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A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With 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: NCT00445432
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : June 9, 2010
Last Update Posted : February 2, 2012
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
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
Interventions Biological: adalimumab
Other: Placebo
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow OL Adalimumab 40 mg Eow Any Adalimumab
Hide Arm/Group Description Double-blind adalimumab 40 mg every other week Double-blind adalimumab placebo every other week Open-label adalimumab 40 mg every other week All participants in NCT00445432 (Study M06-837) who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
Period Title: Through Week 52 of NCT00445432 (M06-837)
Started 25 25 32 0 [1]
Completed 10 2 21 0
Not Completed 15 23 11 0
Reason Not Completed
Adverse Event             1             2             7             0
Withdrawal by Subject             0             0             2             0
Moved to open-label             14             20             0             0
Other             0             1             2             0
[1]
This treatment group is not applicable for this period.
Period Title: 148 Weeks of Adalimumab Treatment
Started 0 [1] 0 [1] 0 [1] 79 [2]
Completed 0 0 0 35
Not Completed 0 0 0 44
Reason Not Completed
Adverse Event             0             0             0             32
Withdrawal by Subject             0             0             0             3
Other             0             0             0             9
[1]
This group is not applicable for this period.
[2]
3 participants discontinued while receiving double-blind placebo and never received any adalimumab
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow OL Adalimumab 40 mg Eow Total
Hide Arm/Group Description Double-blind adalimumab 40 mg every other week Double-blind adalimumab placebo every other week Open-label adalimumab 40 mg every other week Total of all reporting groups
Overall Number of Baseline Participants 25 25 32 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 32 participants 82 participants
<=18 years
0
   0.0%
2
   8.0%
3
   9.4%
5
   6.1%
Between 18 and 65 years
25
 100.0%
23
  92.0%
29
  90.6%
77
  93.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 32 participants 82 participants
31.60  (7.171) 30.80  (10.939) 30.75  (8.359) 31.02  (8.808)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 32 participants 82 participants
Female
9
  36.0%
10
  40.0%
14
  43.8%
33
  40.2%
Male
16
  64.0%
15
  60.0%
18
  56.3%
49
  59.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 25 participants 25 participants 32 participants 82 participants
25 25 32 82
1.Primary Outcome
Title Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment
Hide Description Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.
Time Frame Week 52 of double-blind treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow
Hide Arm/Group Description:
Double-blind adalimumab 40 mg every other week
Double-blind adalimumab placebo every other week
Overall Number of Participants Analyzed 21 22
Measure Type: Number
Unit of Measure: Participants
8 2
2.Secondary Outcome
Title Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment
Hide Description Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Time Frame Week 52 of double-blind treatment
Hide Outcome Measure Data
Hide Analysis Population Description
OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab [not placebo] during adalimumab induction study and who received >= 1 dose of DB study drug during this study). Nonresponder imputation (NRI) (CR-70 not achieved) used for DB treatments; LOCF for OL treatment.
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow OL Adalimumab 40 mg Eow
Hide Arm/Group Description:
Double-blind adalimumab 40 mg every other week
Double-blind adalimumab placebo every other week
Open-label adalimumab 40 mg every other week
Overall Number of Participants Analyzed 21 22 32
Measure Type: Number
Unit of Measure: Participants
9 2 10
3.Secondary Outcome
Title Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment
Hide Description Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Time Frame Week 52 of double-blind treatment
Hide Outcome Measure Data
Hide Analysis Population Description
OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab (not placebo) during adalimumab induction study and who received >= 1 dose of DB study drug during this study). NRI (CR-100 not achieved) used for missing data for DB treatments; LOCF for OL treatment.
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow OL Adalimumab 40 mg Eow
Hide Arm/Group Description:
Double-blind adalimumab 40 mg every other week
Double-blind adalimumab placebo every other week
Open-label adalimumab 40 mg every other week
Overall Number of Participants Analyzed 21 22 32
Measure Type: Number
Unit of Measure: Participants
8 2 8
4.Secondary Outcome
Title Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Hide Description Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Time Frame Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Hide Outcome Measure Data
Hide Analysis Population Description
modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow
Hide Arm/Group Description:
Double-blind adalimumab 40 mg every other week
Double-blind adalimumab placebo every other week
Overall Number of Participants Analyzed 21 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-83.7  (110.26) -9.1  (110.41)
5.Secondary Outcome
Title Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment
Hide Description Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Time Frame Week 52 of open-label treatment
Hide Outcome Measure Data
Hide Analysis Population Description
OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug). Last observation carried forward (LOCF) used for missing data.
