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Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806

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ClinicalTrials.gov Identifier: NCT00686374
Recruitment Status : Completed
First Posted : May 29, 2008
Results First Posted : April 20, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn's Disease
Intervention Biological: Adalimumab
Enrollment 100
Recruitment Details  
Pre-assignment Details 36 participants discontinued study drug when adalimumab became commercially available (received regulatory approval for pediatric Crohn's disease) in their country. These participants were considered to have completed the study, and are included as study completers in the subject disposition.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Period Title: Overall Study
Started 100
Completed 39
Not Completed 61
Reason Not Completed
Lack of Efficacy             10
Adverse Event             8
Withdrew consent             5
Lost to Follow-up             1
Missing reason             33
Other, not specified             4
Arm/Group Title Any Adalimumab
Hide Arm/Group Description Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
13.5  (2.5)
[1]
Measure Description: Age at Study M06-806 Baseline
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female 48
Male 52
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
White 93
Black 3
Other 2
Multi-race 2
Body weight at Study M06-806 Baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
< 40 kg 38
≥ 40 kg 62
1.Primary Outcome
Title Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time
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. Clinical remission was defined as PCDAI ≤ 10.
Time Frame Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 100 participants
67
Week 4 Number Analyzed 98 participants
65
Week 8 Number Analyzed 97 participants
67
Week 12 Number Analyzed 96 participants
60
Week 24 Number Analyzed 94 participants
59
Week 36 Number Analyzed 87 participants
60
Week 48 Number Analyzed 82 participants
54
Week 60 Number Analyzed 79 participants
60
Week 72 Number Analyzed 76 participants
49
Week 84 Number Analyzed 74 participants
54
Week 96 Number Analyzed 77 participants
54
Week 108 Number Analyzed 72 participants
54
Week 120 Number Analyzed 67 participants
52
Week 144 Number Analyzed 64 participants
51
Week 168 Number Analyzed 58 participants
44
Week 192 Number Analyzed 55 participants
44
Week 216 Number Analyzed 50 participants
36
Week 240 Number Analyzed 46 participants
37
Week 264 Number Analyzed 37 participants
31
Week 288 Number Analyzed 29 participants
24
Week 312 Number Analyzed 18 participants
14
Week 336 Number Analyzed 11 participants
8
Week 360 Number Analyzed 8 participants
7
Week 384 Number Analyzed 2 participants
2
Week 408 Number Analyzed 0 participants
2.Primary Outcome
Title Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time
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 baseline PCDAI value was defined as the last non-missing value on or before the date of the first dose of study drug during Study M06-806. Clinical response was defined as a PCDAI ≥ 15 points lower than the Study M06-806 baseline PCDAI value.
Time Frame Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 100 participants
95
Week 4 Number Analyzed 98 participants
90
Week 8 Number Analyzed 97 participants
92
Week 12 Number Analyzed 96 participants
87
Week 24 Number Analyzed 94 participants
88
Week 36 Number Analyzed 87 participants
82
Week 48 Number Analyzed 82 participants
74
Week 60 Number Analyzed 79 participants
76
Week 72 Number Analyzed 76 participants
72
Week 84 Number Analyzed 74 participants
69
Week 96 Number Analyzed 77 participants
72
Week 108 Number Analyzed 72 participants
70
Week 120 Number Analyzed 67 participants
65
Week 144 Number Analyzed 64 participants
64
Week 168 Number Analyzed 58 participants
53
Week 192 Number Analyzed 55 participants
52
Week 216 Number Analyzed 50 participants
46
Week 240 Number Analyzed 46 participants
43
Week 264 Number Analyzed 37 participants
35
Week 288 Number Analyzed 29 participants
28
Week 312 Number Analyzed 18 participants
15
Week 336 Number Analyzed 11 participants
10
Week 360 Number Analyzed 8 participants
8
Week 384 Number Analyzed 2 participants
2
Week 408 Number Analyzed 0 participants
3.Secondary Outcome
Title Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time
Hide Description The CDAI includes 8 variables encompassing both subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, participants kept track of daily symptoms on a diary card, and the daily symptom scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease. A CDAI was calculated at each visit for participants who were age 13 or older at Study M06-806 entry. The Study M06-806 Week 52 visit served as the baseline visit for this study.
