Results Overview

Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Week 8

Results posted on

2018-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Low Induction Dose Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
Overall Study STARTED	15	15
Overall Study Completed Double-Blind Period	14	14
Overall Study Entered Open-label Extension Period	13	14
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Induction Dose Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
Overall Study Adverse Event	3	3
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Induction Dose n=15 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=15 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Total n=30 Participants Total of all reporting groups
Age, Continuous	33.5 years STANDARD_DEVIATION 14.60 • n=5 Participants	35.6 years STANDARD_DEVIATION 13.00 • n=7 Participants	34.5 years STANDARD_DEVIATION 13.63 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 8

Population: All participants in the intent-to-treat (ITT) population, defined as all randomized participants who received at least 1 dose of double-blind study drug, who had evaluable data.

Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.

Outcome measures

Outcome measures
Measure	Low Induction Dose n=14 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=12 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension Period) Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) Participants received open-label adalimumab 40 mg every other week for 18 weeks.
Mean Serum Adalimumab Concentration at Week 8	7.99 μg/mL Standard Deviation 3.48	10.0 μg/mL Standard Deviation 4.57	—	—

SECONDARY outcome

Timeframe: 26 weeks

Population: Safety Analysis Set: all participants who received at least 1 dose of study drug.

The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade \<3 at baseline and a post-baseline value for each parameter.

Outcome measures

Outcome measures
Measure	Low Induction Dose n=15 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=15 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension Period) Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) Participants received open-label adalimumab 40 mg every other week for 18 weeks.
Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab Haemoglobin <80 g/L (n=15,15)	1 participants	1 participants	—	—
Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab White Blood Cells ≥1 x10^9/L (n=15,15)	1 participants	0 participants	—	—
Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab Neutrophils <1.0x10^9/mcL (n=15,15)	1 participants	0 participants	—	—
Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab Lymphocytes <0.5x10^3/mcL (n=15,13)	2 participants	0 participants	—	—

SECONDARY outcome

Timeframe: From Week 0 to Week 26

Population: Safety Analysis Set.

The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized.

Outcome measures

Outcome measures
Measure	Low Induction Dose n=15 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=15 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension Period) Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) Participants received open-label adalimumab 40 mg every other week for 18 weeks.
Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab Uric Acid >500µmol/L	0 participants	1 participants	—	—
Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab Potassium <3.0 mmol/L	0 participants	1 participants	—	—
Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab Sodium <130 mmol/L	0 participants	1 participants	—	—
Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab Albumin <20 g/L	0 participants	1 participants	—	—
Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab Calcium <1.75 mmol/L	0 participants	1 participants	—	—

SECONDARY outcome

Timeframe: 26 weeks

Population: Safety Analysis Set.

Blood pressure and pulse were measured while the participant was sitting. The number of participants with a postbaseline vital sign result that meets Common Toxicity Criteria (CTC) version 3.0 (or later) Grade 3 or higher and is also more extreme than the baseline value is summarized. Terms abbreviated in the table include systolic blood pressure (SBP) and diastolic blood pressure (DBP). Increase and decrease are signified by ↑ and ↓, respectively.

Outcome measures

Outcome measures
Measure	Low Induction Dose n=15 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=15 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension Period) Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) Participants received open-label adalimumab 40 mg every other week for 18 weeks.
Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab SBP ≤90 mm Hg or ≥20 mm Hg ↓ from BL	7 participants	5 participants	—	—
Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab SBP ≥180 mm Hg or ≥20 mm Hg ↑ from BL	8 participants	3 participants	—	—
Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab DBP ≤50 mm Hg or ≥15 mm Hg ↓ from BL	3 participants	4 participants	—	—
Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab SBP ≥105 mm Hg or ≥15 mm Hg ↑ from BL	6 participants	4 participants	—	—
Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab Pulse ≤50 bpm or ≥15 bpm ↓ from BL	6 participants	7 participants	—	—
Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab Pulse SBP ≥120 bpm or ≥15 bpm ↑ from BL	7 participants	6 participants	—	—

SECONDARY outcome

Timeframe: 35 weeks

Population: Safety Analysis Set.