Arm/Group Title OL Adalimumab 40 mg Eow
Hide Arm/Group Description:
Open-label adalimumab 40 mg every other week
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Participants
5
6.Secondary Outcome
Title Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Hide Description The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.
Time Frame Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow
Hide Arm/Group Description:
Double-blind adalimumab 40 mg every other week
Double-blind adalimumab placebo every other week
Overall Number of Participants Analyzed 21 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (1.89) -0.2  (1.34)
7.Secondary Outcome
Title Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Hide Description IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each item, participants select 1 of 7 responses. 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality (e.g., feeling of fatigue "none of the time"). Scoring range = 32 to 224. Higher scores indicate better quality of life; increases in IBDQ = improved overall quality of life.
Time Frame Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow
Hide Arm/Group Description:
Double-blind adalimumab 40 mg every other week
Double-blind adalimumab placebo every other week
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
27.8  (32.44) 1.8  (35.42)
8.Secondary Outcome
Title Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Hide Description The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 (Poorest Health) to 100 (Best Health).
Time Frame Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow
Hide Arm/Group Description:
Double-blind adalimumab 40 mg every other week
Double-blind adalimumab placebo every other week
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.4  (9.09) 0.2  (6.31)
9.Secondary Outcome
Title Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Hide Description The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).
Time Frame Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow
Hide Arm/Group Description:
Double-blind adalimumab 40 mg every other week
Double-blind adalimumab placebo every other week
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.6  (8.37) 0.3  (14.15)
10.Other Pre-specified Outcome
Title Number of Participants Who Had Clinical Remission at Week 148
Hide Description Clinical remission = Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.
Time Frame Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported as observed cases. No imputation technique was used.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
21
11.Other Pre-specified Outcome
Title Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148
Hide Description Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Time Frame Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported as observed cases. No imputation technique was used.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
28
12.Other Pre-specified Outcome
Title Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148
Hide Description Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Time Frame Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported as observed cases. No imputation technique was used.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
26
13.Other Pre-specified Outcome
Title Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 148
Hide Description Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/apthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >=0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Time Frame Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported as observed cases. No imputation technique was used.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
-143.0  (102.49)
14.Other Pre-specified Outcome
Title Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 148
Hide Description The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.
Time Frame Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported as observed cases. No imputation technique was used.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.7  (1.41)
15.Other Pre-specified Outcome
Title Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 148
Hide Description IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period with 32 questions about bowel function and related symptoms & their social/emotional impact. Per item, participants select 1 of 7 responses (1=poor quality of life [e.g., feeling of fatigue "all of the time"]; 7=good quality [e.g., feeling of fatigue "none of the time"]). Scoring range=32 to 224. Higher scores indicate better quality of life; increases in IBDQ=improved overall quality of life.
Time Frame Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported as observed cases. No imputation technique was used.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
27.2  (31.22)
16.Other Pre-specified Outcome
Title Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148
Hide Description The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 to 100, with 0=Poorest Health and 100=Best Health.
Time Frame Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported as observed cases. No imputation technique was used.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.44  (7.245)
17.Other Pre-specified Outcome
Title Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148
Hide Description The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).
