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

October 6, 2011 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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If the subject continues to demonstrate a lack of improvement on every week adalimumab therapy, they may be withdrawn from the study.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).

Study Type

Interventional

Enrollment (Actual)

945

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Site Ref # / Investigator 3077
      • Vienna, Austria, 1030
        • Site Ref # / Investigator 2978
      • Vienna, Austria, 1060
        • Site Ref # / Investigator 2975
      • Vienna, Austria, 1090
        • Site Ref # / Investigator 2976
      • Wels, Austria, A-4600
        • Site Ref # / Investigator 2977
  • Belgium
      • Bonheiden, Belgium, 2820
        • Site Ref # / Investigator 3023
      • Brussels, Belgium, 1090
        • Site Ref # / Investigator 3021
      • Brussels, Belgium, 1200
        • Site Ref # / Investigator 3074
      • Edegem, Belgium, 2650
        • Site Ref # / Investigator 3020
      • Ghent, Belgium, 9000
        • Site Ref # / Investigator 3625
      • Leuven, Belgium, 3000
        • Site Ref # / Investigator 3773
      • Liege, Belgium, 4000
        • Site Ref # / Investigator 3022
      • Roeselare, Belgium, 8800
        • Site Ref # / Investigator 3047
  • Czech Republic
      • Brno, Czech Republic, 62500
        • Site Ref # / Investigator 3893
      • Olomouc, Czech Republic, 77520
        • Site Ref # / Investigator 4657
      • Prague 5, Czech Republic, 15006
        • Site Ref # / Investigator 4660
      • Prague 7, Czech Republic, 17000
        • Site Ref # / Investigator 4659
  • Denmark
      • Aalborg, Denmark, 9000
        • Site Ref # / Investigator 3075
      • Aarhus C, Denmark, 8000
        • Site Ref # / Investigator 3037
      • Helsingor, Denmark, 3000
        • Site Ref # / Investigator 3088
      • Hvidovre, Denmark, 2650
        • Site Ref # / Investigator 3076
      • Odense C, Denmark, 5000
        • Site Ref # / Investigator 3019
  • Finland
      • Hyvinkaa, Finland, 05850
        • Site Ref # / Investigator 3623
  • France
      • Amiens, France, 80054
        • Site Ref # / Investigator 3032
      • Besancon, France, 25000
        • Site Ref # / Investigator 3012
      • Bethune, France, 62408
        • Site Ref # / Investigator 2983
      • Bordeaux, France, 33075
        • Site Ref # / Investigator 2993
      • Caen, France, 14033
        • Site Ref # / Investigator 2982
      • Clichy, France, 92110
        • Site Ref # / Investigator 3015
      • Colombes, France, 92701
        • Site Ref # / Investigator 3011
      • Creteil, France, 94010
        • Site Ref # / Investigator 3030
      • Creteil, France, 94010
        • Site Ref # / Investigator 3033
      • Evry, France, 91014
        • Site Ref # / Investigator 3027
      • Grenoble, France, 38043
        • Site Ref # / Investigator 3048
      • Lille Cedex, France, 59037
        • Site Ref # / Investigator 3097
      • Marseilles, France, 13015
        • Site Ref # / Investigator 3031
      • Montfermeil, France, 93370
        • Site Ref # / Investigator 2985
      • Montpellier, France, 34000
        • Site Ref # / Investigator 2994
      • Nantes, France, 44035
        • Site Ref # / Investigator 3014
      • Nice, France, 06202
        • Site Ref # / Investigator 3029
      • Paris, France, 75014
        • Site Ref # / Investigator 3017
      • Paris, France, 75018
        • Site Ref # / Investigator 2995
      • Paris, France, 75571
        • Site Ref # / Investigator 2996
      • Paris, France, 75679
        • Site Ref # / Investigator 3016
      • Paris, France, 75908
        • Site Ref # / Investigator 4275
      • Paris Cedex 10, France, 75475
        • Site Ref # / Investigator 3025
      • Pessac Cedex, France, 33600
        • Site Ref # / Investigator 3026
      • Pierre Benite, France, 69495
        • Site Ref # / Investigator 2974
      • Reims, France, 51092
        • Site Ref # / Investigator 3013
      • Rouen, France, 76031
        • Site Ref # / Investigator 3024
      • Strasbourg, France, 67089
        • Site Ref # / Investigator 2973
      • Toulouse, France, 31059
