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Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
adalimumab
adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of moderate to severe Crohn's Disease confirmed by endoscopy or radiologic evaluation for greater than 4 months (16 weeks)
  • Inadequate response to conventional therapy for Crohn's Disease
  • Subjects >=18 and <=75 years of age and in good health (Investigator discretion) with a recent stable medical history
  • Harvey Bradshaw Index score of 7 or higher

Exclusion Criteria:

  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
  • Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant
  • Previous treatment with adalimumab or previous participation in an adalimumab clinical study
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
  • Subjects with any prior exposure to Tysabri® (natalizumab)
  • Subjects on prednisone >40 mg/day (or equivalent), subjects on budesonide >9 mg/day, or subjects who are taking prednisone and budesonide concurrently at Baseline

Sites / Locations

  • Site Ref # / Investigator 3077
  • Site Ref # / Investigator 2978
  • Site Ref # / Investigator 2975
  • Site Ref # / Investigator 2976
  • Site Ref # / Investigator 2977
  • Site Ref # / Investigator 3023
  • Site Ref # / Investigator 3021
  • Site Ref # / Investigator 3074
  • Site Ref # / Investigator 3020
  • Site Ref # / Investigator 3625
  • Site Ref # / Investigator 3773
  • Site Ref # / Investigator 3022
  • Site Ref # / Investigator 3047
  • Site Ref # / Investigator 3893
  • Site Ref # / Investigator 4657
  • Site Ref # / Investigator 4660
  • Site Ref # / Investigator 4659
  • Site Ref # / Investigator 3075
  • Site Ref # / Investigator 3037
  • Site Ref # / Investigator 3088
  • Site Ref # / Investigator 3076
  • Site Ref # / Investigator 3019
  • Site Ref # / Investigator 3623
  • Site Ref # / Investigator 3032
  • Site Ref # / Investigator 3012
  • Site Ref # / Investigator 2983
  • Site Ref # / Investigator 2993
  • Site Ref # / Investigator 2982
  • Site Ref # / Investigator 3015
  • Site Ref # / Investigator 3011
  • Site Ref # / Investigator 3030
  • Site Ref # / Investigator 3033
  • Site Ref # / Investigator 3027
  • Site Ref # / Investigator 3048
  • Site Ref # / Investigator 3097
  • Site Ref # / Investigator 3031
  • Site Ref # / Investigator 2985
  • Site Ref # / Investigator 2994
  • Site Ref # / Investigator 3014
  • Site Ref # / Investigator 3029
  • Site Ref # / Investigator 3025
  • Site Ref # / Investigator 3017
  • Site Ref # / Investigator 2995
  • Site Ref # / Investigator 2996
  • Site Ref # / Investigator 3016
  • Site Ref # / Investigator 4275
  • Site Ref # / Investigator 3026
  • Site Ref # / Investigator 2974
  • Site Ref # / Investigator 3013
  • Site Ref # / Investigator 3024
  • Site Ref # / Investigator 2973
  • Site Ref # / Investigator 2986
  • Site Ref # / Investigator 3018
  • Site Ref # / Investigator 2969
  • Site Ref # / Investigator 3096
  • Site Ref # / Investigator 3041
  • Site Ref # / Investigator 3070
  • Site Ref # / Investigator 2980
  • Site Ref # / Investigator 3089
  • Site Ref # / Investigator 3084
  • Site Ref # / Investigator 3051
  • Site Ref # / Investigator 3086
  • Site Ref # / Investigator 3094
  • Site Ref # / Investigator 2972
  • Site Ref # / Investigator 3053
  • Site Ref # / Investigator 3368
  • Site Ref # / Investigator 3052
  • Site Ref # / Investigator 3085
  • Site Ref # / Investigator 3092
  • Site Ref # / Investigator 3040
  • Site Ref # / Investigator 3066
  • Site Ref # / Investigator 2981
  • Site Ref # / Investigator 3044
  • Site Ref # / Investigator 2979
  • Site Ref # / Investigator 3043
  • Site Ref # / Investigator 3082
  • Site Ref # / Investigator 3081
  • Site Ref # / Investigator 3072
  • Site Ref # / Investigator 3093
  • Site Ref # / Investigator 3080
