Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02065570
Recruitment Status : Completed
First Posted : February 19, 2014
Results First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Drug: Adalimumab
Drug: Placebo
Enrollment 514
Recruitment Details  
Pre-assignment Details Participants were randomized in a 3:2 ratio at Baseline to receive a higher induction adalimumab regimen or standard induction adalimumab regimen during the double-blind Induction Study. At Week 12, participants were re-randomized in a 1:1 ratio to a double-blind exploratory treatment regimen (adalimumab clinically adjusted [CA] regimen or adalimumab therapeutic drug monitoring [TDM] regimen).
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose Maintenance: Clinically Adjusted (CA) Regimen Maintenance: Therapeutic Drug Monitoring (TDM) Regimen
Hide Arm/Group Description Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12. Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12. Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose could be escalated to every week (ew) starting as early as Week 14 and up to Week 54 based on Crohn's Disease Activity Index (CDAI) or high-sensitivity C-reactive protein (hs-CRP) values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing. At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Period Title: Induction Study
Started 206 308 0 0
Completed 192 287 0 0
Not Completed 14 21 0 0
Reason Not Completed
Adverse Event             5             12             0             0
Withdrawal by Subject             2             3             0             0
Lost to Follow-up             1             1             0             0
Other, Not Specified             6             5             0             0
Period Title: Maintenance Study
Started 0 0 109 109
Completed 0 0 87 90
Not Completed 0 0 22 19
Reason Not Completed
Adverse Event             0             0             8             8
Withdrawal by Subject             0             0             1             4
Lost to Follow-up             0             0             2             2
Other, Not Specified             0             0             11             5
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose Total
Hide Arm/Group Description Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12. Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12. Total of all reporting groups
Overall Number of Baseline Participants 206 308 514
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 206 participants 308 participants 514 participants
36.4  (12.79) 36.4  (13.02) 36.4  (12.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 308 participants 514 participants
Female
109
  52.9%
158
  51.3%
267
  51.9%
Male
97
  47.1%
150
  48.7%
247
  48.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 308 participants 514 participants
Hispanic or Latino
5
   2.4%
10
   3.2%
15
   2.9%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
201
  97.6%
298
  96.8%
499
  97.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 308 participants 514 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.2%
Asian
5
   2.4%
6
   1.9%
11
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
   8.7%
11
   3.6%
29
   5.6%
White
182
  88.3%
288
  93.5%
470
  91.4%
More than one race
1
   0.5%
1
   0.3%
2
   0.4%
Unknown or Not Reported
0
   0.0%
1
   0.3%
1
   0.2%
1.Primary Outcome
Title Percentage of Participants Who Achieved Clinical Remission at Week 4
Hide Description Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
43.7 43.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.939
Comments Adjusted for previous infliximab use (or prior anti-tumor necrosis factor (TNF) use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-8.1 to 8.8
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
2.Primary Outcome
Title Percentage of Participants With Endoscopic Response at Week 12
Hide Description Endoscopic response was scored using the Simplified Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score > 50% from Baseline (or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline) at Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
39.3 42.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.462
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
-5.3 to 11.7
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
3.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description Adverse event (AE): any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs: any event that began or worsened in severity after the first dose of study drug in the induction or maintenance study. Events with unknown severity were counted as severe. Events with unknown relationship to study drug were counted as drug-related.
Time Frame From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: all participants who received at least one injection of study drug.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose Maintenance: Clinically Adjusted (CA) Regimen Maintenance: Therapeutic Drug Monitoring (TDM) Regimen
Hide Arm/Group Description:
Participants were randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, and then matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.
