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

NCT00409617 | Completed Phase 3 Results

• 2 other identifiers: M06-829EudraCT:2006-002078-23
• Study Type: interventional
• Target: 945
• Locations: 17 countries
• Sites: 189

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  Week 20 of treatment

Secondary Outcomes (8)

• 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.

  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

  Week 20 of treatment

• Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.

  Week 20 of treatment

• Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20

  Week 20 of treatment

• Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment

  Week 20 of treatment

Study Arms (1)

Open Label

EXPERIMENTAL

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

Adalimumab 40 mg Every Other Week dosing

Also known as: Humira

Open Label

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (189)

Site Ref # / Investigator 3077

Graz, 8036, Austria

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Site Ref # / Investigator 2978

Vienna, 1030, Austria

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Site Ref # / Investigator 2975

Vienna, 1060, Austria

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Site Ref # / Investigator 2976

Vienna, 1090, Austria

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Site Ref # / Investigator 2977

Wels, A-4600, Austria

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Site Ref # / Investigator 3023

Bonheiden, 2820, Belgium

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Site Ref # / Investigator 3021

Brussels, 1090, Belgium

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Site Ref # / Investigator 3074

Brussels, 1200, Belgium

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Site Ref # / Investigator 3020

Edegem, 2650, Belgium

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Site Ref # / Investigator 3625

Ghent, 9000, Belgium

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Site Ref # / Investigator 3773

Leuven, 3000, Belgium

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Site Ref # / Investigator 3022

Liège, 4000, Belgium

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Site Ref # / Investigator 3047

Roeselare, 8800, Belgium

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Site Ref # / Investigator 3893

Brno, 62500, Czechia

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Site Ref # / Investigator 4657

Olomouc, 77520, Czechia

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Site Ref # / Investigator 4660

Prague, 15006, Czechia

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Site Ref # / Investigator 4659

Prague, 17000, Czechia

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Site Ref # / Investigator 3075

Aalborg, 9000, Denmark

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Site Ref # / Investigator 3037

Aarhus C, 8000, Denmark

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Site Ref # / Investigator 3088

Elsinore, 3000, Denmark

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Site Ref # / Investigator 3076

Hvidovre, 2650, Denmark

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Site Ref # / Investigator 3019

Odense C, 5000, Denmark

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Site Ref # / Investigator 3623

Hyvinkää, 05850, Finland

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Site Ref # / Investigator 3032

Amiens, 80054, France

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Site Ref # / Investigator 3012

Besançon, 25000, France

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Site Ref # / Investigator 2983

Béthune, 62408, France

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Site Ref # / Investigator 2993

Bordeaux, 33075, France

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Site Ref # / Investigator 2982

Caen, 14033, France

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Site Ref # / Investigator 3015

Clichy, 92110, France

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Site Ref # / Investigator 3011

Colombes, 92701, France

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Site Ref # / Investigator 3030

Créteil, 94010, France

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Site Ref # / Investigator 3033

Créteil, 94010, France

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Site Ref # / Investigator 3027

Évry, 91014, France

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Site Ref # / Investigator 3048

Grenoble, 38043, France

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Site Ref # / Investigator 3097

Lille, 59037, France

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Site Ref # / Investigator 3031

Marseille, 13015, France

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Site Ref # / Investigator 2985

Montfermeil, 93370, France

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Site Ref # / Investigator 2994

Montpellier, 34000, France

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Site Ref # / Investigator 3014

Nantes, 44035, France

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Site Ref # / Investigator 3029

Nice, 06202, France

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Site Ref # / Investigator 3017

Paris, 75014, France

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Site Ref # / Investigator 2995

Paris, 75018, France

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Site Ref # / Investigator 3025

Paris, 75475, France

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Site Ref # / Investigator 2996

Paris, 75571, France

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Site Ref # / Investigator 3016

Paris, 75679, France

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Site Ref # / Investigator 4275

Paris, 75908, France

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Site Ref # / Investigator 3026

Pessac, 33600, France

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Site Ref # / Investigator 2974

Pierre-Bénite, 69495, France

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Site Ref # / Investigator 3013

Reims, 51092, France

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Site Ref # / Investigator 3024

Rouen, 76031, France

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Site Ref # / Investigator 2973

Strasbourg, 67089, France

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Site Ref # / Investigator 2986

Toulouse, 31059, France

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Site Ref # / Investigator 3018

Vandœuvre-lès-Nancy, 54511, France

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Site Ref # / Investigator 2969

Augsburg, D-86156, Germany

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Site Ref # / Investigator 3096

Berlin, 10117, Germany

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Site Ref # / Investigator 3041

Berlin, 10367, Germany

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Site Ref # / Investigator 3070

Berlin, 12200, Germany

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Site Ref # / Investigator 2980

Berlin, 13353, Germany

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Site Ref # / Investigator 3089

Berlin, 14089, Germany

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Site Ref # / Investigator 3084

Bochum, 44791, Germany

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Site Ref # / Investigator 3051

Bochum, D-44789, Germany

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Site Ref # / Investigator 3086

Braunschweig, 38126, Germany

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Site Ref # / Investigator 3094