  • Site Ref # / Investigator 3034
  • Site Ref # / Investigator 3617
  • Site Ref # / Investigator 3071
  • Site Ref # / Investigator 3091
  • Site Ref # / Investigator 3090
  • Site Ref # / Investigator 3049
  • Site Ref # / Investigator 3083
  • Site Ref # / Investigator 3073
  • Site Ref # / Investigator 3050
  • Site Ref # / Investigator 3056
  • Site Ref # / Investigator 3057
  • Site Ref # / Investigator 3098
  • Site Ref # / Investigator 3055
  • Site Ref # / Investigator 3054
  • Site Ref # / Investigator 3046
  • Site Ref # / Investigator 3078
  • Site Ref # / Investigator 3095
  • Site Ref # / Investigator 2970
  • Site Ref # / Investigator 3042
  • Site Ref # / Investigator 3045
  • Site Ref # / Investigator 3079
  • Site Ref # / Investigator 4352
  • Site Ref # / Investigator 4357
  • Site Ref # / Investigator 4358
  • Site Ref # / Investigator 4606
  • Site Ref # / Investigator 4355
  • Site Ref # / Investigator 4353
  • Site Ref # / Investigator 4359
  • Site Ref # / Investigator 4351
  • Site Ref # / Investigator 3326
  • Site Ref # / Investigator 3325
  • Site Ref # / Investigator 3324
  • Site Ref # / Investigator 3953
  • Site Ref # / Investigator 3061
  • Site Ref # / Investigator 3035
  • Site Ref # / Investigator 3065
  • Site Ref # / Investigator 3036
  • Site Ref # / Investigator 3062
  • Site Ref # / Investigator 3063
  • Site Ref # / Investigator 3058
  • Site Ref # / Investigator 3064
  • Site Ref # / Investigator 2991
  • Site Ref # / Investigator 3039
  • Site Ref # / Investigator 3087
  • Site Ref # / Investigator 3038
  • Site Ref # / Investigator 3618
  • Site Ref # / Investigator 3629
  • Site Ref # / Investigator 3630
  • Site Ref # / Investigator 3620
  • Site Ref # / Investigator 3619
  • Site Ref # / Investigator 3596
  • Site Ref # / Investigator 3069
  • Site Ref # / Investigator 4972
  • Site Ref # / Investigator 3068
  • Site Ref # / Investigator 3493
  • Site Ref # / Investigator 4626
  • Site Ref # / Investigator 3494
  • Site Ref # / Investigator 3448
  • Site Ref # / Investigator 3009
  • Site Ref # / Investigator 3005
  • Site Ref # / Investigator 2990
  • Site Ref # / Investigator 2989
  • Site Ref # / Investigator 3002
  • Site Ref # / Investigator 3486
  • Site Ref # / Investigator 2998
  • Site Ref # / Investigator 2988
  • Site Ref # / Investigator 4383
  • Site Ref # / Investigator 3484
  • Site Ref # / Investigator 2997
  • Site Ref # / Investigator 2999
  • Site Ref # / Investigator 3447
  • Site Ref # / Investigator 3595
  • Site Ref # / Investigator 3008
  • Site Ref # / Investigator 3000
  • Site Ref # / Investigator 3003
  • Site Ref # / Investigator 3007
  • Site Ref # / Investigator 3010
  • Site Ref # / Investigator 3895
  • Site Ref # / Investigator 3500
  • Site Ref # / Investigator 3499
  • Site Ref # / Investigator 3488
  • Site Ref # / Investigator 3892
  • Site Ref # / Investigator 3498
  • Site Ref # / Investigator 3489
  • Site Ref # / Investigator 3896
  • Site Ref # / Investigator 3487
  • Site Ref # / Investigator 3594
  • Site Ref # / Investigator 3323
  • Site Ref # / Investigator 3321
  • Site Ref # / Investigator 3322
  • Site Ref # / Investigator 3794
  • Site Ref # / Investigator 4604
  • Site Ref # / Investigator 4590
  • Site Ref # / Investigator 4603
  • Site Ref # / Investigator 4579
  • Site Ref # / Investigator 4588
  • Site Ref # / Investigator 4586
  • Site Ref # / Investigator 4595
  • Site Ref # / Investigator 4607
  • Site Ref # / Investigator 4596
  • Site Ref # / Investigator 4580
  • Site Ref # / Investigator 4591
  • Site Ref # / Investigator 4589
  • Site Ref # / Investigator 4592
  • Site Ref # / Investigator 4597
  • Site Ref # / Investigator 4584
  • Site Ref # / Investigator 4578
  • Site Ref # / Investigator 4598
  • Site Ref # / Investigator 4581

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5.