An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug. For more details on adverse events please see the AE section below.

Outcome measures

Outcome measures
Measure	Low Induction Dose n=15 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=15 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension Period) n=13 Participants Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) n=14 Participants Participants received open-label adalimumab 40 mg every other week for 18 weeks.
Number of Participants With Adverse Events (AEs) Any TEAE	6 participants	7 participants	7 participants	7 participants
Number of Participants With Adverse Events (AEs) Any TESAE	1 participants	1 participants	1 participants	2 participants
Number of Participants With Adverse Events (AEs) TEAE leading to discontinuation	2 participants	1 participants	1 participants	2 participants
Number of Participants With Adverse Events (AEs) Severe TEAE	0 participants	1 participants	0 participants	1 participants
Number of Participants With Adverse Events (AEs) TEAEs with reasonable possibility of being related	3 participants	6 participants	5 participants	6 participants
Number of Participants With Adverse Events (AEs) Deaths	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26

Population: ITT population.

CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.

Outcome measures

Outcome measures
Measure	Low Induction Dose n=15 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=15 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension Period) Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) Participants received open-label adalimumab 40 mg every other week for 18 weeks.
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 2	26.7 percentage of participants Interval 7.8 to 55.1	46.7 percentage of participants Interval 21.3 to 73.4	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 4	40.0 percentage of participants Interval 16.3 to 67.7	66.7 percentage of participants Interval 38.4 to 88.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 6	60.0 percentage of participants Interval 32.3 to 83.7	73.3 percentage of participants Interval 44.9 to 92.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 8	60.0 percentage of participants Interval 32.3 to 83.7	66.7 percentage of participants Interval 38.4 to 88.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 10	66.7 percentage of participants Interval 38.4 to 88.2	66.7 percentage of participants Interval 38.4 to 88.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 12	60.0 percentage of participants Interval 32.3 to 83.7	73.3 percentage of participants Interval 44.9 to 92.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 14	60.0 percentage of participants Interval 32.3 to 83.7	73.3 percentage of participants Interval 44.9 to 92.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 16	60.0 percentage of participants Interval 32.3 to 83.7	73.3 percentage of participants Interval 44.9 to 92.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 18	60.0 percentage of participants Interval 32.3 to 83.7	73.3 percentage of participants Interval 44.9 to 92.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 20	66.7 percentage of participants Interval 38.4 to 88.2	66.7 percentage of participants Interval 38.4 to 88.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 22	66.7 percentage of participants Interval 38.4 to 88.2	66.7 percentage of participants Interval 38.4 to 88.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 24	66.7 percentage of participants Interval 38.4 to 88.2	66.7 percentage of participants Interval 38.4 to 88.2	—	—
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 Week 26	66.7 percentage of participants Interval 38.4 to 88.2	66.7 percentage of participants Interval 38.4 to 88.2	—	—

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26

Population: ITT population.

Outcome measures

Outcome measures
Measure	Low Induction Dose n=15 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=15 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension Period) Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) Participants received open-label adalimumab 40 mg every other week for 18 weeks.
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 2	66.7 percentage of participants Interval 38.4 to 88.2	80.0 percentage of participants Interval 51.9 to 95.7	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 4	93.3 percentage of participants Interval 68.1 to 99.8	93.3 percentage of participants Interval 68.1 to 99.8	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 6	93.3 percentage of participants Interval 68.1 to 99.8	86.7 percentage of participants Interval 59.5 to 98.3	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 8	93.3 percentage of participants Interval 68.1 to 99.8	86.7 percentage of participants Interval 59.5 to 98.3	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 10	86.7 percentage of participants Interval 59.5 to 98.3	86.7 percentage of participants Interval 59.5 to 98.3	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 12	80.0 percentage of participants Interval 51.9 to 95.7	80.0 percentage of participants Interval 51.9 to 95.7	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 14	73.7 percentage of participants Interval 44.9 to 92.2	73.7 percentage of participants Interval 44.9 to 92.2	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 16	80.0 percentage of participants Interval 51.9 to 95.7	73.7 percentage of participants Interval 44.9 to 92.2	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 18	80.0 percentage of participants Interval 51.9 to 95.7	73.7 percentage of participants Interval 44.9 to 92.2	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 20	73.7 percentage of participants Interval 44.9 to 92.2	66.7 percentage of participants Interval 38.4 to 88.2	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 22	66.7 percentage of participants Interval 38.4 to 88.2	66.7 percentage of participants Interval 38.4 to 88.2	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 24	66.7 percentage of participants Interval 38.4 to 88.2	66.7 percentage of participants Interval 38.4 to 88.2	—	—
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 Week 26	66.7 percentage of participants Interval 38.4 to 88.2	66.7 percentage of participants Interval 38.4 to 88.2	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26

