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NCT00409617 Clinical Trial

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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00409617
Other study ID # M06-829
Secondary ID EudraCT:2006-002
Status Completed
Phase Phase 3
First received December 8, 2006
Last updated October 6, 2011
Start date December 2006
Est. completion date July 2008

Study information
Verified date October 2011
Source Abbott
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 945
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• adalimumab
Adalimumab 40 mg Every Other Week dosing
• 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.

Locations
Country Name City State
Austria Site Ref # / Investigator 3077 Graz
Austria Site Ref # / Investigator 2975 Vienna
Austria Site Ref # / Investigator 2976 Vienna
Austria Site Ref # / Investigator 2978 Vienna
Austria Site Ref # / Investigator 2977 Wels
Belgium Site Ref # / Investigator 3023 Bonheiden
Belgium Site Ref # / Investigator 3021 Brussels
Belgium Site Ref # / Investigator 3074 Brussels
Belgium Site Ref # / Investigator 3020 Edegem
Belgium Site Ref # / Investigator 3625 Ghent
Belgium Site Ref # / Investigator 3773 Leuven
Belgium Site Ref # / Investigator 3022 Liege
Belgium Site Ref # / Investigator 3047 Roeselare
Czech Republic Site Ref # / Investigator 3893 Brno
Czech Republic Site Ref # / Investigator 4657 Olomouc
Czech Republic Site Ref # / Investigator 4660 Prague 5
Czech Republic Site Ref # / Investigator 4659 Prague 7
Denmark Site Ref # / Investigator 3075 Aalborg
Denmark Site Ref # / Investigator 3037 Aarhus C
Denmark Site Ref # / Investigator 3088 Helsingor
Denmark Site Ref # / Investigator 3076 Hvidovre
Denmark Site Ref # / Investigator 3019 Odense C
Finland Site Ref # / Investigator 3623 Hyvinkaa
France Site Ref # / Investigator 3032 Amiens
France Site Ref # / Investigator 3012 Besancon
France Site Ref # / Investigator 2983 Bethune
France Site Ref # / Investigator 2993 Bordeaux
France Site Ref # / Investigator 2982 Caen
France Site Ref # / Investigator 3015 Clichy
France Site Ref # / Investigator 3011 Colombes
France Site Ref # / Investigator 3030 Creteil
France Site Ref # / Investigator 3033 Creteil
France Site Ref # / Investigator 3027 Evry
France Site Ref # / Investigator 3048 Grenoble
France Site Ref # / Investigator 3097 Lille Cedex
France Site Ref # / Investigator 3031 Marseilles
France Site Ref # / Investigator 2985 Montfermeil
France Site Ref # / Investigator 2994 Montpellier
France Site Ref # / Investigator 3014 Nantes
France Site Ref # / Investigator 3029 Nice
France Site Ref # / Investigator 2995 Paris
France Site Ref # / Investigator 2996 Paris
France Site Ref # / Investigator 3016 Paris
France Site Ref # / Investigator 3017 Paris
France Site Ref # / Investigator 4275 Paris
France Site Ref # / Investigator 3025 Paris Cedex 10
France Site Ref # / Investigator 3026 Pessac Cedex
France Site Ref # / Investigator 2974 Pierre Benite
France Site Ref # / Investigator 3013 Reims
France Site Ref # / Investigator 3024 Rouen
France Site Ref # / Investigator 2973 Strasbourg
France Site Ref # / Investigator 2986 Toulouse
France Site Ref # / Investigator 3018 Vandoeuvre Les Nancy
Germany Site Ref # / Investigator 2969 Augsburg
Germany Site Ref # / Investigator 2980 Berlin
Germany Site Ref # / Investigator 3041 Berlin
Germany Site Ref # / Investigator 3070 Berlin
Germany Site Ref # / Investigator 3089 Berlin
Germany Site Ref # / Investigator 3096 Berlin