Cottbus, D-03048, Germany

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Site Ref # / Investigator 2972

Dachau, 85221, Germany

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Site Ref # / Investigator 3053

Dresden, 01067, Germany

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Site Ref # / Investigator 3368

Düren, 52351, Germany

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Site Ref # / Investigator 3052

Erlangen, D-91054, Germany

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Site Ref # / Investigator 3085

Essen, D-45239, Germany

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Site Ref # / Investigator 3092

Frankfurt, 60318, Germany

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Site Ref # / Investigator 3040

Freiburg im Breisgau, D-79106, Germany

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Site Ref # / Investigator 3066

Halle, 06120, Germany

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Site Ref # / Investigator 2981

Hamburg, 20148, Germany

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Site Ref # / Investigator 3044

Hamburg, 20148, Germany

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Site Ref # / Investigator 2979

Hamburg, 20246, Germany

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Site Ref # / Investigator 3043

Hamburg, 22297, Germany

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Site Ref # / Investigator 3082

Hamburg, 22559, Germany

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Site Ref # / Investigator 3081

Hanover, 30625, Germany

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Site Ref # / Investigator 3072

Heidelberg, 69120, Germany

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Site Ref # / Investigator 3093

Herne, 44623, Germany

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Site Ref # / Investigator 3080

Jena, 07747, Germany

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Site Ref # / Investigator 3034

Karlsruhe, 76133, Germany

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Site Ref # / Investigator 3617

Kiel, 24105, Germany

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Site Ref # / Investigator 3071

Leipzig, 04103, Germany

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Site Ref # / Investigator 3091

Lübeck, 23538, Germany

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Site Ref # / Investigator 3090

Magdeburg, 39120, Germany

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Site Ref # / Investigator 3049

Mainz, 55116, Germany

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Site Ref # / Investigator 3083

Mainz, 55131, Germany

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Site Ref # / Investigator 3073

Mannheim, 68161, Germany

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Site Ref # / Investigator 3050

Minden, 32423, Germany

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Site Ref # / Investigator 3098

Munich, 80639, Germany

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Site Ref # / Investigator 3055

Munich, 81377, Germany

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Site Ref # / Investigator 3054

Munich, 81925, Germany

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Site Ref # / Investigator 3056

Münster, 48129, Germany

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Site Ref # / Investigator 3057

Münster, 48159, Germany

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Site Ref # / Investigator 3046

Osnabrück, 49076, Germany

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Site Ref # / Investigator 3078

Regensburg, 93053, Germany

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Site Ref # / Investigator 3095

Rostock, 18057, Germany

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Site Ref # / Investigator 2970

Rottenburg, 72108, Germany

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Site Ref # / Investigator 3042

Stade, 21682, Germany

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Site Ref # / Investigator 3045

Stuttgart, 70565, Germany

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Site Ref # / Investigator 3079

Stuttgart, D-70376, Germany

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Site Ref # / Investigator 4352

Athens, 106 76, Greece

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Site Ref # / Investigator 4357

Athens, 106-76, Greece

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Site Ref # / Investigator 4358

Athens, 124 62, Greece

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Site Ref # / Investigator 4606

Heraklion, 71100, Greece

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Site Ref # / Investigator 4355

Ioannina, 45500, Greece

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Site Ref # / Investigator 4353

Nikaia, 184 54, Greece

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Site Ref # / Investigator 4359

Thessaloniki, 54642, Greece

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Site Ref # / Investigator 4351

Thessaloniki, 57010, Greece

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Site Ref # / Investigator 3326

Cork, Ireland

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Site Ref # / Investigator 3324

Dublin, Ireland

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Site Ref # / Investigator 3325

Dublin, Ireland

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Site Ref # / Investigator 3953

Bologna, 40138, Italy

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Site Ref # / Investigator 3061

Florence, 50134, Italy

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Site Ref # / Investigator 3035

Milan, 20157, Italy

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Site Ref # / Investigator 3065

Naples, 80131, Italy

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Site Ref # / Investigator 3036

Padua, 35128, Italy

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Site Ref # / Investigator 3062

Palermo, 90146, Italy

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Site Ref # / Investigator 3063

Pavia, 27100, Italy

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Site Ref # / Investigator 3058

Pescara, 65100, Italy

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Site Ref # / Investigator 3064

Rome, 00133, Italy

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Site Ref # / Investigator 2991

Rome, 00152, Italy

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Site Ref # / Investigator 3039

Rome, 00186, Italy

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Site Ref # / Investigator 3087

Rozzano, 20089, Italy

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Site Ref # / Investigator 3038

San Donato Milanese, 20097, Italy

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Site Ref # / Investigator 3618

Bergen, 5021, Norway

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Site Ref # / Investigator 3629

Bodø, N-8092, Norway

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Site Ref # / Investigator 3630

Hamar, N-2326, Norway

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Site Ref # / Investigator 3620

Oslo, 0370, Norway

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Site Ref # / Investigator 3619

Oslo, 0514, Norway

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Site Ref # / Investigator 3596

Braga, 4700-308, Portugal

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Site Ref # / Investigator 3069

