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Efficacy and Safety of Adalimumab in Pediatric 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: NCT00409682
Recruitment Status : Completed
First Posted : December 11, 2006
Results First Posted : August 4, 2011
Last Update Posted : August 4, 2011
Sponsor:
Information provided by:
Abbott

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
Intervention Biological: Adalimumab
Enrollment 192
Recruitment Details Subjects were enrolled at 45 investigative sites in the US, Canada, and Europe. A total of 192 subjects received at least one dose of adalimumab and participated in the 4-week Open-label induction period of the study. Of these, 4 discontinued and 188 subjects participated in the DB Maintenance period.
Pre-assignment Details Enrolled pediatric subjects were given an induction regimen of 160/80 mg adalimumab at Baseline/Week 2 or 80/40 mg at Baseline/Week 2 according to the subjects' Baseline body weight (BW) and were randomized at Week 4 to receive one of two maintenance regimens of adalimumab every other week (eow).
Arm/Group Title Open-label Adalimumab (Week 0 to Week 4) Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Hide Arm/Group Description All subjects received an open-label adalimumab induction regimen. Subjects weighing ≥ 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing < 40 kg at Baseline received 80 mg at Week 0 and 40 mg at Week 2. Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 10 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy. Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 20 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
Period Title: Open-label Induction Period
Started 192 0 0
Completed 188 0 0
Not Completed 4 0 0
Reason Not Completed
Adverse Event             1             0             0
Lack of Efficacy             1             0             0
Protocol Violation             1             0             0
Subject did not satisfy entry criteria             1             0             0
Period Title: EOW Double-blind Maintenance Period
Started 0 95 93
Completed 0 58 66
Not Completed 0 37 27
Reason Not Completed
Adverse Event             0             10             12
Lack of Efficacy             0             18             11
Lost to Follow-up             0             1             0
Withdrawal by Subject             0             4             2
Protocol Violation             0             4             1
Non-compliance             0             0             1
Arm/Group Title Open-label Adalimumab (Week 0 to Week 4) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52) Low-Dose Adalimumab: 20 mg or 10 mg (Week 4 to Week 52) Total
Hide Arm/Group Description All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2. Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy. Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy. Total of all reporting groups
Overall Number of Baseline Participants 0 93 95 188
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 93 participants 95 participants 188 participants
0  (0) 13.7  (2.52) 13.5  (2.47) 13.6  (2.49)
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 0 participants 93 participants 95 participants 188 participants
< 13 0 31 35 66
>= 13 0 62 60 122
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 93 participants 95 participants 188 participants
Female 0
42
  45.2%
41
  43.2%
83
  44.1%
Male 0
51
  54.8%
54
  56.8%
105
  55.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 93 participants 95 participants 188 participants
White 0 81 85 166
Black 0 5 6 11
Asian 0 3 0 3
American Indian/Alaska Native 0 0 0 0
Native Hawaiian or other Pacific Islander 0 0 0 0
Mult-race 0 1 2 3
Other 0 3 2 5
Weight  
Measure Type: Number
Unit of measure:  Kg
Number Analyzed 0 participants 93 participants 95 participants 188 participants
< 40 0 32 35 67
>= 40 0 61 60 121
1.Primary Outcome
Title Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26
Hide Description Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The primary endpoint was clinical remission as defined by PCDAI score ≤ 10. The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to-treat population.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Comparison of adalimumab High-Dose versus Low-Dose with respect to the primary efficacy endpoint in the intent-to-treat analysis set as all randomized subjects who received at least one dose of double-blind study medication.
Arm/Group Title Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Hide Arm/Group Description:
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
Overall Number of Participants Analyzed 95 93
Measure Type: Number
Unit of Measure: percent of participants
28.4 38.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52), High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Comments The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The P value is from the CMH test adjusted for infliximab use and response status at Week 4. The primary analysis was performed for the intent-to-treat (ITT) using the non-responder (NRI) imputation method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments There is no adjustment for multiple comparison on the primary outcome measure.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 10.29
Confidence Interval (2-Sided) 95%
-3.14 to 23.71
Estimation Comments Difference is between adalimumab High-dose and adalimumab Low-dose group.
2.Secondary Outcome
Title Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 52
Hide Description

Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100 with higher scores indicating more active disease. Clinical remission was defined as PCDAI score of ≤ 10.

The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to treat population.