Germany Site Ref # / Investigator 3051 Bochum
Germany Site Ref # / Investigator 3084 Bochum
Germany Site Ref # / Investigator 3086 Braunschweig
Germany Site Ref # / Investigator 3094 Cottbus
Germany Site Ref # / Investigator 2972 Dachau
Germany Site Ref # / Investigator 3053 Dresden
Germany Site Ref # / Investigator 3368 Dueren
Germany Site Ref # / Investigator 3052 Erlangen
Germany Site Ref # / Investigator 3085 Essen
Germany Site Ref # / Investigator 3092 Frankfurt
Germany Site Ref # / Investigator 3040 Freiburg
Germany Site Ref # / Investigator 3066 Halle
Germany Site Ref # / Investigator 2979 Hamburg
Germany Site Ref # / Investigator 2981 Hamburg
Germany Site Ref # / Investigator 3043 Hamburg
Germany Site Ref # / Investigator 3044 Hamburg
Germany Site Ref # / Investigator 3082 Hamburg
Germany Site Ref # / Investigator 3081 Hannover
Germany Site Ref # / Investigator 3072 Heidelberg
Germany Site Ref # / Investigator 3093 Herne
Germany Site Ref # / Investigator 3080 Jena
Germany Site Ref # / Investigator 3034 Karlsruhe
Germany Site Ref # / Investigator 3617 Kiel
Germany Site Ref # / Investigator 3071 Leipzig
Germany Site Ref # / Investigator 3091 Luebeck
Germany Site Ref # / Investigator 3090 Magdeburg
Germany Site Ref # / Investigator 3049 Mainz
Germany Site Ref # / Investigator 3083 Mainz
Germany Site Ref # / Investigator 3073 Mannheim
Germany Site Ref # / Investigator 3050 Minden
Germany Site Ref # / Investigator 3056 Muenster
Germany Site Ref # / Investigator 3057 Muenster
Germany Site Ref # / Investigator 3054 Munich
Germany Site Ref # / Investigator 3055 Munich
Germany Site Ref # / Investigator 3098 Munich
Germany Site Ref # / Investigator 3046 Osnabrueck
Germany Site Ref # / Investigator 3078 Regensburg
Germany Site Ref # / Investigator 3095 Rostock
Germany Site Ref # / Investigator 2970 Rottenburg
Germany Site Ref # / Investigator 3042 Stade
Germany Site Ref # / Investigator 3045 Stuttgart
Germany Site Ref # / Investigator 3079 Stuttgart
Greece Site Ref # / Investigator 4352 Athens
Greece Site Ref # / Investigator 4357 Athens
Greece Site Ref # / Investigator 4358 Athens
Greece Site Ref # / Investigator 4606 Heraklion
Greece Site Ref # / Investigator 4355 Ioannina
Greece Site Ref # / Investigator 4353 Nikaia
Greece Site Ref # / Investigator 4351 Thessaloniki
Greece Site Ref # / Investigator 4359 Thessaloniki
Ireland Site Ref # / Investigator 3326 Cork
Ireland Site Ref # / Investigator 3325 Dublin 24
Ireland Site Ref # / Investigator 3324 Dublin 9
Italy Site Ref # / Investigator 3953 Bologna
Italy Site Ref # / Investigator 3061 Florence
Italy Site Ref # / Investigator 3035 Milan
Italy Site Ref # / Investigator 3065 Naples
Italy Site Ref # / Investigator 3036 Padova
Italy Site Ref # / Investigator 3062 Palermo
Italy Site Ref # / Investigator 3063 Pavia
Italy Site Ref # / Investigator 3058 Pescara
Italy Site Ref # / Investigator 2991 Rome
Italy Site Ref # / Investigator 3039 Rome
Italy Site Ref # / Investigator 3064 Rome
Italy Site Ref # / Investigator 3087 Rozzano
Italy Site Ref # / Investigator 3038 San Donato Milanese
Norway Site Ref # / Investigator 3618 Bergen
Norway Site Ref # / Investigator 3629 Bodo
Norway Site Ref # / Investigator 3630 Hamar
Norway Site Ref # / Investigator 3619 Oslo
Norway Site Ref # / Investigator 3620 Oslo
Portugal Site Ref # / Investigator 3596 Braga
Portugal Site Ref # / Investigator 3069 Coimbra
Portugal Site Ref # / Investigator 3068 Lisbon
Portugal Site Ref # / Investigator 4972 Lisbon
Slovakia Site Ref # / Investigator 3493 Bratislava