5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Maximum total score for HBI is not specified, is dependent on number of diarrhea times each day and number of complications. Clinical remission = HBI less than 5. Highest total score at Baseline was 47. Missing data were imputed using non-responder imputation (NRI).

Secondary Outcome Measures

Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.
5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Participants who had a decrease from Baseline of at least 3 points in HBI total score were considered responders. Missing data were imputed using non-responder imputation (NRI).
Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20
A count of the number of cutaneous fistulas draining was performed during each physical examination. Among participants who had draining fistulas at Baseline, the number of participants who had a reduction in the number of draining fistulas of at least 50% from Baseline to Week 20 of treatment was determined. Fistulas were classified as abdominal or perianal.
Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.
Number of participants who had EIM at baseline and had resolution of those manifestations at Week 20. EIM were skin lesions, eye lesions, joint complaints, CD-related hepatic disease, thrombosis, and nephrolithiasis. EIMs were determined by physical examination.
Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20
10-item assessment of health-related quality of life (QoL) in patients with inflammatory bowel disease. Participant marks an option from 1 to 7 for each item. For some items, 1=None of the time; for other items, 1=All of the time. Value for all items are summed. Total score=10 to 70; a high score=good quality of life (QoL). An increase in score indicates improvement. An absolute change in the SIBDQ score of 9 is considered a minimum clinically important difference (MCID) for a patient.
Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment
Percent Work Time Missed (Absenteeism) due to CD is one component of the Work Productivity and Activity Impairment (WPAI) Questionnaire. Score of 0% = no impairment. A decrease in the mean indicates improvement.
Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment
Percent impairment while working is a component of the Work Productivity and Activity Impairment measure. A score of 0% = no impairment. A decrease in mean score indicates lessening of impairment.
Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20
6-items that assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID).
Mean Change in Activity Impairment Score From Baseline to Week 20
Daily activity is one component of the Work Productivity and Activity Impairment Questionnaire. 0% = no impairment. A decrease in the mean indicates improvement.

Full Information

First Posted
December 8, 2006
Last Updated
October 6, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00409617
Brief Title
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
Official Title
A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient general well-being, health-related quality of life (QoL), fistula healing, CD-related extra-intestinal manifestations, work performance, and overall activity.
Detailed Description
This is an open-label, multi-center, study designed to evaluate the safety and efficacy of adalimumab on inducing and maintaining clinical remission in subjects with moderate to severe Crohn's Disease. Approximately 1000 subjects with a diagnosis of moderate to severe Crohn's Disease (Harvey Bradshaw Index score >= 7) will be enrolled at approximately 200 sites within Europe. Enrollment will be dependent on meeting all screening criteria. Study medication will be administered by subcutaneous injection. At Baseline (Week 0), all subjects will receive a dose of 160 mg adalimumab. At Week 2, all subjects will receive a dose of 80 mg adalimumab. Starting at Week 4, all subjects will begin receiving injections of adalimumab 40 mg every other week and will continue every other week dosing through Week 20 except in the case of disease flare or non-response. Starting at Week 12, subjects who experience a disease flare (flare is defined by an increase in the Harvey Bradshaw Index >=3 and a total Index score of >=7 when compared to Week 4) or are not responding to adalimumab treatment (non-response is defined as a decrease in the Harvey Bradshaw Index by fewer than 3 points compared to Baseline) will be permitted to increase study therapy to adalimumab 40 mg every week. If the subject continues to demonstrate a lack of improvement on every week adalimumab therapy, they may be withdrawn from the study. Prior to Week 8 subjects will not be allowed to increase or decrease Crohn's specific concomitant medications except in the event of concomitant Crohn's treatment-related toxicities assessed as moderate to severe. Changes in concomitant medications at/after Week 8 will be at the Investigator's discretion. Subjects will be evaluated for safety and efficacy at Baseline (Week 0), Weeks 2, 4, 8, 12, and 20, and at unscheduled visits. Efficacy evaluations include HBI, Short Inflammatory Bowel Disease Questionnaire (SIBDQ), Work Productivity Activity Index (WPAI) questionnaire, fistula counts, health care resource utilization (HCRU), and evaluation of CD-related extra-intestinal manifestations (EIMs). Safety assessments include vital signs, physical examination, general laboratory analyses, urinalysis, and monitoring of adverse events (AEs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
945 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
Humira
Intervention Description
Adalimumab 40 mg Every Other Week dosing
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
Humira
Intervention Description
Adalimumab 40 mg Every Week dosing if participant experiences a disease flare or is not responding to treatment. A disease flare is defined as an increase of 3 points or more on the HBI compared to the Baseline score and a total HBI score of 7 or higher. Non-response is defined as a decrease by fewer than 3 points in the HBI compared to Baseline.