Time Frame Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported as observed cases. No imputation technique was used.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.44  (11.173)
Time Frame 52 weeks for the double-blind (DB) treatments (adalimumab and placebo) and for the open-label adalimumab treatment. Overall study (maximum adalimumab treatment of 184 weeks plus 70-day follow-up period) for the Any Adalimumab group.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DB Adalimumab 40 mg Eow Placebo Eow OL Adalimumab 40 mg Eow Any Adalimumab
Hide Arm/Group Description Double-blind adalimumab 40 mg every other week Double-blind adalimumab placebo every other week Open-label adalimumab 40 mg every other week All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
All-Cause Mortality
DB Adalimumab 40 mg Eow Placebo Eow OL Adalimumab 40 mg Eow Any Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
DB Adalimumab 40 mg Eow Placebo Eow OL Adalimumab 40 mg Eow Any Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/25 (8.00%)   6/25 (24.00%)   13/32 (40.63%)   49/79 (62.03%) 
Blood and lymphatic system disorders         
Anaemia  1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Iron deficiency anaemia  1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Cardiac disorders         
Cardiac disorder * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Gastrointestinal disorders         
Crohn's disease * 1  1/25 (4.00%)  3/25 (12.00%)  9/32 (28.13%)  26/79 (32.91%) 
Intestinal obstruction * 1  1/25 (4.00%)  0/25 (0.00%)  1/32 (3.13%)  3/79 (3.80%) 
Intestinal perforation * 1  0/25 (0.00%)  1/25 (4.00%)  0/32 (0.00%)  2/79 (2.53%) 
Subileus * 1  0/25 (0.00%)  1/25 (4.00%)  0/32 (0.00%)  0/79 (0.00%) 
Duodenal stenosis * 1  0/25 (0.00%)  0/25 (0.00%)  1/32 (3.13%)  1/79 (1.27%) 
Intestinal stenosis * 1  0/25 (0.00%)  0/25 (0.00%)  1/32 (3.13%)  1/79 (1.27%) 
Anal fistula * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  2/79 (2.53%) 
Anal stenosis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Ileus * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Large intestinal stricture * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Nausea * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Peritonitis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  3/79 (3.80%) 
Small intestinal stenosis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  2/79 (2.53%) 
General disorders         
Malaise * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Pyrexia * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Systemic inflammatory response syndrome * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Hepatobiliary disorders         
Bile duct stone * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Cholangitis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Cholecystitis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Cholelithiasis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Infections and infestations         
Abdominal abscess * 1  1/25 (4.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Liver abscess * 1  0/25 (0.00%)  1/25 (4.00%)  0/32 (0.00%)  0/79 (0.00%) 
Perianal abscess * 1  0/25 (0.00%)  1/25 (4.00%)  0/32 (0.00%)  1/79 (1.27%) 
Enterocolitis viral * 1  0/25 (0.00%)  0/25 (0.00%)  1/32 (3.13%)  1/79 (1.27%) 
Bacteraemia * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Cellulitis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Gastroenteritis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Pneumonia * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Subdiaphragmatic abscess * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Injury, poisoning and procedural complications         
Anaemia postoperative  1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Investigations         
Blood phorphorus decreased  1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Metabolism and nutrition disorders         
Malnutrition * 1  0/25 (0.00%)  0/25 (0.00%)  1/32 (3.13%)  2/79 (2.53%) 
Nervous system disorders         
Somnolence * 1  0/25 (0.00%)  1/25 (4.00%)  0/32 (0.00%)  0/79 (0.00%) 
Depressed level of consciousness * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Dizziness * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Headache * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Hypoaesthesia * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Reproductive system and breast disorders         
Ovarian cyst * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Dyspnoea exertional * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Pharyngolaryngeal pain * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  1/79 (1.27%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DB Adalimumab 40 mg Eow Placebo Eow OL Adalimumab 40 mg Eow Any Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/25 (68.00%)   13/25 (52.00%)   28/32 (87.50%)   73/79 (92.41%) 