Population: ITT population.

CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. Scores range from 0 to approximately 600. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Last observation carried forward (LOCF) for missing CDAI observations was used.

Outcome measures

Outcome measures
Measure	Low Induction Dose n=15 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=15 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension Period) Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) Participants received open-label adalimumab 40 mg every other week for 18 weeks.
CDAI: Mean Change From Baseline to Each Visit Week 2	-108.91 units on a scale Standard Deviation 76.196	-143.79 units on a scale Standard Deviation 86.193	—	—
CDAI: Mean Change From Baseline to Each Visit Week 4	-152.96 units on a scale Standard Deviation 71.589	-163.21 units on a scale Standard Deviation 95.545	—	—
CDAI: Mean Change From Baseline to Each Visit Week 6	-163.53 units on a scale Standard Deviation 80.868	-178.23 units on a scale Standard Deviation 103.159	—	—
CDAI: Mean Change From Baseline to Each Visit Week 8	-181.50 units on a scale Standard Deviation 81.611	-181.87 units on a scale Standard Deviation 100.077	—	—
CDAI: Mean Change From Baseline to Each Visit Week 10	-185.24 units on a scale Standard Deviation 81.532	-182.87 units on a scale Standard Deviation 96.039	—	—
CDAI: Mean Change From Baseline to Each Visit Week 12	-200.33 units on a scale Standard Deviation 88.612	-191.09 units on a scale Standard Deviation 98.035	—	—
CDAI: Mean Change From Baseline to Each Visit Week 14	-193.63 units on a scale Standard Deviation 97.130	-194.96 units on a scale Standard Deviation 111.444	—	—
CDAI: Mean Change From Baseline to Each Visit Week 16	-198.07 units on a scale Standard Deviation 96.381	-191.37 units on a scale Standard Deviation 108.932	—	—
CDAI: Mean Change From Baseline to Each Visit Week 18	-200.17 units on a scale Standard Deviation 93.758	-188.31 units on a scale Standard Deviation 109.516	—	—
CDAI: Mean Change From Baseline to Each Visit Week 20	-214.43 units on a scale Standard Deviation 96.417	-189.83 units on a scale Standard Deviation 110.845	—	—
CDAI: Mean Change From Baseline to Each Visit Week 22	-213.95 units on a scale Standard Deviation 98.357	-194.53 units on a scale Standard Deviation 111.046	—	—
CDAI: Mean Change From Baseline to Each Visit Week 24	-215.47 units on a scale Standard Deviation 99.278	-187.98 units on a scale Standard Deviation 107.702	—	—
CDAI: Mean Change From Baseline to Each Visit Week 26	-215.79 units on a scale Standard Deviation 101.879	-200.17 units on a scale Standard Deviation 110.999	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26

Population: ITT population.

hsCRP was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 3 mg/L, slightly increasing with age. LOCF was used for missing data.