Coimbra, 3000-075, Portugal

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Site Ref # / Investigator 4972

Lisbon, 1150-069, Portugal

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Site Ref # / Investigator 3068

Lisbon, 1649-035, Portugal

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Site Ref # / Investigator 3493

Bratislava, SK-813 69, Slovakia

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Site Ref # / Investigator 4626

Košice, 04001, Slovakia

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Site Ref # / Investigator 3494

Prešov, 08001, Slovakia

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Site Ref # / Investigator 3448

Alicante, 03010, Spain

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Site Ref # / Investigator 3009

Badalona - Barcelona, 08916, Spain

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Site Ref # / Investigator 3005

Barakaldo, 48903, Spain

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Site Ref # / Investigator 2990

Barcelona, 08003, Spain

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Site Ref # / Investigator 2989

Barcelona, 08035, Spain

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Site Ref # / Investigator 3002

Barcelona, 08036, Spain

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Site Ref # / Investigator 3486

Barcelona, 08097, Spain

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Site Ref # / Investigator 2998

Cabuenes-Gijon, 33203, Spain

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Site Ref # / Investigator 2988

Galdakano, 48960, Spain

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Site Ref # / Investigator 4383

Las Palmas de Gran Canaria, 35020, Spain

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Site Ref # / Investigator 3484

Madrid, 28035, Spain

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Site Ref # / Investigator 2997

Madrid, 28040, Spain

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Site Ref # / Investigator 2999

Madrid, 28041, Spain

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Site Ref # / Investigator 3447

Madrid, 28046, Spain

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Site Ref # / Investigator 3595

Madrid, 28299, Spain

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Site Ref # / Investigator 3008

Palma de Mallorca, 07014, Spain

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Site Ref # / Investigator 3000

Santander, 39008, Spain

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Site Ref # / Investigator 3003

Valencia, 46010, Spain

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Site Ref # / Investigator 3007

Zaragoza, 50009, Spain

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Site Ref # / Investigator 3010

Zaragoza, 50009, Spain

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Site Ref # / Investigator 3895

Gothenburg, 41345, Sweden

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Site Ref # / Investigator 3500

Gothenburg, 416 85, Sweden

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Site Ref # / Investigator 3499

Linköping, 581 85, Sweden

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Site Ref # / Investigator 3488

Lund, 22185, Sweden

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Site Ref # / Investigator 3892

Östersund, 83183, Sweden

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Site Ref # / Investigator 3498

Skövde, 541 85, Sweden

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Site Ref # / Investigator 3489

Stockholm, 114 86, Sweden

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Site Ref # / Investigator 3896

Stockholm, 11883, Sweden

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Site Ref # / Investigator 3487

Stockholm, 171 76, Sweden

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Site Ref # / Investigator 3594

Umeå, 901 85, Sweden

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Site Ref # / Investigator 3323

Basel, 4031, Switzerland

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Site Ref # / Investigator 3321

Bern, 3010, Switzerland

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Site Ref # / Investigator 3322

Lausanne, 1011, Switzerland

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Site Ref # / Investigator 3794

Zurich, 8091, Switzerland

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Site Ref # / Investigator 4604

Barnstaple, EX31 4JB, United Kingdom

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Site Ref # / Investigator 4590

Cardiff, CF14 4XW, United Kingdom

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Site Ref # / Investigator 4603

Dundee, DD1 9SY, United Kingdom

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Site Ref # / Investigator 4579

Edinburgh, EH4 2XU, United Kingdom

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Site Ref # / Investigator 4588

Harrow, HA1 3UJ, United Kingdom

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Site Ref # / Investigator 4586

Liverpool, L7 8XP, United Kingdom

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Site Ref # / Investigator 4595

London, NW1 2BU, United Kingdom

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Site Ref # / Investigator 4607

London, SE1 7EH, United Kingdom

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Site Ref # / Investigator 4596

London, SE5 9RS, United Kingdom

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Site Ref # / Investigator 4580

London, W12 ONN, United Kingdom

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Site Ref # / Investigator 4591

Nottingham, NG7 2UH, United Kingdom

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Site Ref # / Investigator 4589

Plymouth, PL6 8DH, United Kingdom

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Site Ref # / Investigator 4592

Portsmouth, PO6 3LY, United Kingdom

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Site Ref # / Investigator 4597

Rotherham, S60 2UD, United Kingdom

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Site Ref # / Investigator 4584

Sheffield, S10 2JF, United Kingdom

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Site Ref # / Investigator 4578

Southampton, SO16 6YD, United Kingdom

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Site Ref # / Investigator 4598

Stockport, SK2 7JE, United Kingdom

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Site Ref # / Investigator 4581

Surrey, CR7 7YE, United Kingdom

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Related Publications (1)

• 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.

  PMID: 22480772 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Paul Pollack, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 11, 2006
• Study Start: December 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 10, 2011
• Results First Posted: September 2, 2009

Record last verified: 2011-10

Locations

CZ (4); NO (5); FR (30); IE (3); SE (10); CH (4); DK (5); DE (48); GB (18); IT (13); AU (5); BE (8); FI (1); PT (4); ES (20); GR (8); SL (3)