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population using non-responder imputation method.
Arm/Group Title Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Hide Arm/Group Description:
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
Overall Number of Participants Analyzed 95 93
Measure Type: Number
Unit of Measure: percent of participants
23.2 33.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52), High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Comments The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% CIs for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 10.18
Confidence Interval (2-Sided) 95%
-2.62 to 22.97
Estimation Comments A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.
3.Secondary Outcome
Title Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 26
Hide Description Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population using non-responder imputation (NRI) method.
Arm/Group Title Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Hide Arm/Group Description:
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
Overall Number of Participants Analyzed 95 93
Measure Type: Number
Unit of Measure: percent of participants
48.4 59.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52), High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Comments The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 10.72
Confidence Interval (2-Sided) 95%
-3.45 to 24.89
Estimation Comments A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.
4.Secondary Outcome
Title Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 52
Hide Description Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population using non-responder imputation (NRI) method.
Arm/Group Title Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Hide Arm/Group Description:
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
Overall Number of Participants Analyzed 95 93
Measure Type: Number
Unit of Measure: percent of participants
28.4 41.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52), High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Comments The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 13.51
Confidence Interval (2-Sided) 95%
-0.01 to 27.04
Estimation Comments A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.
5.Secondary Outcome
Title Change From Baseline IMPACT III Scores at Week 26 (Observed Case)
Hide Description The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease [CD] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population for observed case (OC).
Arm/Group Title Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Hide Arm/Group Description:
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
Overall Number of Participants Analyzed 48 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
26.40  (15.589) 23.70  (18.990)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52), High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Comments

Analyzed as change from Baseline to Week 26, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% CI for the treatment difference were provided. Analysis was conducted in the ITT population for OC.

The P value is from the ANCOVA model with treatment as a factor, adjusted for the baseline value, and the strata (response status at Week 4 and prior infliximab experience).

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.10
Confidence Interval (2-Sided) 95%
-9.86 to 1.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.903
Estimation Comments Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.
6.Secondary Outcome
Title Change From Baseline IMPACT III Scores at Week 52 (Observed Case)
Hide Description The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease [CD] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population for observed case (OC).
Arm/Group Title Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Hide Arm/Group Description:
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
Overall Number of Participants Analyzed 31 38
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
26.49  (16.182) 24.25  (14.678)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52), High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Comments Analyzed as change from Baseline to Week 52, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% confidence interval (CI) for the treatment difference were provided. Analysis was conducted in the ITT population for OC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.735
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.00
Confidence Interval (2-Sided) 95%
-6.88 to 4.88
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.941
Estimation Comments Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.
Time Frame All adverse events (AEs) reported from the time of study drug administration until 70 days after discontinuation of study drug were collected. Serious AEs were collected from the time the subject or parent/legal guardian signed the informed consent.
Adverse Event Reporting Description Open-label (OL) Adalimumab (Wk 0 - Wk 4): AEs from first OL dose to 70 days after last OL induction adalimumab dose or until first double-blind (DB) dose Low-Dose/High-Dose Adalimumab (Wk 4 - Wk 52): AEs from first DB dose to 70 days after last DB every other week (eow) or until switch to every week (ew) dosing or OL extension
 