At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Overall Number of Participants Analyzed 206 308 109 109
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
133
  64.6%
185
  60.1%
77
  70.6%
76
  69.7%
TEAE w/reasonable possibility of being related to study drug
54
  26.2%
75
  24.4%
29
  26.6%
33
  30.3%
Any severe TEAE
13
   6.3%
17
   5.5%
7
   6.4%
6
   5.5%
Any SAE
10
   4.9%
14
   4.5%
5
   4.6%
7
   6.4%
Any TEAE leading to discontinuation of study drug
8
   3.9%
13
   4.2%
8
   7.3%
9
   8.3%
Any TEAE leading to death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Deaths
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Percentage of Participants With Sustained Clinical Remission (Per CDAI) at Both Weeks 4 and 12
Hide Description CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Time Frame Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
35.0 39.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.269
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
-3.6 to 12.8
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
5.Secondary Outcome
Title Percentage of Participants Who Achieve Clinical Response at Week 4 and Endoscopic Response at Week 12
Hide Description

Clinical response was scored using CDAI, which assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from Baseline.

Endoscopic response was scored using the SES-CD, which evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score >50% from Baseline (or for Baseline SES-CD of 4, at least a 2-point reduction from Baseline) at Week 12.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
20.4 22.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.610
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-5.1 to 8.7
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
6.Secondary Outcome
Title Percentage of Participants With Clinical Remission at Week 12
Hide Description Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
51.5 62.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 11.2
Confidence Interval (2-Sided) 95%
2.9 to 19.6
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
7.Secondary Outcome
Title Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 12 Among Participants Taking Corticosteroids at Baseline
Hide Description Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Participants taking corticosteroids at Baseline.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 100 155
Measure Type: Number
Unit of Measure: percentage of participants
48.0 52.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.336
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 6.0
Confidence Interval (2-Sided) 95%
-6.2 to 18.2
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
8.Secondary Outcome
Title Percentage of Participants With Endoscopic Remission at Week 12
Hide Description Endoscopic remission was scored using the SES-CD.The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD ≤ 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
26.2 28.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.694
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-6.1 to 9.1
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
9.Secondary Outcome
Title Change From Baseline in Fecal Calprotectin Level at Week 4
Hide Description [Not Specified]
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Participants with a baseline and Week 4 assessment. Observed cases.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 152 252
Mean (Standard Deviation)
Unit of Measure: µg/g
-1045.7  (1648.51) -1157.0  (2000.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.946
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value 6.8
Confidence Interval (2-Sided) 95%
-192.3 to 205.9
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
27.7 32.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.293
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
-3.5 to 11.5
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
11.Secondary Outcome
Title Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4
Hide Description Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
11.2 14.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.304
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-2.7 to 8.6
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
12.Secondary Outcome
Title Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g and Endoscopic Remission at Week 12
Hide Description

Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.

Endoscopic remission was scored using the SES-CD.The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD ≤ 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
7.3 11.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
-0.7 to 9.1
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
13.Secondary Outcome
Title Percentage of Participants Who Achieved an SES-CD ≤ 2 at Week 12
Hide Description The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
16.0 20.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.278
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
-2.9 to 10.2
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
14.Secondary Outcome
Title Percentage of Participants With Clinical Response at Week 4
Hide Description Clinical response was scored using CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from baseline.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
70.9 74.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.353
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
-4.1 to 11.5
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
15.Secondary Outcome
Title Percentage of Participants With Clinical Response at Week 12
Hide Description Clinical response was scored using CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from Baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
74.8 83.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 8.9
Confidence Interval (2-Sided) 95%
1.8 to 16.0
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
16.Secondary Outcome
Title Percentage of Participants Achieving Response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain at Week 4
Hide Description The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 8.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
71.4 74.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.394
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
-4.4 to 11.1
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).
17.Secondary Outcome
Title Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 12
Hide Description The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 8.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
73.3 76.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.349
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
-4.0 to 11.2
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)
18.Secondary Outcome
Title Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 12
Hide Description The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: all participants who were randomized. Non-responder imputation.