        • Site Ref # / Investigator 2986
      • Vandoeuvre Les Nancy, France, 54511
        • Site Ref # / Investigator 3018
  • Germany
      • Augsburg, Germany, D-86156
        • Site Ref # / Investigator 2969
      • Berlin, Germany, 10117
        • Site Ref # / Investigator 3096
      • Berlin, Germany, 10367
        • Site Ref # / Investigator 3041
      • Berlin, Germany, 12200
        • Site Ref # / Investigator 3070
      • Berlin, Germany, 13353
        • Site Ref # / Investigator 2980
      • Berlin, Germany, 14089
        • Site Ref # / Investigator 3089
      • Bochum, Germany, 44791
        • Site Ref # / Investigator 3084
      • Bochum, Germany, D-44789
        • Site Ref # / Investigator 3051
      • Braunschweig, Germany, 38126
        • Site Ref # / Investigator 3086
      • Cottbus, Germany, D-03048
        • Site Ref # / Investigator 3094
      • Dachau, Germany, 85221
        • Site Ref # / Investigator 2972
      • Dresden, Germany, 01067
        • Site Ref # / Investigator 3053
      • Dueren, Germany, 52351
        • Site Ref # / Investigator 3368
      • Erlangen, Germany, D-91054
        • Site Ref # / Investigator 3052
      • Essen, Germany, D-45239
        • Site Ref # / Investigator 3085
      • Frankfurt, Germany, 60318
        • Site Ref # / Investigator 3092
      • Freiburg, Germany, D-79106
        • Site Ref # / Investigator 3040
      • Halle, Germany, 06120
        • Site Ref # / Investigator 3066
      • Hamburg, Germany, 20148
        • Site Ref # / Investigator 2981
      • Hamburg, Germany, 20148
        • Site Ref # / Investigator 3044
      • Hamburg, Germany, 20246
        • Site Ref # / Investigator 2979
      • Hamburg, Germany, 22297
        • Site Ref # / Investigator 3043
      • Hamburg, Germany, 22559
        • Site Ref # / Investigator 3082
      • Hannover, Germany, 30625
        • Site Ref # / Investigator 3081
      • Heidelberg, Germany, 69120
        • Site Ref # / Investigator 3072
      • Herne, Germany, 44623
        • Site Ref # / Investigator 3093
      • Jena, Germany, 07747
        • Site Ref # / Investigator 3080
      • Karlsruhe, Germany, 76133
        • Site Ref # / Investigator 3034
      • Kiel, Germany, 24105
        • Site Ref # / Investigator 3617
      • Leipzig, Germany, 04103
        • Site Ref # / Investigator 3071
      • Luebeck, Germany, 23538
        • Site Ref # / Investigator 3091
      • Magdeburg, Germany, 39120
        • Site Ref # / Investigator 3090
      • Mainz, Germany, 55116
        • Site Ref # / Investigator 3049
      • Mainz, Germany, 55131
        • Site Ref # / Investigator 3083
      • Mannheim, Germany, 68161
        • Site Ref # / Investigator 3073
      • Minden, Germany, 32423
        • Site Ref # / Investigator 3050
      • Muenster, Germany, 48129
        • Site Ref # / Investigator 3056
      • Muenster, Germany, 48159
        • Site Ref # / Investigator 3057
      • Munich, Germany, 80639
        • Site Ref # / Investigator 3098
      • Munich, Germany, 81377
        • Site Ref # / Investigator 3055
      • Munich, Germany, 81925
        • Site Ref # / Investigator 3054
      • Osnabrueck, Germany, 49076
        • Site Ref # / Investigator 3046
      • Regensburg, Germany, 93053
        • Site Ref # / Investigator 3078
      • Rostock, Germany, 18057
        • Site Ref # / Investigator 3095
      • Rottenburg, Germany, 72108
        • Site Ref # / Investigator 2970
      • Stade, Germany, 21682
        • Site Ref # / Investigator 3042
      • Stuttgart, Germany, 70565
        • Site Ref # / Investigator 3045
      • Stuttgart, Germany, D-70376
        • Site Ref # / Investigator 3079
  • Greece
      • Athens, Greece, 106 76
        • Site Ref # / Investigator 4352
      • Athens, Greece, 106-76
        • Site Ref # / Investigator 4357
      • Athens, Greece, 124 62
        • Site Ref # / Investigator 4358
      • Heraklion, Greece, 71100
        • Site Ref # / Investigator 4606
      • Ioannina, Greece, 45500
        • Site Ref # / Investigator 4355
      • Nikaia, Greece, 184 54
        • Site Ref # / Investigator 4353
      • Thessaloniki, Greece, 54642
        • Site Ref # / Investigator 4359
      • Thessaloniki, Greece, 57010
        • Site Ref # / Investigator 4351
