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

NCT ID: NCT00409617

Last Updated: 2011-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

945 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-07-31

Brief Summary

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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

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If the subject continues to demonstrate a lack of improvement on every week adalimumab therapy, they may be withdrawn from the study.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

Conditions

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Crohn's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label

Group Type EXPERIMENTAL

adalimumab

Intervention Type BIOLOGICAL

Adalimumab 40 mg Every Other Week dosing

adalimumab

Intervention Type BIOLOGICAL

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.

Interventions

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adalimumab

Adalimumab 40 mg Every Other Week dosing

Intervention Type 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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Humira Humira

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Pollack, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Ref # / Investigator 3077

Graz, , Austria

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Site Ref # / Investigator 2978

Vienna, , Austria

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Site Ref # / Investigator 2975

Vienna, , Austria

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Site Ref # / Investigator 2976

Vienna, , Austria

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Site Ref # / Investigator 2977

Wels, , Austria

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Site Ref # / Investigator 3023

Bonheiden, , Belgium

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Site Ref # / Investigator 3021

Brussels, , Belgium

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Site Ref # / Investigator 3074

Brussels, , Belgium

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Site Ref # / Investigator 3020

Edegem, , Belgium

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Site Ref # / Investigator 3625

Ghent, , Belgium

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Site Ref # / Investigator 3773

Leuven, , Belgium

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Site Ref # / Investigator 3022

Liège, , Belgium

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Site Ref # / Investigator 3047

Roeselare, , Belgium

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Site Ref # / Investigator 3893

Brno, , Czechia

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Site Ref # / Investigator 4657

Olomouc, , Czechia

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Site Ref # / Investigator 4660

Prague, , Czechia

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Site Ref # / Investigator 4659

Prague, , Czechia

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Site Ref # / Investigator 3075

Aalborg, , Denmark

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Site Ref # / Investigator 3037

Aarhus C, , Denmark

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Site Ref # / Investigator 3088

Elsinore, , Denmark

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Site Ref # / Investigator 3076

Hvidovre, , Denmark

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Site Ref # / Investigator 3019

Odense C, , Denmark

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Site Ref # / Investigator 3623

Hyvinkää, , Finland

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Site Ref # / Investigator 3032

Amiens, , France

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Site Ref # / Investigator 3012

Besançon, , France

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Site Ref # / Investigator 2983

Béthune, , France

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Site Ref # / Investigator 2993

Bordeaux, , France

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Site Ref # / Investigator 2982

Caen, , France

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Site Ref # / Investigator 3015

Clichy, , France

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Site Ref # / Investigator 3011

Colombes, , France

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Site Ref # / Investigator 3030

Créteil, , France

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Site Ref # / Investigator 3033

Créteil, , France

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Site Ref # / Investigator 3027

Évry, , France

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Site Ref # / Investigator 3048

Grenoble, , France

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Site Ref # / Investigator 3097

Lille, , France

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Site Ref # / Investigator 3031

Marseille, , France

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Site Ref # / Investigator 2985

Montfermeil, , France

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Site Ref # / Investigator 2994

Montpellier, , France

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Site Ref # / Investigator 3014

Nantes, , France

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Site Ref # / Investigator 3029

Nice, , France

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Site Ref # / Investigator 3017

Paris, , France

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Site Ref # / Investigator 2995

Paris, , France

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Site Ref # / Investigator 3025

Paris, , France

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Site Ref # / Investigator 2996

Paris, , France

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Site Ref # / Investigator 3016

Paris, , France

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Site Ref # / Investigator 4275

Paris, , France

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Site Ref # / Investigator 3026

Pessac, , France

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Site Ref # / Investigator 2974

Pierre-Bénite, , France

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Site Ref # / Investigator 3013

Reims, , France

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Site Ref # / Investigator 3024

Rouen, , France

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Site Ref # / Investigator 2973

Strasbourg, , France

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Site Ref # / Investigator 2986

Toulouse, , France

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Site Ref # / Investigator 3018

Vandœuvre-lès-Nancy, , France

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Site Ref # / Investigator 2969

Augsburg, , Germany

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Site Ref # / Investigator 3096

Berlin, , Germany

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Site Ref # / Investigator 3041

Berlin, , Germany

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Site Ref # / Investigator 3070

Berlin, , Germany

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Site Ref # / Investigator 2980

Berlin, , Germany

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Site Ref # / Investigator 3089

Berlin, , Germany

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Site Ref # / Investigator 3084