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose
Hide Arm/Group Description:
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Overall Number of Participants Analyzed 206 308
Measure Type: Number
Unit of Measure: percentage of participants
68.4 76.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction: Standard Induction Dose, Induction: Higher Induction Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (<10 mg/L, >=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI > 300).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted risk difference
Estimated Value 7.6
Confidence Interval (2-Sided) 95%
-0.1 to 15.3
Estimation Comments Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)
Time Frame From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Induction: Standard Induction Dose Induction: Higher Induction Dose Maintenance: Clinically Adjusted (CA) Regimen Maintenance: Therapeutic Drug Management (TDM) Regimen
Hide Arm/Group Description Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12. Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12. Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing. At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
All-Cause Mortality
Induction: Standard Induction Dose Induction: Higher Induction Dose Maintenance: Clinically Adjusted (CA) Regimen Maintenance: Therapeutic Drug Management (TDM) Regimen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/206 (0.00%)      0/308 (0.00%)      0/109 (0.00%)      0/109 (0.00%)    
Hide Serious Adverse Events
Induction: Standard Induction Dose Induction: Higher Induction Dose Maintenance: Clinically Adjusted (CA) Regimen Maintenance: Therapeutic Drug Management (TDM) Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/206 (4.85%)      14/308 (4.55%)      5/109 (4.59%)      7/109 (6.42%)    
Eye disorders         
SCLERITIS  1  0/206 (0.00%)  0 0/308 (0.00%)  0 0/109 (0.00%)  0 1/109 (0.92%)  1
UVEITIS  1  0/206 (0.00%)  0 0/308 (0.00%)  0 0/109 (0.00%)  0 1/109 (0.92%)  1
Gastrointestinal disorders         
ABDOMINAL PAIN  1  1/206 (0.49%)  1 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
CROHN'S DISEASE  1  3/206 (1.46%)  3 3/308 (0.97%)  3 2/109 (1.83%)  2 1/109 (0.92%)  1
FAECALOMA  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
GASTROINTESTINAL INFLAMMATION  1  1/206 (0.49%)  1 0/308 (0.00%)  0 0/109 (0.00%)  0 0/109 (0.00%)  0
INTESTINAL HAEMORRHAGE  1  0/206 (0.00%)  0 0/308 (0.00%)  0 0/109 (0.00%)  0 1/109 (0.92%)  1
INTESTINAL OBSTRUCTION  1  0/206 (0.00%)  0 2/308 (0.65%)  2 1/109 (0.92%)  1 0/109 (0.00%)  0
LARGE INTESTINAL STENOSIS  1  1/206 (0.49%)  1 0/308 (0.00%)  0 0/109 (0.00%)  0 0/109 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  1/206 (0.49%)  2 0/308 (0.00%)  0 1/109 (0.92%)  1 0/109 (0.00%)  0
SUBILEUS  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
Infections and infestations         
ABDOMINAL ABSCESS  1  1/206 (0.49%)  1 0/308 (0.00%)  0 0/109 (0.00%)  0 0/109 (0.00%)  0
ABSCESS LIMB  1  1/206 (0.49%)  1 0/308 (0.00%)  0 0/109 (0.00%)  0 0/109 (0.00%)  0
ACQUIRED IMMUNODEFICIENCY SYNDROME  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
CELLULITIS  1  1/206 (0.49%)  1 0/308 (0.00%)  0 0/109 (0.00%)  0 0/109 (0.00%)  0
INFECTIOUS MONONUCLEOSIS  1  0/206 (0.00%)  0 0/308 (0.00%)  0 0/109 (0.00%)  0 1/109 (0.92%)  1
INTESTINAL TUBERCULOSIS  1  1/206 (0.49%)  1 0/308 (0.00%)  0 0/109 (0.00%)  0 0/109 (0.00%)  0
PNEUMOCYSTIS JIROVECII PNEUMONIA  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