Outcome measures

Outcome measures
Measure	Low Induction Dose n=15 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=15 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension Period) Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) Participants received open-label adalimumab 40 mg every other week for 18 weeks.
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 Week 1	-7.70 mg/L Interval -74.8 to 28.1	-24.51 mg/L Interval -187.6 to -1.7	—	—
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 Week 2	-14.10 mg/L Interval -83.3 to 32.3	-25.37 mg/L Interval -184.7 to 5.3	—	—
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 Week 4	-12.05 mg/L Interval -93.2 to 42.2	-21.12 mg/L Interval -170.6 to 43.0	—	—
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 Week 6	-12.66 mg/L Interval -94.6 to 46.2	-21.61 mg/L Interval -165.9 to 18.2	—	—
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 Week 8	-11.90 mg/L Interval -98.9 to 13.0	-21.58 mg/L Interval -165.1 to 12.9	—	—
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 Week 12	-9.40 mg/L Interval -114.9 to 17.6	-15.00 mg/L Interval -188.3 to 50.5	—	—
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 Week 16	-14.00 mg/L Interval -101.1 to 0.8	-15.10 mg/L Interval -191.1 to 33.7	—	—
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 Week 20	-9.50 mg/L Interval -108.5 to 0.1	-12.80 mg/L Interval -194.2 to 21.5	—	—
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 Week 24	-12.90 mg/L Interval -112.4 to 13.7	-12.90 mg/L Interval -194.6 to 32.5	—	—
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 Week 26	-11.20 mg/L Interval -103.4 to 16.8	-6.90 mg/L Interval -194.6 to 22.5	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 4 and 8

Population: ITT population.

Stool samples for fecal calprotectin were collected before study drug administration when possible. Decreases in calprotectin are associated with decreased inflammation in the gastrointestinal tract. LOCF was used for missing data.

Outcome measures

Outcome measures
Measure	Low Induction Dose n=15 Participants Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose n=15 Participants Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension Period) Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) Participants received open-label adalimumab 40 mg every other week for 18 weeks.
Fecal Calprotectin: Change From Baseline (Week 0) to Week 8 Week 4	-135.0 μg/g Interval -1441.0 to 3397.0	-207.0 μg/g Interval -1334.0 to 3410.0	—	—
Fecal Calprotectin: Change From Baseline (Week 0) to Week 8 Week 8	-44.0 μg/g Interval -1926.0 to 5632.0	-274.0 μg/g Interval -915.0 to 6213.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Week 0) to Week 8

Population: ITT population.

Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 2 μg/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. No samples were tested because all samples had adalimumab concentrations \>2 μg/mL.

Outcome measures

Outcome data not reported

Adverse Events

Low Induction Dose (Double-blind)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Standard Induction Dose (Double-blind)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Low Induction Dose (Open-label Extension)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Standard Induction Dose (Open-label Extension)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low Induction Dose (Double-blind) n=15 participants at risk Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.	Standard Induction Dose (Double-blind) n=15 participants at risk Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.	Low Induction Dose (Open-label Extension) n=13 participants at risk Participants received open-label adalimumab 40 mg every other week for 18 weeks.	Standard Induction Dose (Open-label Extension) n=14 participants at risk Participants received open-label adalimumab 40 mg every other week for 18 weeks.
Gastrointestinal disorders CROHN'S DISEASE	6.7% 1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	6.7% 1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	0.00% 0/13 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	14.3% 2/14 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.00% 0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	6.7% 1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	0.00% 0/13 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	0.00% 0/14 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.
Infections and infestations LUNG INFECTION	0.00% 0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	6.7% 1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	0.00% 0/13 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	0.00% 0/14 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.
Infections and infestations TUBERCULOSIS GASTROINTESTINAL	0.00% 0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	6.7% 1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	0.00% 0/13 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	0.00% 0/14 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.
Investigations MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE	0.00% 0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	0.00% 0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	7.7% 1/13 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.	0.00% 0/14 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks). A TEAE in the double blind (DB) period is defined as any AE from the first dose of DB adalimumab to the first dose of open-label extension (OLE) adalimumab or 70 days after the last dose (for participants who did not enter OLE). A TEAE in the OLE period is any AE from the first dose of OLE adalimumab to 70 days after the last dose of study drug.

Other adverse events

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