Primary Outcome Measure Information:
Title
Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5.
Description
5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Maximum total score for HBI is not specified, is dependent on number of diarrhea times each day and number of complications. Clinical remission = HBI less than 5. Highest total score at Baseline was 47. Missing data were imputed using non-responder imputation (NRI).
Time Frame
Week 20 of treatment
Secondary Outcome Measure Information:
Title
Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.
Description
5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Participants who had a decrease from Baseline of at least 3 points in HBI total score were considered responders. Missing data were imputed using non-responder imputation (NRI).
Time Frame
Week 20 of treatment
Title
Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20
Description
A count of the number of cutaneous fistulas draining was performed during each physical examination. Among participants who had draining fistulas at Baseline, the number of participants who had a reduction in the number of draining fistulas of at least 50% from Baseline to Week 20 of treatment was determined. Fistulas were classified as abdominal or perianal.
Time Frame
Week 20 of treatment
Title
Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.
Description
Number of participants who had EIM at baseline and had resolution of those manifestations at Week 20. EIM were skin lesions, eye lesions, joint complaints, CD-related hepatic disease, thrombosis, and nephrolithiasis. EIMs were determined by physical examination.
Time Frame
Week 20 of treatment
Title
Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20
Description
10-item assessment of health-related quality of life (QoL) in patients with inflammatory bowel disease. Participant marks an option from 1 to 7 for each item. For some items, 1=None of the time; for other items, 1=All of the time. Value for all items are summed. Total score=10 to 70; a high score=good quality of life (QoL). An increase in score indicates improvement. An absolute change in the SIBDQ score of 9 is considered a minimum clinically important difference (MCID) for a patient.
Time Frame
Week 20 of treatment
Title
Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment
Description
Percent Work Time Missed (Absenteeism) due to CD is one component of the Work Productivity and Activity Impairment (WPAI) Questionnaire. Score of 0% = no impairment. A decrease in the mean indicates improvement.
Time Frame
Week 20 of treatment
Title
Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment
Description
Percent impairment while working is a component of the Work Productivity and Activity Impairment measure. A score of 0% = no impairment. A decrease in mean score indicates lessening of impairment.
Time Frame
Week 20 of treatment
Title
Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20
Description
6-items that assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID).
Time Frame
Week 20 of treatment
Title
Mean Change in Activity Impairment Score From Baseline to Week 20
Description
Daily activity is one component of the Work Productivity and Activity Impairment Questionnaire. 0% = no impairment. A decrease in the mean indicates improvement.