Time Frame Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Number of Participants Analyzed 65
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 65 participants
58
Week 4 Number Analyzed 63 participants
55
Week 8 Number Analyzed 62 participants
58
Week 12 Number Analyzed 61 participants
53
Week 24 Number Analyzed 59 participants
54
Week 36 Number Analyzed 55 participants
52
Week 48 Number Analyzed 53 participants
48
Week 60 Number Analyzed 52 participants
49
Week 72 Number Analyzed 50 participants
47
Week 84 Number Analyzed 50 participants
46
Week 96 Number Analyzed 50 participants
45
Week 108 Number Analyzed 49 participants
45
Week 120 Number Analyzed 43 participants
42
Week 144 Number Analyzed 41 participants
40
Week 168 Number Analyzed 35 participants
35
Week 192 Number Analyzed 33 participants
31
Week 216 Number Analyzed 30 participants
27
Week 240 Number Analyzed 29 participants
26
Week 264 Number Analyzed 24 participants
23
Week 288 Number Analyzed 18 participants
17
Week 312 Number Analyzed 15 participants
15
Week 336 Number Analyzed 9 participants
8
Week 360 Number Analyzed 7 participants
7
Week 384 Number Analyzed 1 participants
1
Week 408 Number Analyzed 0 participants
4.Secondary Outcome
Title Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time
Hide Description The CDAI includes 8 variables: subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight). Participants kept track of symptoms on a diary card, and scores were summed for the week. Each item is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. Scale: < 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease), and > 450 (severely active disease). A CDAI was calculated at each visit for participants ≥ 13 yrs old at M06-806 entry. Clinical response was defined as a decrease from M06-806 Baseline CDAI value of ≥ 70 pts. The M06-806 Baseline value was defined as the last non-missing value on or before the date of the 1st dose of study drug in M06-806.
Time Frame Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Number of Participants Analyzed 64
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 64 participants
55
Week 4 Number Analyzed 63 participants
56
Week 8 Number Analyzed 62 participants
56
Week 12 Number Analyzed 61 participants
51
Week 24 Number Analyzed 59 participants
52
Week 36 Number Analyzed 55 participants
53
Week 48 Number Analyzed 53 participants
48
Week 60 Number Analyzed 52 participants
48
Week 72 Number Analyzed 50 participants
45
Week 84 Number Analyzed 50 participants
47
Week 96 Number Analyzed 50 participants
45
Week 108 Number Analyzed 49 participants
47
Week 120 Number Analyzed 43 participants
40
Week 144 Number Analyzed 41 participants
41
Week 168 Number Analyzed 35 participants
34
Week 192 Number Analyzed 33 participants
33
Week 216 Number Analyzed 30 participants
28
Week 240 Number Analyzed 29 participants
28
Week 264 Number Analyzed 24 participants
24
Week 288 Number Analyzed 18 participants
18
Week 312 Number Analyzed 15 participants
15
Week 336 Number Analyzed 9 participants
9
Week 360 Number Analyzed 7 participants
7
Week 384 Number Analyzed 1 participants
1
Week 408 Number Analyzed 0 participants
5.Secondary Outcome
Title Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time
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. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.
Time Frame Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with corticosteroid use at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 37 participants
23
Week 4 Number Analyzed 37 participants
23
Week 8 Number Analyzed 37 participants
23
Week 12 Number Analyzed 37 participants
20
Week 24 Number Analyzed 37 participants
21
Week 36 Number Analyzed 33 participants
19
Week 48 Number Analyzed 32 participants
19
Week 60 Number Analyzed 30 participants
24
Week 72 Number Analyzed 28 participants
17
Week 84 Number Analyzed 29 participants
19
Week 96 Number Analyzed 29 participants
20
Week 108 Number Analyzed 27 participants
18
Week 120 Number Analyzed 25 participants
19
Week 144 Number Analyzed 24 participants
17
Week 168 Number Analyzed 22 participants
16
Week 192 Number Analyzed 19 participants
15
Week 216 Number Analyzed 19 participants
13
Week 240 Number Analyzed 16 participants
13
Week 264 Number Analyzed 13 participants
11
Week 288 Number Analyzed 10 participants
9
Week 312 Number Analyzed 5 participants
5
Week 336 Number Analyzed 3 participants
2
Week 360 Number Analyzed 2 participants
1
Week 384 Number Analyzed 0 participants
6.Secondary Outcome
Title Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time
Hide Description The CDAI includes 8 variables encompassing subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. Participants kept track of daily symptoms on a diary card, and the scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: < 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease), and > 450 (severely active disease). A CDAI was calculated at each visit for subjects ≥ 13 years old at M06-806 entry. CDAI corticosteroid-free remission was defined as discontinued use at least 90 consecutive days prior to the respective visit and a CDAI < 150 at that visit.