PYELONEPHRITIS  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
SEPSIS  1  0/206 (0.00%)  0 0/308 (0.00%)  0 0/109 (0.00%)  0 1/109 (0.92%)  1
URINARY TRACT INFECTION  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 1/109 (0.92%)  1
VARICELLA  1  0/206 (0.00%)  0 0/308 (0.00%)  0 0/109 (0.00%)  0 1/109 (0.92%)  1
Injury, poisoning and procedural complications         
CLAVICLE FRACTURE  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
HIP FRACTURE  1  0/206 (0.00%)  0 0/308 (0.00%)  0 1/109 (0.92%)  1 0/109 (0.00%)  0
RADIUS FRACTURE  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
ROAD TRAFFIC ACCIDENT  1  0/206 (0.00%)  0 1/308 (0.32%)  1 1/109 (0.92%)  1 0/109 (0.00%)  0
TRAUMATIC LIVER INJURY  1  0/206 (0.00%)  0 0/308 (0.00%)  0 1/109 (0.92%)  1 0/109 (0.00%)  0
Metabolism and nutrition disorders         
HYPOKALAEMIA  1  1/206 (0.49%)  1 0/308 (0.00%)  0 0/109 (0.00%)  0 0/109 (0.00%)  0
HYPOVOLAEMIA  1  1/206 (0.49%)  1 0/308 (0.00%)  0 0/109 (0.00%)  0 0/109 (0.00%)  0
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
BACK PAIN  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
PAPILLARY RENAL CELL CARCINOMA  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
Nervous system disorders         
AMNESIA  1  1/206 (0.49%)  1 0/308 (0.00%)  0 0/109 (0.00%)  0 0/109 (0.00%)  0
CEREBRAL INFARCTION  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
Psychiatric disorders         
DEPRESSION  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 1/109 (0.92%)  1
SUICIDAL IDEATION  1  0/206 (0.00%)  0 0/308 (0.00%)  0 0/109 (0.00%)  0 1/109 (0.92%)  1
Renal and urinary disorders         
HYDRONEPHROSIS  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
NEPHROLITHIASIS  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
Skin and subcutaneous tissue disorders         
DRUG ERUPTION  1  0/206 (0.00%)  0 0/308 (0.00%)  0 0/109 (0.00%)  0 1/109 (0.92%)  1
Surgical and medical procedures         
SELECTIVE ABORTION  1  0/206 (0.00%)  0 1/308 (0.32%)  1 0/109 (0.00%)  0 0/109 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Induction: Standard Induction Dose Induction: Higher Induction Dose Maintenance: Clinically Adjusted (CA) Regimen Maintenance: Therapeutic Drug Management (TDM) Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/206 (26.21%)      58/308 (18.83%)      41/109 (37.61%)      33/109 (30.28%)    
Gastrointestinal disorders         
CROHN'S DISEASE  1  12/206 (5.83%)  14 14/308 (4.55%)  15 16/109 (14.68%)  20 15/109 (13.76%)  17
DIARRHOEA  1  3/206 (1.46%)  3 2/308 (0.65%)  2 6/109 (5.50%)  7 4/109 (3.67%)  4
NAUSEA  1  15/206 (7.28%)  17 9/308 (2.92%)  10 5/109 (4.59%)  7 3/109 (2.75%)  3
Infections and infestations         
NASOPHARYNGITIS  1  9/206 (4.37%)  11 19/308 (6.17%)  21 15/109 (13.76%)  15 10/109 (9.17%)  12
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  16/206 (7.77%)  19 10/308 (3.25%)  10 8/109 (7.34%)  8 4/109 (3.67%)  5
Nervous system disorders         
DIZZINESS  1  11/206 (5.34%)  13 2/308 (0.65%)  2 0/109 (0.00%)  0 0/109 (0.00%)  0
HEADACHE  1  18/206 (8.74%)  24 17/308 (5.52%)  19 9/109 (8.26%)  9 8/109 (7.34%)  18
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02065570    
Other Study ID Numbers: M14-115
2013-001746-33 ( EudraCT Number )
First Submitted: February 17, 2014
First Posted: February 19, 2014
Results First Submitted: January 20, 2021
Results First Posted: February 18, 2021
Last Update Posted: February 18, 2021