Time Frame
Week 20 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of moderate to severe Crohn's Disease confirmed by endoscopy or radiologic evaluation for greater than 4 months (16 weeks) Inadequate response to conventional therapy for Crohn's Disease Subjects >=18 and <=75 years of age and in good health (Investigator discretion) with a recent stable medical history Harvey Bradshaw Index score of 7 or higher Exclusion Criteria: Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study Female subject who is pregnant or breast-feeding or considering becoming pregnant Previous treatment with adalimumab or previous participation in an adalimumab clinical study Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study Subjects with any prior exposure to Tysabri® (natalizumab) Subjects on prednisone >40 mg/day (or equivalent), subjects on budesonide >9 mg/day, or subjects who are taking prednisone and budesonide concurrently at Baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Pollack, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Ref # / Investigator 3077
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Site Ref # / Investigator 2978
City
Vienna
ZIP/Postal Code
1030
Country
Austria
Facility Name
Site Ref # / Investigator 2975
City
Vienna
ZIP/Postal Code
1060
Country
Austria
Facility Name
Site Ref # / Investigator 2976
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Site Ref # / Investigator 2977
City
Wels
ZIP/Postal Code
A-4600
Country
Austria
Facility Name
Site Ref # / Investigator 3023
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Site Ref # / Investigator 3021
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Site Ref # / Investigator 3074
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Site Ref # / Investigator 3020
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Site Ref # / Investigator 3625
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site Ref # / Investigator 3773
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site Ref # / Investigator 3022
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Site Ref # / Investigator 3047
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Site Ref # / Investigator 3893
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Site Ref # / Investigator 4657
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Site Ref # / Investigator 4660
City
Prague 5
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Site Ref # / Investigator 4659
City
Prague 7
ZIP/Postal Code
17000
Country
Czech Republic
Facility Name
Site Ref # / Investigator 3075
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Site Ref # / Investigator 3037
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Site Ref # / Investigator 3088
City
Helsingor
ZIP/Postal Code
3000
Country
Denmark
Facility Name
Site Ref # / Investigator 3076
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Site Ref # / Investigator 3019
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Site Ref # / Investigator 3623
City
Hyvinkaa
ZIP/Postal Code
05850
Country
Finland
Facility Name
Site Ref # / Investigator 3032
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Site Ref # / Investigator 3012
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Site Ref # / Investigator 2983
City
Bethune
ZIP/Postal Code
62408
Country
France
Facility Name
Site Ref # / Investigator 2993
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Site Ref # / Investigator 2982
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Site Ref # / Investigator 3015
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Site Ref # / Investigator 3011
City
Colombes
ZIP/Postal Code
92701
Country
France
Facility Name
Site Ref # / Investigator 3030
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Site Ref # / Investigator 3033
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Site Ref # / Investigator 3027
City
Evry
ZIP/Postal Code
91014
Country
France
Facility Name
Site Ref # / Investigator 3048
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Site Ref # / Investigator 3097
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Site Ref # / Investigator 3031
City
Marseilles
ZIP/Postal Code
13015
Country
France
Facility Name
Site Ref # / Investigator 2985
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Site Ref # / Investigator 2994
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Site Ref # / Investigator 3014
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Site Ref # / Investigator 3029
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Site Ref # / Investigator 3025
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Site Ref # / Investigator 3017
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Site Ref # / Investigator 2995
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Site Ref # / Investigator 2996
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Site Ref # / Investigator 3016
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Site Ref # / Investigator 4275
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Site Ref # / Investigator 3026
City
Pessac Cedex
ZIP/Postal Code
33600
Country
France
Facility Name
Site Ref # / Investigator 2974
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Site Ref # / Investigator 3013
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Site Ref # / Investigator 3024
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Site Ref # / Investigator 2973
City
Strasbourg
ZIP/Postal Code
67089
Country
France
Facility Name
Site Ref # / Investigator 2986
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Site Ref # / Investigator 3018
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Site Ref # / Investigator 2969
City
Augsburg
ZIP/Postal Code
D-86156
Country
Germany
Facility Name
Site Ref # / Investigator 3096
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Site Ref # / Investigator 3041
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Site Ref # / Investigator 3070