Time Frame Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥ 13 years old with corticosteroid use at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 26 participants
21
Week 4 Number Analyzed 26 participants
22
Week 8 Number Analyzed 26 participants
22
Week 12 Number Analyzed 26 participants
20
Week 24 Number Analyzed 26 participants
21
Week 36 Number Analyzed 24 participants
22
Week 48 Number Analyzed 24 participants
22
Week 60 Number Analyzed 23 participants
21
Week 72 Number Analyzed 21 participants
19
Week 84 Number Analyzed 22 participants
20
Week 96 Number Analyzed 22 participants
20
Week 108 Number Analyzed 21 participants
18
Week 120 Number Analyzed 18 participants
16
Week 144 Number Analyzed 17 participants
15
Week 168 Number Analyzed 14 participants
13
Week 192 Number Analyzed 12 participants
11
Week 216 Number Analyzed 13 participants
10
Week 240 Number Analyzed 11 participants
10
Week 264 Number Analyzed 8 participants
8
Week 288 Number Analyzed 6 participants
6
Week 312 Number Analyzed 4 participants
4
Week 336 Number Analyzed 3 participants
2
Week 360 Number Analyzed 2 participants
1
Week 384 Number Analyzed 0 participants
7.Secondary Outcome
Title Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time
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 baseline value was defined as the last non-missing value on or before the date of the first dose of study drug in Study M06-806. Negative changes indicate reductions (improvement) in disease activity.
Time Frame Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 Number Analyzed 100 participants
-29.95  (11.459)
Week 4 Number Analyzed 98 participants
-30.15  (11.514)
Week 8 Number Analyzed 97 participants
-30.7  (11.415)
Week 12 Number Analyzed 96 participants
-29.19  (11.405)
Week 24 Number Analyzed 94 participants
-29.84  (11.702)
Week 36 Number Analyzed 87 participants
-30.89  (12.354)
Week 48 Number Analyzed 82 participants
-30.73  (11.983)
Week 60 Number Analyzed 79 participants
-32.78  (10.927)
Week 72 Number Analyzed 76 participants
-31.15  (10.404)
Week 84 Number Analyzed 74 participants
-32.94  (10.809)
Week 96 Number Analyzed 77 participants
-31.14  (11.33)
Week 108 Number Analyzed 72 participants
-33.54  (9.538)
Week 120 Number Analyzed 67 participants
-33.36  (10.441)
Week 144 Number Analyzed 64 participants
-34.38  (9.204)
Week 168 Number Analyzed 58 participants
-32.57  (11.273)
Week 192 Number Analyzed 55 participants
-33.00  (13.258)
Week 216 Number Analyzed 50 participants
-31.95  (12.344)
Week 240 Number Analyzed 46 participants
-34.18  (13.386)
Week 264 Number Analyzed 37 participants
-35.00  (9.242)
Week 288 Number Analyzed 29 participants
-35.95  (11.941)
Week 312 Number Analyzed 18 participants
-33.19  (14.318)
Week 336 Number Analyzed 11 participants
-35.23  (12.013)
Week 360 Number Analyzed 8 participants
-38.75  (10.69)
Week 384 Number Analyzed 2 participants
-46.25  (22.981)
8.Secondary Outcome
Title Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time
Hide Description The CDAI includes 8 variables: participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. Participants kept track of daily symptoms on a diary card, and the scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: < 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease) and > 450 (severely active disease). A CDAI was calculated at each visit for those who were ≥ 13 years old at Study M06-806 entry. The baseline value was defined as the last non-missing value on or before the date of the first dose of study drug in Study M06-806. Negative changes indicate reductions (improvement) in disease activity.