Arm/Group Title Open-label Adalimumab (Week 0 to Week 4) Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Open-label Adalimumab (Week 0 to Week 4) Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Open-label Adalimumab (Week 0 to Week 4) Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/192 (3.13%)   19/95 (20.00%)   22/93 (23.66%) 
Blood and lymphatic system disorders       
ANAEMIA  1  0/192 (0.00%)  0/95 (0.00%)  4/93 (4.30%) 
Gastrointestinal disorders       
CROHN'S DISEASE  1  2/192 (1.04%)  15/95 (15.79%)  12/93 (12.90%) 
INFLAMMATORY BOWEL DISEASE  1  1/192 (0.52%)  0/95 (0.00%)  0/93 (0.00%) 
PANCREATITIS ACUTE  1  0/192 (0.00%)  1/95 (1.05%)  0/93 (0.00%) 
SMALL INTESTINAL OBSTRUCTION  1  0/192 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
Infections and infestations       
ABDOMINAL ABSCESS  1  0/192 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
ANAL ABSCESS  1  0/192 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
BARTHOLIN'S ABSCESS  1  0/192 (0.00%)  1/95 (1.05%)  0/93 (0.00%) 
GASTROENTERITIS  1  0/192 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
H1N1 INFLUENZA  1  0/192 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
HISTOPLASMOSIS DISSEMINATED  1  0/192 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
SCARLET FEVER  1  0/192 (0.00%)  1/95 (1.05%)  0/93 (0.00%) 
TOOTH ABSCESS  1  0/192 (0.00%)  1/95 (1.05%)  0/93 (0.00%) 
VIRAL INFECTION  1  1/192 (0.52%)  0/95 (0.00%)  0/93 (0.00%) 
YERSINIA INFECTION  1  1/192 (0.52%)  0/95 (0.00%)  0/93 (0.00%) 
Injury, poisoning and procedural complications       
FACIAL BONES FRACTURE  1  0/192 (0.00%)  1/95 (1.05%)  0/93 (0.00%) 
Investigations       
HEART RATE IRREGULAR  1  1/192 (0.52%)  0/95 (0.00%)  0/93 (0.00%) 
Psychiatric disorders       
PSYCHOSOMATIC DISEASE  1  0/192 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-label Adalimumab (Week 0 to Week 4) Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52) High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   64/192 (33.33%)   62/95 (65.26%)   69/93 (74.19%) 
Blood and lymphatic system disorders       
LYMPHADENOPATHY  1  0/192 (0.00%)  6/95 (6.32%)  3/93 (3.23%) 
Gastrointestinal disorders       
ABDOMINAL PAIN  1  5/192 (2.60%)  6/95 (6.32%)  9/93 (9.68%) 
ABDOMINAL PAIN UPPER  1  2/192 (1.04%)  3/95 (3.16%)  7/93 (7.53%) 
CROHN'S DISEASE  1  5/192 (2.60%)  15/95 (15.79%)  11/93 (11.83%) 
DIARRHOEA  1  3/192 (1.56%)  9/95 (9.47%)  8/93 (8.60%) 
NAUSEA  1  9/192 (4.69%)  6/95 (6.32%)  10/93 (10.75%) 
VOMITING  1  3/192 (1.56%)  10/95 (10.53%)  6/93 (6.45%) 
General disorders       
FATIGUE  1  3/192 (1.56%)  4/95 (4.21%)  5/93 (5.38%) 
INJECTION SITE PAIN  1  12/192 (6.25%)  4/95 (4.21%)  2/93 (2.15%) 
INJECTION SITE REACTION  1  10/192 (5.21%)  4/95 (4.21%)  5/93 (5.38%) 
PAIN  1  2/192 (1.04%)  2/95 (2.11%)  5/93 (5.38%) 
PYREXIA  1  1/192 (0.52%)  8/95 (8.42%)  10/93 (10.75%) 
Infections and infestations       
NASOPHARYNGITIS  1  3/192 (1.56%)  11/95 (11.58%)  9/93 (9.68%) 
PHARYNGITIS  1  2/192 (1.04%)  2/95 (2.11%)  7/93 (7.53%) 
PHARYNGITIS STREPTOCOCCAL  1  0/192 (0.00%)  5/95 (5.26%)  2/93 (2.15%) 
UPPER RESPIRATORY TRACT INFECTION  1  5/192 (2.60%)  10/95 (10.53%)  10/93 (10.75%) 
VIRAL INFECTION  1  0/192 (0.00%)  6/95 (6.32%)  4/93 (4.30%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  6/192 (3.13%)  3/95 (3.16%)  5/93 (5.38%) 
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  0/192 (0.00%)  5/95 (5.26%)  2/93 (2.15%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  4/192 (2.08%)  4/95 (4.21%)  8/93 (8.60%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
SKIN PAPILLOMA  1  1/192 (0.52%)  3/95 (3.16%)  5/93 (5.38%) 
Nervous system disorders       
DIZZINESS  1  2/192 (1.04%)  5/95 (5.26%)  1/93 (1.08%) 
HEADACHE  1  9/192 (4.69%)  20/95 (21.05%)  16/93 (17.20%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  0/192 (0.00%)  7/95 (7.37%)  9/93 (9.68%) 
OROPHARYNGEAL PAIN  1  3/192 (1.56%)  8/95 (8.42%)  9/93 (9.68%) 
RHINORRHOEA  1  1/192 (0.52%)  8/95 (8.42%)  3/93 (3.23%) 
Skin and subcutaneous tissue disorders       
RASH  1  0/192 (0.00%)  5/95 (5.26%)  5/93 (5.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
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Responsible Party: Andreas Lazar, Abbott
ClinicalTrials.gov Identifier: NCT00409682    
Other Study ID Numbers: M06-806
2006-004814-41 ( EudraCT Number )
First Submitted: December 8, 2006
First Posted: December 11, 2006
Results First Submitted: May 18, 2011
Results First Posted: August 4, 2011
Last Update Posted: August 4, 2011