Bochum, , Germany

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Site Ref # / Investigator 3051

Bochum, , Germany

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Site Ref # / Investigator 3086

Braunschweig, , Germany

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Site Ref # / Investigator 3094

Cottbus, , Germany

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Site Ref # / Investigator 2972

Dachau, , Germany

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Site Ref # / Investigator 3053

Dresden, , Germany

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Site Ref # / Investigator 3368

Düren, , Germany

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Site Ref # / Investigator 3052

Erlangen, , Germany

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Site Ref # / Investigator 3085

Essen, , Germany

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Site Ref # / Investigator 3092

Frankfurt, , Germany

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Site Ref # / Investigator 3040

Freiburg im Breisgau, , Germany

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Site Ref # / Investigator 3066

Halle, , Germany

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Site Ref # / Investigator 2981

Hamburg, , Germany

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Site Ref # / Investigator 3044

Hamburg, , Germany

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Site Ref # / Investigator 2979

Hamburg, , Germany

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Site Ref # / Investigator 3043

Hamburg, , Germany

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Site Ref # / Investigator 3082

Hamburg, , Germany

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Site Ref # / Investigator 3081

Hanover, , Germany

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Site Ref # / Investigator 3072

Heidelberg, , Germany

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Site Ref # / Investigator 3093

Herne, , Germany

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Site Ref # / Investigator 3080

Jena, , Germany

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Site Ref # / Investigator 3034

Karlsruhe, , Germany

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Site Ref # / Investigator 3617

Kiel, , Germany

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Site Ref # / Investigator 3071

Leipzig, , Germany

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Site Ref # / Investigator 3091

Lübeck, , Germany

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Site Ref # / Investigator 3090

Magdeburg, , Germany

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Site Ref # / Investigator 3049

Mainz, , Germany

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Site Ref # / Investigator 3083

Mainz, , Germany

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Site Ref # / Investigator 3073

Mannheim, , Germany

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Site Ref # / Investigator 3050

Minden, , Germany

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Site Ref # / Investigator 3098

Munich, , Germany

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Site Ref # / Investigator 3055

Munich, , Germany

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Site Ref # / Investigator 3054

Munich, , Germany

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Site Ref # / Investigator 3056

Münster, , Germany

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Site Ref # / Investigator 3057

Münster, , Germany

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Site Ref # / Investigator 3046

Osnabrück, , Germany

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Site Ref # / Investigator 3078

Regensburg, , Germany

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Site Ref # / Investigator 3095

Rostock, , Germany

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Site Ref # / Investigator 2970

Rottenburg, , Germany

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Site Ref # / Investigator 3042

Stade, , Germany

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Site Ref # / Investigator 3045

Stuttgart, , Germany

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Site Ref # / Investigator 3079

Stuttgart, , Germany

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Site Ref # / Investigator 4352

Athens, , Greece

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Site Ref # / Investigator 4357

Athens, , Greece

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Site Ref # / Investigator 4358

Athens, , Greece

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Site Ref # / Investigator 4606

Heraklion, , Greece

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Site Ref # / Investigator 4355

Ioannina, , Greece

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Site Ref # / Investigator 4353

Nikaia, , Greece

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Site Ref # / Investigator 4359

Thessaloniki, , Greece

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Site Ref # / Investigator 4351

Thessaloniki, , 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, , Italy

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Site Ref # / Investigator 3061

Florence, , Italy

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Site Ref # / Investigator 3035

Milan, , Italy

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Site Ref # / Investigator 3065

Naples, , Italy

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Site Ref # / Investigator 3036

Padua, , Italy

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Site Ref # / Investigator 3062

Palermo, , Italy

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Site Ref # / Investigator 3063

Pavia, , Italy

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Site Ref # / Investigator 3058

Pescara, , Italy

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Site Ref # / Investigator 3064

Rome, , Italy

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Site Ref # / Investigator 2991

Rome, , Italy

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Site Ref # / Investigator 3039

Rome, , Italy

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Site Ref # / Investigator 3087

Rozzano, , Italy

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Site Ref # / Investigator 3038

San Donato Milanese, , Italy

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Site Ref # / Investigator 3618

Bergen, , Norway

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Site Ref # / Investigator 3629

Bodø, , Norway

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Site Ref # / Investigator 3630

Hamar, , Norway

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Site Ref # / Investigator 3620

Oslo, , Norway

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Site Ref # / Investigator 3619

Oslo, , Norway

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Site Ref # / Investigator 3596