Time Frame Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 Number Analyzed 64 participants
-160.8  (82.543)
Week 4 Number Analyzed 63 participants
-159.9  (79.986)
Week 8 Number Analyzed 62 participants
-164.45  (79.272)
Week 12 Number Analyzed 61 participants
-151.34  (87.157)
Week 24 Number Analyzed 59 participants
-161.51  (84.663)
Week 36 Number Analyzed 55 participants
-173.55  (77.358)
Week 48 Number Analyzed 53 participants
-162.08  (86.292)
Week 60 Number Analyzed 52 participants
-168.27  (82.605)
Week 72 Number Analyzed 50 participants
-165.4  (80.038)
Week 84 Number Analyzed 50 participants
-172.68  (86.223)
Week 96 Number Analyzed 50 participants
-168.3  (79.658)
Week 108 Number Analyzed 49 participants
-171.63  (85.19)
Week 120 Number Analyzed 43 participants
-179.14  (86.93)
Week 144 Number Analyzed 41 participants
-181.53  (78.99)
Week 168 Number Analyzed 35 participants
-175.05  (80.965)
Week 192 Number Analyzed 33 participants
-172.42  (76.381)
Week 216 Number Analyzed 30 participants
-173.13  (78.588)
Week 240 Number Analyzed 29 participants
-184.46  (94.114)
Week 264 Number Analyzed 24 participants
-186.42  (75.396)
Week 288 Number Analyzed 18 participants
-197.11  (88.029)
Week 312 Number Analyzed 15 participants
-199.00  (77.184)
Week 336 Number Analyzed 9 participants
-240.33  (97.395)
Week 360 Number Analyzed 7 participants
-224.86  (89.025)
Week 384 Number Analyzed 1 participants
-458.00
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks).
Adverse Event Reporting Description TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title Any Adalimumab
Hide Arm/Group Description Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
All-Cause Mortality
Any Adalimumab
Affected / at Risk (%)
Total   0/100 (0.00%) 
Hide Serious Adverse Events
Any Adalimumab
Affected / at Risk (%)
Total   48/100 (48.00%) 
Blood and lymphatic system disorders   
ANAEMIA  1  2/100 (2.00%) 
LYMPHADENITIS  1  1/100 (1.00%) 
Ear and labyrinth disorders   
VERTIGO  1  1/100 (1.00%) 
Gastrointestinal disorders   
ABDOMINAL PAIN  1  1/100 (1.00%) 
ABDOMINAL PAIN UPPER  1  1/100 (1.00%) 
COLITIS ULCERATIVE  1  1/100 (1.00%) 
CONSTIPATION  1  1/100 (1.00%) 
CROHN'S DISEASE  1  25/100 (25.00%) 
FAECAL VOLUME INCREASED  1  1/100 (1.00%) 
GASTRITIS  1  2/100 (2.00%) 
GASTROINTESTINAL PAIN  1  1/100 (1.00%) 
ILEAL PERFORATION  1  1/100 (1.00%) 
ILEAL STENOSIS  1  1/100 (1.00%) 
LARGE INTESTINAL STENOSIS  1  1/100 (1.00%) 
LARGE INTESTINE PERFORATION  1  1/100 (1.00%) 
OESOPHAGITIS  1  1/100 (1.00%) 
PANCREATITIS ACUTE  1  1/100 (1.00%) 
SMALL INTESTINAL STENOSIS  1  1/100 (1.00%) 
STOMATITIS  1  1/100 (1.00%) 
General disorders   
FATIGUE  1  1/100 (1.00%) 
PYREXIA  1  1/100 (1.00%) 
Hepatobiliary disorders   