Blood and lymphatic system disorders         
Iron deficiency anaemia  1  0/25 (0.00%)  0/25 (0.00%)  6/32 (18.75%)  12/79 (15.19%) 
Eye disorders         
Ocular hyperaemia * 1  0/25 (0.00%)  0/25 (0.00%)  2/32 (6.25%)  4/79 (5.06%) 
Gastrointestinal disorders         
Crohn's disease * 1  2/25 (8.00%)  4/25 (16.00%)  4/32 (12.50%)  15/79 (18.99%) 
Dental caries * 1  3/25 (12.00%)  1/25 (4.00%)  3/32 (9.38%)  16/79 (20.25%) 
Dyspepsia * 1  0/25 (0.00%)  0/25 (0.00%)  2/32 (6.25%)  0/79 (0.00%) 
Periproctitis * 1  0/25 (0.00%)  0/25 (0.00%)  3/32 (9.38%)  0/79 (0.00%) 
Abdominal pain * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  8/79 (10.13%) 
Abdominal pain upper * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  6/79 (7.59%) 
Diarrhoea * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  6/79 (7.59%) 
Nausea * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  9/79 (11.39%) 
Stomatitis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Vomiting * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  5/79 (6.33%) 
General disorders         
Adverse drug reaction * 1  3/25 (12.00%)  1/25 (4.00%)  6/32 (18.75%)  22/79 (27.85%) 
Injection site reaction * 1  2/25 (8.00%)  0/25 (0.00%)  2/32 (6.25%)  6/79 (7.59%) 
Pain * 1  0/25 (0.00%)  2/25 (8.00%)  0/32 (0.00%)  0/79 (0.00%) 
Pyrexia * 1  2/25 (8.00%)  1/25 (4.00%)  3/32 (9.38%)  17/79 (21.52%) 
Oedema peripheral * 1  0/25 (0.00%)  0/25 (0.00%)  2/32 (6.25%)  0/79 (0.00%) 
Chest pain * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Malaise * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Hepatobiliary disorders         
Hepatic function abnormal  1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Infections and infestations         
Nasopharyngitis * 1  14/25 (56.00%)  3/25 (12.00%)  23/32 (71.88%)  60/79 (75.95%) 
Tinea pedis * 1  2/25 (8.00%)  0/25 (0.00%)  0/32 (0.00%)  0/79 (0.00%) 
Herpes simplex * 1  0/25 (0.00%)  0/25 (0.00%)  2/32 (6.25%)  7/79 (8.86%) 
Pharyngitis * 1  0/25 (0.00%)  0/25 (0.00%)  3/32 (9.38%)  5/79 (6.33%) 
Upper respiratory tract infection * 1  0/25 (0.00%)  0/25 (0.00%)  2/32 (6.25%)  6/79 (7.59%) 
Enteritis infectious * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Gastroenteritis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  7/79 (8.86%) 
Investigations         
Antinuclear antibody increased  1  2/25 (8.00%)  0/25 (0.00%)  0/32 (0.00%)  7/79 (8.86%) 
Blood creatine phosphokinase increased  1  1/25 (4.00%)  3/25 (12.00%)  3/32 (9.38%)  6/79 (7.59%) 
C-reactive protein increased  1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
DNA antibody positive  1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  5/79 (6.33%) 
Gamma-glutamyltransferase increased  1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  6/79 (7.59%) 
Lymphocyte morphology abnormal  1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  5/79 (6.33%) 
Weight decreased * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Metabolism and nutrition disorders         
Malnutrition * 1  0/25 (0.00%)  0/25 (0.00%)  2/32 (6.25%)  0/79 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  6/79 (7.59%) 
Back pain * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  6/79 (7.59%) 
Myalgia * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  5/79 (6.33%) 
Nervous system disorders         
Headache * 1  1/25 (4.00%)  2/25 (8.00%)  4/32 (12.50%)  16/79 (20.25%) 
Dizziness * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  5/79 (6.33%) 
Psychiatric disorders         
Insomnia * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  10/79 (12.66%) 
Respiratory, thoracic and mediastinal disorders         
Rhinorrhoea * 1  4/25 (16.00%)  0/25 (0.00%)  0/32 (0.00%)  8/79 (10.13%) 
Pharyngolaryngeal pain * 1  0/25 (0.00%)  0/25 (0.00%)  4/32 (12.50%)  11/79 (13.92%) 
Cough * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  6/79 (7.59%) 
Rhinitis allergic * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Skin and subcutaneous tissue disorders         
Acne * 1  0/25 (0.00%)  0/25 (0.00%)  2/32 (6.25%)  5/79 (6.33%) 
Rash * 1  0/25 (0.00%)  0/25 (0.00%)  3/32 (9.38%)  8/79 (10.13%) 
Eczema * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  6/79 (7.59%) 
Pruritus * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  8/79 (10.13%) 
Seborrhoeic dermatitis * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Urticaria * 1  0/25 (0.00%)  0/25 (0.00%)  0/32 (0.00%)  4/79 (5.06%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00445432    
Other Study ID Numbers: M06-837
First Submitted: March 7, 2007
First Posted: March 9, 2007
Results First Submitted: March 31, 2010
Results First Posted: June 9, 2010
Last Update Posted: February 2, 2012