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Site Ref # / Investigator 2980
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Site Ref # / Investigator 3089
City
Berlin
ZIP/Postal Code
14089
Country
Germany
Facility Name
Site Ref # / Investigator 3084
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Site Ref # / Investigator 3051
City
Bochum
ZIP/Postal Code
D-44789
Country
Germany
Facility Name
Site Ref # / Investigator 3086
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Site Ref # / Investigator 3094
City
Cottbus
ZIP/Postal Code
D-03048
Country
Germany
Facility Name
Site Ref # / Investigator 2972
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
Site Ref # / Investigator 3053
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Site Ref # / Investigator 3368
City
Dueren
ZIP/Postal Code
52351
Country
Germany
Facility Name
Site Ref # / Investigator 3052
City
Erlangen
ZIP/Postal Code
D-91054
Country
Germany
Facility Name
Site Ref # / Investigator 3085
City
Essen
ZIP/Postal Code
D-45239
Country
Germany
Facility Name
Site Ref # / Investigator 3092
City
Frankfurt
ZIP/Postal Code
60318
Country
Germany
Facility Name
Site Ref # / Investigator 3040
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Site Ref # / Investigator 3066
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Site Ref # / Investigator 2981
City
Hamburg
ZIP/Postal Code
20148
Country
Germany
Facility Name
Site Ref # / Investigator 3044
City
Hamburg
ZIP/Postal Code
20148
Country
Germany
Facility Name
Site Ref # / Investigator 2979
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Site Ref # / Investigator 3043
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
Site Ref # / Investigator 3082
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Site Ref # / Investigator 3081
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Site Ref # / Investigator 3072
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Site Ref # / Investigator 3093
City
Herne
ZIP/Postal Code
44623
Country
Germany
Facility Name
Site Ref # / Investigator 3080
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Site Ref # / Investigator 3034
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Site Ref # / Investigator 3617
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Site Ref # / Investigator 3071
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Site Ref # / Investigator 3091
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Site Ref # / Investigator 3090
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Site Ref # / Investigator 3049
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Site Ref # / Investigator 3083
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Site Ref # / Investigator 3073
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Site Ref # / Investigator 3050
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Site Ref # / Investigator 3056
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Site Ref # / Investigator 3057
City
Muenster
ZIP/Postal Code
48159
Country
Germany
Facility Name
Site Ref # / Investigator 3098
City
Munich
ZIP/Postal Code
80639
Country
Germany
Facility Name
Site Ref # / Investigator 3055
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Site Ref # / Investigator 3054
City
Munich
ZIP/Postal Code
81925
Country
Germany
Facility Name
Site Ref # / Investigator 3046
City
Osnabrueck
ZIP/Postal Code
49076
Country
Germany
Facility Name
Site Ref # / Investigator 3078
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Site Ref # / Investigator 3095
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Site Ref # / Investigator 2970
City
Rottenburg
ZIP/Postal Code
72108
Country
Germany
Facility Name
Site Ref # / Investigator 3042
City
Stade
ZIP/Postal Code
21682
Country
Germany
Facility Name
Site Ref # / Investigator 3045
City
Stuttgart
ZIP/Postal Code
70565
Country
Germany
Facility Name
Site Ref # / Investigator 3079
City
Stuttgart
ZIP/Postal Code
D-70376
Country
Germany
Facility Name
Site Ref # / Investigator 4352
City
Athens
ZIP/Postal Code
106 76
Country
Greece
Facility Name
Site Ref # / Investigator 4357
City
Athens
ZIP/Postal Code
106-76
Country
Greece
Facility Name
Site Ref # / Investigator 4358
City
Athens
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Site Ref # / Investigator 4606
City
Heraklion
ZIP/Postal Code
71100
Country
Greece
Facility Name
Site Ref # / Investigator 4355
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Site Ref # / Investigator 4353
City
Nikaia
ZIP/Postal Code
184 54
Country
Greece
Facility Name
Site Ref # / Investigator 4359
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Site Ref # / Investigator 4351
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Site Ref # / Investigator 3326
City
Cork
Country
Ireland
Facility Name
Site Ref # / Investigator 3325
City
Dublin 24
Country
Ireland
Facility Name
Site Ref # / Investigator 3324
City
Dublin 9
Country
Ireland
Facility Name
Site Ref # / Investigator 3953
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Site Ref # / Investigator 3061
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Site Ref # / Investigator 3035
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Site Ref # / Investigator 3065
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Site Ref # / Investigator 3036
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Site Ref # / Investigator 3062
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Site Ref # / Investigator 3063
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Site Ref # / Investigator 3058
City
Pescara
ZIP/Postal Code
65100
Country
Italy
Facility Name
Site Ref # / Investigator 3064
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Site Ref # / Investigator 2991
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Site Ref # / Investigator 3039
City
Rome
ZIP/Postal Code
00186
Country
Italy
Facility Name
Site Ref # / Investigator 3087
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Site Ref # / Investigator 3038
City
San Donato Milanese
ZIP/Postal Code
20097
Country
Italy
Facility Name
Site Ref # / Investigator 3618
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Site Ref # / Investigator 3629
City
Bodo
ZIP/Postal Code
N-8092
Country
Norway
Facility Name
Site Ref # / Investigator 3630
City
Hamar
ZIP/Postal Code
N-2326
Country
Norway
Facility Name
Site Ref # / Investigator 3620
City
Oslo
ZIP/Postal Code
0370
Country
Norway
Facility Name
Site Ref # / Investigator 3619
City
Oslo
ZIP/Postal Code
0514
Country
Norway
Facility Name
Site Ref # / Investigator 3596
City
Braga
ZIP/Postal Code
4700-308
Country
Portugal
Facility Name
Site Ref # / Investigator 3069
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Site Ref # / Investigator 4972
City
Lisbon
ZIP/Postal Code
1150-069
Country
Portugal
Facility Name
Site Ref # / Investigator 3068
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Site Ref # / Investigator 3493
City
Bratislava
ZIP/Postal Code
SK-813 69
Country
Slovakia
Facility Name
Site Ref # / Investigator 4626
City
Kosice
ZIP/Postal Code
04001
Country
Slovakia
Facility Name
Site Ref # / Investigator 3494
City
Presov
ZIP/Postal Code
08001
Country
Slovakia
Facility Name
Site Ref # / Investigator 3448
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Site Ref # / Investigator 3009
City
Badalona - Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Site Ref # / Investigator 3005
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Site Ref # / Investigator 2990
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Site Ref # / Investigator 2989
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Site Ref # / Investigator 3002
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Site Ref # / Investigator 3486
City
Barcelona
ZIP/Postal Code
08097
Country
Spain
Facility Name
Site Ref # / Investigator 2998
City
Cabuenes-Gijon
ZIP/Postal Code
33203
Country
Spain
Facility Name
Site Ref # / Investigator 2988
City
Galdakano
ZIP/Postal Code
48960
Country
Spain
Facility Name
Site Ref # / Investigator 4383
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35020
Country
Spain
Facility Name
Site Ref # / Investigator 3484
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Site Ref # / Investigator 2997
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Site Ref # / Investigator 2999
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Site Ref # / Investigator 3447
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Site Ref # / Investigator 3595
City
Madrid
ZIP/Postal Code
28299
Country
Spain
Facility Name
Site Ref # / Investigator 3008
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Site Ref # / Investigator 3000
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Site Ref # / Investigator 3003
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Site Ref # / Investigator 3007
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Site Ref # / Investigator 3010
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Site Ref # / Investigator 3895
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Site Ref # / Investigator 3500
City
Gothenburg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Site Ref # / Investigator 3499
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Site Ref # / Investigator 3488
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Site Ref # / Investigator 3892
City
Oestersund
ZIP/Postal Code
83183
Country
Sweden
Facility Name
Site Ref # / Investigator 3498
City
Skoevde
ZIP/Postal Code
541 85
Country
Sweden
Facility Name
Site Ref # / Investigator 3489
City
Stockholm
ZIP/Postal Code
114 86
Country
Sweden
Facility Name
Site Ref # / Investigator 3896
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Site Ref # / Investigator 3487
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Site Ref # / Investigator 3594
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Site Ref # / Investigator 3323
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Site Ref # / Investigator 3321
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Site Ref # / Investigator 3322
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Site Ref # / Investigator 3794
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Site Ref # / Investigator 4604
City
Barnstaple
ZIP/Postal Code
EX31 4JB
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4590
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4603
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4579
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4588
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4586
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4595
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4607
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4596
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4580
City
London
ZIP/Postal Code
W12 ONN
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4591
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4589
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4592
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4597
City
Rotherham
ZIP/Postal Code
S60 2UD
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4584
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4578
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4598
City
Stockport
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
Facility Name
Site Ref # / Investigator 4581
City
Surrey
ZIP/Postal Code
CR7 7YE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22480772
Citation
Louis E, Lofberg R, Reinisch W, Camez A, Yang M, Pollack PF, Chen N, Chao J, Mulani PM. Adalimumab improves patient-reported outcomes and reduces indirect costs in patients with moderate to severe Crohn's disease: results from the CARE trial. J Crohns Colitis. 2013 Feb;7(1):34-43. doi: 10.1016/j.crohns.2012.02.017. Epub 2012 Apr 4.
Results Reference
derived

Learn more about this trial

Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

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