HEPATITIS  1  1/100 (1.00%) 
Infections and infestations   
ABDOMINAL ABSCESS  1  1/100 (1.00%) 
ANAL ABSCESS  1  3/100 (3.00%) 
CYSTITIS VIRAL  1  1/100 (1.00%) 
GASTROENTERITIS  1  2/100 (2.00%) 
HERPES VIRUS INFECTION  1  1/100 (1.00%) 
IMPETIGO  1  1/100 (1.00%) 
PELVIC ABSCESS  1  1/100 (1.00%) 
PERIRECTAL ABSCESS  1  1/100 (1.00%) 
PERITONITIS  1  1/100 (1.00%) 
PNEUMONIA  1  2/100 (2.00%) 
SALMONELLOSIS  1  1/100 (1.00%) 
SINUSITIS  1  1/100 (1.00%) 
STAPHYLOCOCCAL ABSCESS  1  1/100 (1.00%) 
SUBCUTANEOUS ABSCESS  1  2/100 (2.00%) 
TONSILLITIS  1  1/100 (1.00%) 
TOOTH ABSCESS  1  1/100 (1.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/100 (1.00%) 
VIRAL INFECTION  1  1/100 (1.00%) 
YERSINIA INFECTION  1  1/100 (1.00%) 
Injury, poisoning and procedural complications   
BONE CONTUSION  1  1/100 (1.00%) 
CONCUSSION  1  1/100 (1.00%) 
FACIAL BONES FRACTURE  1  1/100 (1.00%) 
RADIUS FRACTURE  1  1/100 (1.00%) 
ULNA FRACTURE  1  1/100 (1.00%) 
UPPER LIMB FRACTURE  1  1/100 (1.00%) 
Investigations   
HEART RATE IRREGULAR  1  1/100 (1.00%) 
Musculoskeletal and connective tissue disorders   
OSTEOARTHRITIS  1  1/100 (1.00%) 
SYSTEMIC LUPUS ERYTHEMATOSUS  1  1/100 (1.00%) 
Nervous system disorders   
DIZZINESS  1  1/100 (1.00%) 
SYNCOPE  1  1/100 (1.00%) 
Psychiatric disorders   
SCHIZOAFFECTIVE DISORDER  1  1/100 (1.00%) 
SOMATIC SYMPTOM DISORDER  1  1/100 (1.00%) 
SUICIDAL IDEATION  1  1/100 (1.00%) 
Reproductive system and breast disorders   
PELVIC FLUID COLLECTION  1  1/100 (1.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Any Adalimumab
Affected / at Risk (%)
Total   98/100 (98.00%) 
Blood and lymphatic system disorders   
ANAEMIA  1  8/100 (8.00%) 
LEUKOPENIA  1  5/100 (5.00%) 
LYMPHADENOPATHY  1  7/100 (7.00%) 
Cardiac disorders   
PALPITATIONS  1  5/100 (5.00%) 
Ear and labyrinth disorders   
EAR PAIN  1  5/100 (5.00%) 
Gastrointestinal disorders   
ABDOMINAL PAIN  1  24/100 (24.00%) 
ABDOMINAL PAIN UPPER  1  15/100 (15.00%) 
ANAL FISSURE  1  9/100 (9.00%) 
CONSTIPATION  1  15/100 (15.00%) 
CROHN'S DISEASE  1  24/100 (24.00%) 
DIARRHOEA  1  26/100 (26.00%) 
DYSPEPSIA  1  5/100 (5.00%) 
HAEMATOCHEZIA  1  8/100 (8.00%) 
MALPOSITIONED TEETH  1  6/100 (6.00%) 
NAUSEA  1  19/100 (19.00%) 
RECTAL HAEMORRHAGE  1  5/100 (5.00%) 
TOOTHACHE  1  5/100 (5.00%) 
VOMITING  1  22/100 (22.00%) 
General disorders   
FATIGUE  1  18/100 (18.00%) 
INJECTION SITE PAIN  1  7/100 (7.00%) 
INJECTION SITE REACTION  1  16/100 (16.00%) 
PAIN  1  6/100 (6.00%) 
PYREXIA  1  20/100 (20.00%) 
Immune system disorders   
HYPERSENSITIVITY  1  5/100 (5.00%) 
SEASONAL ALLERGY  1  8/100 (8.00%) 
Infections and infestations   
BRONCHITIS  1  11/100 (11.00%) 
CONJUNCTIVITIS  1  9/100 (9.00%) 
EAR INFECTION  1  10/100 (10.00%) 