Braga, , Portugal

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Site Ref # / Investigator 3069

Coimbra, , Portugal

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Site Ref # / Investigator 4972

Lisbon, , Portugal

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Site Ref # / Investigator 3068

Lisbon, , Portugal

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Site Ref # / Investigator 3493

Bratislava, , Slovakia

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Site Ref # / Investigator 4626

Košice, , Slovakia

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Site Ref # / Investigator 3494

Prešov, , Slovakia

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Site Ref # / Investigator 3448

Alicante, , Spain

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Site Ref # / Investigator 3009

Badalona - Barcelona, , Spain

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Site Ref # / Investigator 3005

Barakaldo, , Spain

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Site Ref # / Investigator 2990

Barcelona, , Spain

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Site Ref # / Investigator 2989

Barcelona, , Spain

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Site Ref # / Investigator 3002

Barcelona, , Spain

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Site Ref # / Investigator 3486

Barcelona, , Spain

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Site Ref # / Investigator 2998

Cabuenes-Gijon, , Spain

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Site Ref # / Investigator 2988

Galdakano, , Spain

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Site Ref # / Investigator 4383

Las Palmas de Gran Canaria, , Spain

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Site Ref # / Investigator 3484

Madrid, , Spain

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Site Ref # / Investigator 2997

Madrid, , Spain

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Site Ref # / Investigator 2999

Madrid, , Spain

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Site Ref # / Investigator 3447

Madrid, , Spain

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Site Ref # / Investigator 3595

Madrid, , Spain

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Site Ref # / Investigator 3008

Palma de Mallorca, , Spain

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Site Ref # / Investigator 3000

Santander, , Spain

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Site Ref # / Investigator 3003

Valencia, , Spain

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Site Ref # / Investigator 3007

Zaragoza, , Spain

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Site Ref # / Investigator 3010

Zaragoza, , Spain

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Site Ref # / Investigator 3895

Gothenburg, , Sweden

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Site Ref # / Investigator 3500

Gothenburg, , Sweden

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Site Ref # / Investigator 3499

Linköping, , Sweden

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Site Ref # / Investigator 3488

Lund, , Sweden

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Site Ref # / Investigator 3892

Östersund, , Sweden

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Site Ref # / Investigator 3498

Skövde, , Sweden

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Site Ref # / Investigator 3489

Stockholm, , Sweden

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Site Ref # / Investigator 3896

Stockholm, , Sweden

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Site Ref # / Investigator 3487

Stockholm, , Sweden

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Site Ref # / Investigator 3594

Umeå, , Sweden

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Site Ref # / Investigator 3323

Basel, , Switzerland

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Site Ref # / Investigator 3321

Bern, , Switzerland

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Site Ref # / Investigator 3322

Lausanne, , Switzerland

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Site Ref # / Investigator 3794

Zurich, , Switzerland

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Site Ref # / Investigator 4604

Barnstaple, , United Kingdom

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Site Ref # / Investigator 4590

Cardiff, , United Kingdom

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Site Ref # / Investigator 4603

Dundee, , United Kingdom

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Site Ref # / Investigator 4579

Edinburgh, , United Kingdom

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Site Ref # / Investigator 4588

Harrow, , United Kingdom

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Site Ref # / Investigator 4586

Liverpool, , United Kingdom

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Site Ref # / Investigator 4595

London, , United Kingdom

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Site Ref # / Investigator 4607

London, , United Kingdom

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Site Ref # / Investigator 4596

London, , United Kingdom

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Site Ref # / Investigator 4580

London, , United Kingdom

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Site Ref # / Investigator 4591

Nottingham, , United Kingdom

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Site Ref # / Investigator 4589

Plymouth, , United Kingdom

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Site Ref # / Investigator 4592

Portsmouth, , United Kingdom

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Site Ref # / Investigator 4597

Rotherham, , United Kingdom

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Site Ref # / Investigator 4584

Sheffield, , United Kingdom

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Site Ref # / Investigator 4578

Southampton, , United Kingdom

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Site Ref # / Investigator 4598

Stockport, , United Kingdom

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Site Ref # / Investigator 4581

Surrey, , United Kingdom

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Countries

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Austria Belgium Czechia Denmark Finland France Germany Greece Ireland Italy Norway Portugal Slovakia Spain Sweden Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 22480772 (View on PubMed)

Other Identifiers

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EudraCT:2006-002078-23

Identifier Type: -

Identifier Source: secondary_id

M06-829

Identifier Type: -

Identifier Source: org_study_id