Slovakia Site Ref # / Investigator 4626 Kosice
Slovakia Site Ref # / Investigator 3494 Presov
Spain Site Ref # / Investigator 3448 Alicante
Spain Site Ref # / Investigator 3009 Badalona - Barcelona
Spain Site Ref # / Investigator 3005 Barakaldo
Spain Site Ref # / Investigator 2989 Barcelona
Spain Site Ref # / Investigator 2990 Barcelona
Spain Site Ref # / Investigator 3002 Barcelona
Spain Site Ref # / Investigator 3486 Barcelona
Spain Site Ref # / Investigator 2998 Cabuenes-Gijon
Spain Site Ref # / Investigator 2988 Galdakano
Spain Site Ref # / Investigator 4383 Las Palmas de Gran Canaria
Spain Site Ref # / Investigator 2997 Madrid
Spain Site Ref # / Investigator 2999 Madrid
Spain Site Ref # / Investigator 3447 Madrid
Spain Site Ref # / Investigator 3484 Madrid
Spain Site Ref # / Investigator 3595 Madrid
Spain Site Ref # / Investigator 3008 Palma de Mallorca
Spain Site Ref # / Investigator 3000 Santander
Spain Site Ref # / Investigator 3003 Valencia
Spain Site Ref # / Investigator 3007 Zaragoza
Spain Site Ref # / Investigator 3010 Zaragoza
Sweden Site Ref # / Investigator 3500 Gothenburg
Sweden Site Ref # / Investigator 3895 Gothenburg
Sweden Site Ref # / Investigator 3499 Linkoping
Sweden Site Ref # / Investigator 3488 Lund
Sweden Site Ref # / Investigator 3892 Oestersund
Sweden Site Ref # / Investigator 3498 Skoevde
Sweden Site Ref # / Investigator 3487 Stockholm
Sweden Site Ref # / Investigator 3489 Stockholm
Sweden Site Ref # / Investigator 3896 Stockholm
Sweden Site Ref # / Investigator 3594 Umea
Switzerland Site Ref # / Investigator 3323 Basel
Switzerland Site Ref # / Investigator 3321 Bern
Switzerland Site Ref # / Investigator 3322 Lausanne
Switzerland Site Ref # / Investigator 3794 Zurich
United Kingdom Site Ref # / Investigator 4604 Barnstaple
United Kingdom Site Ref # / Investigator 4590 Cardiff
United Kingdom Site Ref # / Investigator 4603 Dundee
United Kingdom Site Ref # / Investigator 4579 Edinburgh
United Kingdom Site Ref # / Investigator 4588 Harrow
United Kingdom Site Ref # / Investigator 4586 Liverpool
United Kingdom Site Ref # / Investigator 4580 London
United Kingdom Site Ref # / Investigator 4595 London
United Kingdom Site Ref # / Investigator 4596 London
United Kingdom Site Ref # / Investigator 4607 London
United Kingdom Site Ref # / Investigator 4591 Nottingham
United Kingdom Site Ref # / Investigator 4589 Plymouth
United Kingdom Site Ref # / Investigator 4592 Portsmouth
United Kingdom Site Ref # / Investigator 4597 Rotherham
United Kingdom Site Ref # / Investigator 4584 Sheffield
United Kingdom Site Ref # / Investigator 4578 Southampton
United Kingdom Site Ref # / Investigator 4598 Stockport
United Kingdom Site Ref # / Investigator 4581 Surrey

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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). Week 20 of treatment No
Secondary 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. Week 20 of treatment No
Secondary 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. Week 20 of treatment No
Secondary 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. Week 20 of treatment No
Secondary 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. Week 20 of treatment No
Secondary 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. Week 20 of treatment No
Secondary 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). Week 20 of treatment No
Secondary 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. Week 20 of treatment No
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