EYE INFECTION  1  5/100 (5.00%) 
GASTROENTERITIS  1  7/100 (7.00%) 
GASTROENTERITIS VIRAL  1  7/100 (7.00%) 
HERPES ZOSTER  1  8/100 (8.00%) 
IMPETIGO  1  7/100 (7.00%) 
INFLUENZA  1  15/100 (15.00%) 
ORAL HERPES  1  5/100 (5.00%) 
OTITIS MEDIA  1  8/100 (8.00%) 
PHARYNGITIS  1  20/100 (20.00%) 
PHARYNGITIS STREPTOCOCCAL  1  14/100 (14.00%) 
PNEUMONIA  1  8/100 (8.00%) 
RESPIRATORY TRACT INFECTION VIRAL  1  5/100 (5.00%) 
RHINITIS  1  10/100 (10.00%) 
SINUSITIS  1  17/100 (17.00%) 
STAPHYLOCOCCAL INFECTION  1  5/100 (5.00%) 
TONSILLITIS  1  7/100 (7.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  31/100 (31.00%) 
URINARY TRACT INFECTION  1  14/100 (14.00%) 
VIRAL INFECTION  1  18/100 (18.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  39/100 (39.00%) 
Injury, poisoning and procedural complications   
CONTUSION  1  6/100 (6.00%) 
PROCEDURAL PAIN  1  9/100 (9.00%) 
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  1  6/100 (6.00%) 
ANTINUCLEAR ANTIBODY POSITIVE  1  5/100 (5.00%) 
C-REACTIVE PROTEIN INCREASED  1  15/100 (15.00%) 
RED BLOOD CELL SEDIMENTATION RATE INCREASED  1  8/100 (8.00%) 
Metabolism and nutrition disorders   
DECREASED APPETITE  1  6/100 (6.00%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  21/100 (21.00%) 
BACK PAIN  1  14/100 (14.00%) 
JOINT SWELLING  1  5/100 (5.00%) 
MUSCLE SPASMS  1  8/100 (8.00%) 
MYALGIA  1  9/100 (9.00%) 
PAIN IN EXTREMITY  1  9/100 (9.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
SKIN PAPILLOMA  1  13/100 (13.00%) 
Nervous system disorders   
DIZZINESS  1  6/100 (6.00%) 
HEADACHE  1  37/100 (37.00%) 
MIGRAINE  1  8/100 (8.00%) 
Psychiatric disorders   
DEPRESSION  1  6/100 (6.00%) 
INSOMNIA  1  6/100 (6.00%) 
Reproductive system and breast disorders   
DYSMENORRHOEA  1  7/100 (7.00%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  20/100 (20.00%) 
DYSPNOEA  1  5/100 (5.00%) 
EPISTAXIS  1  6/100 (6.00%) 
NASAL CONGESTION  1  12/100 (12.00%) 
OROPHARYNGEAL PAIN  1  27/100 (27.00%) 
RHINITIS ALLERGIC  1  5/100 (5.00%) 
RHINORRHOEA  1  7/100 (7.00%) 
SINUS CONGESTION  1  7/100 (7.00%) 
Skin and subcutaneous tissue disorders   
ACNE  1  7/100 (7.00%) 
ALOPECIA  1  5/100 (5.00%) 
DRY SKIN  1  7/100 (7.00%) 
ECZEMA  1  8/100 (8.00%) 
ERYTHEMA  1  6/100 (6.00%) 
PSORIASIS  1  5/100 (5.00%) 
RASH  1  15/100 (15.00%) 
URTICARIA  1  8/100 (8.00%) 
1
Term from vocabulary, MedDRA 20.0
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 (prior sponsor, Abbott)
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00686374    
Other Study ID Numbers: M06-807
2007-006494-90 ( EudraCT Number )
First Submitted: May 27, 2008
First Posted: May 29, 2008
Results First Submitted: March 20, 2018
Results First Posted: April 20, 2018
Last Update Posted: July 2, 2018