  • Ireland
      • Cork, Ireland
        • Site Ref # / Investigator 3326
      • Dublin 24, Ireland
        • Site Ref # / Investigator 3325
      • Dublin 9, Ireland
        • Site Ref # / Investigator 3324
  • Italy
      • Bologna, Italy, 40138
        • Site Ref # / Investigator 3953
      • Florence, Italy, 50134
        • Site Ref # / Investigator 3061
      • Milan, Italy, 20157
        • Site Ref # / Investigator 3035
      • Naples, Italy, 80131
        • Site Ref # / Investigator 3065
      • Padova, Italy, 35128
        • Site Ref # / Investigator 3036
      • Palermo, Italy, 90146
        • Site Ref # / Investigator 3062
      • Pavia, Italy, 27100
        • Site Ref # / Investigator 3063
      • Pescara, Italy, 65100
        • Site Ref # / Investigator 3058
      • Rome, Italy, 00133
        • Site Ref # / Investigator 3064
      • Rome, Italy, 00152
        • Site Ref # / Investigator 2991
      • Rome, Italy, 00186
        • Site Ref # / Investigator 3039
      • Rozzano, Italy, 20089
        • Site Ref # / Investigator 3087
      • San Donato Milanese, Italy, 20097
        • Site Ref # / Investigator 3038
  • Norway
      • Bergen, Norway, 5021
        • Site Ref # / Investigator 3618
      • Bodo, Norway, N-8092
        • Site Ref # / Investigator 3629
      • Hamar, Norway, N-2326
        • Site Ref # / Investigator 3630
      • Oslo, Norway, 0370
        • Site Ref # / Investigator 3620
      • Oslo, Norway, 0514
        • Site Ref # / Investigator 3619
  • Portugal
      • Braga, Portugal, 4700-308
        • Site Ref # / Investigator 3596
      • Coimbra, Portugal, 3000-075
        • Site Ref # / Investigator 3069
      • Lisbon, Portugal, 1150-069
        • Site Ref # / Investigator 4972
      • Lisbon, Portugal, 1649-035
        • Site Ref # / Investigator 3068
  • Slovakia
      • Bratislava, Slovakia, SK-813 69
        • Site Ref # / Investigator 3493
      • Kosice, Slovakia, 04001
        • Site Ref # / Investigator 4626
      • Presov, Slovakia, 08001
        • Site Ref # / Investigator 3494
  • Spain
      • Alicante, Spain, 03010
        • Site Ref # / Investigator 3448
      • Badalona - Barcelona, Spain, 08916
        • Site Ref # / Investigator 3009
      • Barakaldo, Spain, 48903
        • Site Ref # / Investigator 3005
      • Barcelona, Spain, 08003
        • Site Ref # / Investigator 2990
      • Barcelona, Spain, 08035
        • Site Ref # / Investigator 2989
      • Barcelona, Spain, 08036
        • Site Ref # / Investigator 3002
      • Barcelona, Spain, 08097
        • Site Ref # / Investigator 3486
      • Cabuenes-Gijon, Spain, 33203
        • Site Ref # / Investigator 2998
      • Galdakano, Spain, 48960
        • Site Ref # / Investigator 2988
      • Las Palmas de Gran Canaria, Spain, 35020
        • Site Ref # / Investigator 4383
      • Madrid, Spain, 28035
        • Site Ref # / Investigator 3484
      • Madrid, Spain, 28040
        • Site Ref # / Investigator 2997
      • Madrid, Spain, 28041
        • Site Ref # / Investigator 2999
      • Madrid, Spain, 28046
        • Site Ref # / Investigator 3447
      • Madrid, Spain, 28299
        • Site Ref # / Investigator 3595
      • Palma de Mallorca, Spain, 07014
        • Site Ref # / Investigator 3008
      • Santander, Spain, 39008
        • Site Ref # / Investigator 3000
      • Valencia, Spain, 46010
        • Site Ref # / Investigator 3003
      • Zaragoza, Spain, 50009
        • Site Ref # / Investigator 3007
      • Zaragoza, Spain, 50009
        • Site Ref # / Investigator 3010
  • Sweden
      • Gothenburg, Sweden, 41345
        • Site Ref # / Investigator 3895
      • Gothenburg, Sweden, 416 85
        • Site Ref # / Investigator 3500
      • Linkoping, Sweden, 581 85
        • Site Ref # / Investigator 3499
      • Lund, Sweden, 22185
        • Site Ref # / Investigator 3488
      • Oestersund, Sweden, 83183
        • Site Ref # / Investigator 3892
      • Skoevde, Sweden, 541 85
        • Site Ref # / Investigator 3498
      • Stockholm, Sweden, 114 86
        • Site Ref # / Investigator 3489
      • Stockholm, Sweden, 11883
        • Site Ref # / Investigator 3896
      • Stockholm, Sweden, 171 76
        • Site Ref # / Investigator 3487
      • Umea, Sweden, 901 85
        • Site Ref # / Investigator 3594
  • Switzerland
      • Basel, Switzerland, 4031
        • Site Ref # / Investigator 3323
      • Bern, Switzerland, 3010
        • Site Ref # / Investigator 3321
      • Lausanne, Switzerland, 1011
        • Site Ref # / Investigator 3322
      • Zurich, Switzerland, 8091
        • Site Ref # / Investigator 3794
  • United Kingdom
      • Barnstaple, United Kingdom, EX31 4JB
        • Site Ref # / Investigator 4604
      • Cardiff, United Kingdom, CF14 4XW
        • Site Ref # / Investigator 4590
      • Dundee, United Kingdom, DD1 9SY
        • Site Ref # / Investigator 4603
      • Edinburgh, United Kingdom, EH4 2XU
        • Site Ref # / Investigator 4579
      • Harrow, United Kingdom, HA1 3UJ
        • Site Ref # / Investigator 4588
      • Liverpool, United Kingdom, L7 8XP
        • Site Ref # / Investigator 4586
      • London, United Kingdom, NW1 2BU
        • Site Ref # / Investigator 4595
      • London, United Kingdom, SE1 7EH
        • Site Ref # / Investigator 4607
      • London, United Kingdom, SE5 9RS
        • Site Ref # / Investigator 4596
      • London, United Kingdom, W12 ONN
        • Site Ref # / Investigator 4580
      • Nottingham, United Kingdom, NG7 2UH
        • Site Ref # / Investigator 4591
      • Plymouth, United Kingdom, PL6 8DH
        • Site Ref # / Investigator 4589
      • Portsmouth, United Kingdom, PO6 3LY
        • Site Ref # / Investigator 4592
      • Rotherham, United Kingdom, S60 2UD
        • Site Ref # / Investigator 4597
      • Sheffield, United Kingdom, S10 2JF
        • Site Ref # / Investigator 4584
      • Southampton, United Kingdom, SO16 6YD
        • Site Ref # / Investigator 4578
      • Stockport, United Kingdom, SK2 7JE
        • Site Ref # / Investigator 4598
      • Surrey, United Kingdom, CR7 7YE
        • Site Ref # / Investigator 4581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label
Biological: adalimumab
Adalimumab 40 mg Every Other Week dosing
Other Names:
  • Humira
Biological: adalimumab
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.
Other Names:
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5.
Time Frame: Week 20 of treatment
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).
Week 20 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Week 20 of treatment
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).
Week 20 of treatment
Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20
Time Frame: Week 20 of treatment
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.
Week 20 of treatment
Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.
Time Frame: Week 20 of treatment
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.
Week 20 of treatment
Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20
Time Frame: Week 20 of treatment
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.
Week 20 of treatment
Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment
Time Frame: 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.
Week 20 of treatment
Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment
Time Frame: 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.
Week 20 of treatment
Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20
Time Frame: Week 20 of treatment
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).
Week 20 of treatment
Mean Change in Activity Impairment Score From Baseline to Week 20
Time Frame: Week 20 of treatment
Daily activity is one component of the Work Productivity and Activity Impairment Questionnaire. 0% = no impairment. A decrease in the mean indicates improvement.
Week 20 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Paul Pollack, MD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

December 8, 2006

First Submitted That Met QC Criteria

December 8, 2006

First Posted (Estimate)

December 11, 2006

Study Record Updates

Last Update Posted (Estimate)

October 10, 2011

Last Update Submitted That Met QC Criteria

October 6, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06-829
  • EudraCT:2006-002078-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Clinical Trials on adalimumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe