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Crohn's DiseasePhase 3NCT00409617

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

A Phase 3 study testing adalimumab in people with Crohn's Disease, run by Abbott at 189 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
adalimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
945 participants
Where
189 sitesin 17 countries
Study dates
Dec 2006to Jul 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

189 sites in 17 countries.

189 sites in 17 countries

Germany48 sites

  • Site Ref # / Investigator 2969

    Augsburg, D-86156

  • Site Ref # / Investigator 3096

    Berlin, 10117

  • Site Ref # / Investigator 3041

    Berlin, 10367

  • Site Ref # / Investigator 3070

    Berlin, 12200

  • Site Ref # / Investigator 2980

    Berlin, 13353

  • Site Ref # / Investigator 3089

    Berlin, 14089

  • Site Ref # / Investigator 3084

    Bochum, 44791

  • Site Ref # / Investigator 3051

    Bochum, D-44789

  • Site Ref # / Investigator 3086

    Braunschweig, 38126

  • Site Ref # / Investigator 3094

    Cottbus, D-03048

  • Site Ref # / Investigator 2972

    Dachau, 85221

  • Site Ref # / Investigator 3053

    Dresden, 01067

  • Site Ref # / Investigator 3368

    Düren, 52351

  • Site Ref # / Investigator 3052

    Erlangen, D-91054

  • Site Ref # / Investigator 3085

    Essen, D-45239

  • Site Ref # / Investigator 3092

    Frankfurt, 60318

  • Site Ref # / Investigator 3040

    Freiburg im Breisgau, D-79106

  • Site Ref # / Investigator 3066

    Halle, 06120

  • Site Ref # / Investigator 2981

    Hamburg, 20148

  • Site Ref # / Investigator 3044

    Hamburg, 20148

  • Site Ref # / Investigator 2979

    Hamburg, 20246

  • Site Ref # / Investigator 3043

    Hamburg, 22297

  • Site Ref # / Investigator 3082

    Hamburg, 22559

  • Site Ref # / Investigator 3081

    Hanover, 30625

  • Site Ref # / Investigator 3072

    Heidelberg, 69120

  • Site Ref # / Investigator 3093

    Herne, 44623

  • Site Ref # / Investigator 3080

    Jena, 07747

  • Site Ref # / Investigator 3034

    Karlsruhe, 76133

  • Site Ref # / Investigator 3617

    Kiel, 24105

  • Site Ref # / Investigator 3071

    Leipzig, 04103

  • Site Ref # / Investigator 3091

    Lübeck, 23538

  • Site Ref # / Investigator 3090

    Magdeburg, 39120

  • Site Ref # / Investigator 3049

    Mainz, 55116

  • Site Ref # / Investigator 3083

    Mainz, 55131

  • Site Ref # / Investigator 3073

    Mannheim, 68161

  • Site Ref # / Investigator 3050

    Minden, 32423

  • Site Ref # / Investigator 3098

    Munich, 80639

  • Site Ref # / Investigator 3055

    Munich, 81377

  • Site Ref # / Investigator 3054

    Munich, 81925

  • Site Ref # / Investigator 3056

    Münster, 48129

  • Site Ref # / Investigator 3057

    Münster, 48159

  • Site Ref # / Investigator 3046

    Osnabrück, 49076

  • Site Ref # / Investigator 3078

    Regensburg, 93053

  • Site Ref # / Investigator 3095

    Rostock, 18057

  • Site Ref # / Investigator 2970

    Rottenburg, 72108

  • Site Ref # / Investigator 3042

    Stade, 21682

  • Site Ref # / Investigator 3045

    Stuttgart, 70565

  • Site Ref # / Investigator 3079

    Stuttgart, D-70376

Other trials in Germany

France30 sites

  • Site Ref # / Investigator 3032

    Amiens, 80054

  • Site Ref # / Investigator 3012

    Besançon, 25000

  • Site Ref # / Investigator 2983

    Béthune, 62408

  • Site Ref # / Investigator 2993

    Bordeaux, 33075

  • Site Ref # / Investigator 2982

    Caen, 14033

  • Site Ref # / Investigator 3015

    Clichy, 92110

  • Site Ref # / Investigator 3011

    Colombes, 92701

  • Site Ref # / Investigator 3030

    Créteil, 94010

  • Site Ref # / Investigator 3033

    Créteil, 94010

  • Site Ref # / Investigator 3027

    Évry, 91014

  • Site Ref # / Investigator 3048

    Grenoble, 38043

  • Site Ref # / Investigator 3097

    Lille, 59037

  • Site Ref # / Investigator 3031

    Marseille, 13015

  • Site Ref # / Investigator 2985

    Montfermeil, 93370

  • Site Ref # / Investigator 2994

    Montpellier, 34000

  • Site Ref # / Investigator 3014

    Nantes, 44035

  • Site Ref # / Investigator 3029

    Nice, 06202

  • Site Ref # / Investigator 3017

    Paris, 75014

  • Site Ref # / Investigator 2995

    Paris, 75018

  • Site Ref # / Investigator 3025

    Paris, 75475

  • Site Ref # / Investigator 2996

    Paris, 75571

  • Site Ref # / Investigator 3016

    Paris, 75679

  • Site Ref # / Investigator 4275

    Paris, 75908

  • Site Ref # / Investigator 3026

    Pessac, 33600

  • Site Ref # / Investigator 2974

    Pierre-Bénite, 69495

  • Site Ref # / Investigator 3013

    Reims, 51092

  • Site Ref # / Investigator 3024

    Rouen, 76031

  • Site Ref # / Investigator 2973

    Strasbourg, 67089

  • Site Ref # / Investigator 2986

    Toulouse, 31059

  • Site Ref # / Investigator 3018

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain20 sites

  • Site Ref # / Investigator 3448

    Alicante, 03010

  • Site Ref # / Investigator 3009

    Badalona - Barcelona, 08916

  • Site Ref # / Investigator 3005

    Barakaldo, 48903

  • Site Ref # / Investigator 2990

    Barcelona, 08003

  • Site Ref # / Investigator 2989

    Barcelona, 08035

  • Site Ref # / Investigator 3002

    Barcelona, 08036

  • Site Ref # / Investigator 3486

    Barcelona, 08097

  • Site Ref # / Investigator 2998

    Cabuenes-Gijon, 33203

  • Site Ref # / Investigator 2988

    Galdakano, 48960

  • Site Ref # / Investigator 4383

    Las Palmas de Gran Canaria, 35020

  • Site Ref # / Investigator 3484

    Madrid, 28035

  • Site Ref # / Investigator 2997

    Madrid, 28040

  • Site Ref # / Investigator 2999

    Madrid, 28041

  • Site Ref # / Investigator 3447

    Madrid, 28046

  • Site Ref # / Investigator 3595

    Madrid, 28299

  • Site Ref # / Investigator 3008

    Palma de Mallorca, 07014

  • Site Ref # / Investigator 3000

    Santander, 39008

  • Site Ref # / Investigator 3003

    Valencia, 46010

  • Site Ref # / Investigator 3007

    Zaragoza, 50009

  • Site Ref # / Investigator 3010

    Zaragoza, 50009

Other trials in Spain

United Kingdom18 sites

  • Site Ref # / Investigator 4604

    Barnstaple, EX31 4JB

  • Site Ref # / Investigator 4590

    Cardiff, CF14 4XW

  • Site Ref # / Investigator 4603

    Dundee, DD1 9SY

  • Site Ref # / Investigator 4579

    Edinburgh, EH4 2XU

  • Site Ref # / Investigator 4588

    Harrow, HA1 3UJ

  • Site Ref # / Investigator 4586

    Liverpool, L7 8XP

  • Site Ref # / Investigator 4595

    London, NW1 2BU

  • Site Ref # / Investigator 4607

    London, SE1 7EH

  • Site Ref # / Investigator 4596

    London, SE5 9RS

  • Site Ref # / Investigator 4580

    London, W12 ONN

  • Site Ref # / Investigator 4591

    Nottingham, NG7 2UH

  • Site Ref # / Investigator 4589

    Plymouth, PL6 8DH

  • Site Ref # / Investigator 4592

    Portsmouth, PO6 3LY

  • Site Ref # / Investigator 4597

    Rotherham, S60 2UD

  • Site Ref # / Investigator 4584

    Sheffield, S10 2JF

  • Site Ref # / Investigator 4578

    Southampton, SO16 6YD

  • Site Ref # / Investigator 4598

    Stockport, SK2 7JE

  • Site Ref # / Investigator 4581

    Surrey, CR7 7YE

Other trials in United Kingdom

Italy13 sites

  • Site Ref # / Investigator 3953

    Bologna, 40138

  • Site Ref # / Investigator 3061

    Florence, 50134

  • Site Ref # / Investigator 3035

    Milan, 20157

  • Site Ref # / Investigator 3065

    Naples, 80131

  • Site Ref # / Investigator 3036

    Padova, 35128

  • Site Ref # / Investigator 3062

    Palermo, 90146

  • Site Ref # / Investigator 3063

    Pavia, 27100

  • Site Ref # / Investigator 3058

    Pescara, 65100

  • Site Ref # / Investigator 3064

    Rome, 00133

  • Site Ref # / Investigator 2991

    Rome, 00152

  • Site Ref # / Investigator 3039

    Rome, 00186

  • Site Ref # / Investigator 3087

    Rozzano, 20089

  • Site Ref # / Investigator 3038

    San Donato Milanese, 20097

Other trials in Italy

Sweden10 sites

  • Site Ref # / Investigator 3895

    Gothenburg, 41345

  • Site Ref # / Investigator 3500

    Gothenburg, 416 85

  • Site Ref # / Investigator 3499

    Linköping, 581 85

  • Site Ref # / Investigator 3488

    Lund, 22185

  • Site Ref # / Investigator 3892

    Östersund, 83183

  • Site Ref # / Investigator 3498

    Skövde, 541 85

  • Site Ref # / Investigator 3489

    Stockholm, 114 86

  • Site Ref # / Investigator 3896

    Stockholm, 11883

  • Site Ref # / Investigator 3487

    Stockholm, 171 76

  • Site Ref # / Investigator 3594

    Umeå, 901 85

Other trials in Sweden

Belgium8 sites

  • Site Ref # / Investigator 3023

    Bonheiden, 2820

  • Site Ref # / Investigator 3021

    Brussels, 1090

  • Site Ref # / Investigator 3074

    Brussels, 1200

  • Site Ref # / Investigator 3020

    Edegem, 2650

  • Site Ref # / Investigator 3625

    Ghent, 9000

  • Site Ref # / Investigator 3773

    Leuven, 3000

  • Site Ref # / Investigator 3022

    Liège, 4000

  • Site Ref # / Investigator 3047

    Roeselare, 8800

Other trials in Belgium

Greece8 sites

  • Site Ref # / Investigator 4352

    Athens, 106 76

  • Site Ref # / Investigator 4357

    Athens, 106-76

  • Site Ref # / Investigator 4358

    Athens, 124 62

  • Site Ref # / Investigator 4606

    Heraklion, 71100

  • Site Ref # / Investigator 4355

    Ioannina, 45500

  • Site Ref # / Investigator 4353

    Nikaia, 184 54

  • Site Ref # / Investigator 4359

    Thessaloniki, 54642

  • Site Ref # / Investigator 4351

    Thessaloniki, 57010

Other trials in Greece

Austria5 sites

  • Site Ref # / Investigator 3077

    Graz, 8036

  • Site Ref # / Investigator 2978

    Vienna, 1030

  • Site Ref # / Investigator 2975

    Vienna, 1060

  • Site Ref # / Investigator 2976

    Vienna, 1090

  • Site Ref # / Investigator 2977

    Wels, A-4600

Other trials in Austria

Denmark5 sites

  • Site Ref # / Investigator 3075

    Aalborg, 9000

  • Site Ref # / Investigator 3037

    Aarhus C, 8000

  • Site Ref # / Investigator 3088

    Elsinore, 3000

  • Site Ref # / Investigator 3076

    Hvidovre, 2650

  • Site Ref # / Investigator 3019

    Odense C, 5000

Other trials in Denmark

Norway5 sites

  • Site Ref # / Investigator 3618

    Bergen, 5021

  • Site Ref # / Investigator 3629

    Bodø, N-8092

  • Site Ref # / Investigator 3630

    Hamar, N-2326

  • Site Ref # / Investigator 3620

    Oslo, 0370

  • Site Ref # / Investigator 3619

    Oslo, 0514

Other trials in Norway

Czechia4 sites

  • Site Ref # / Investigator 3893

    Brno, 62500

  • Site Ref # / Investigator 4657

    Olomouc, 77520

  • Site Ref # / Investigator 4660

    Prague, 15006

  • Site Ref # / Investigator 4659

    Prague, 17000

Other trials in Czechia

Portugal4 sites

  • Site Ref # / Investigator 3596

    Braga, 4700-308

  • Site Ref # / Investigator 3069

    Coimbra, 3000-075

  • Site Ref # / Investigator 4972

    Lisbon, 1150-069

  • Site Ref # / Investigator 3068

    Lisbon, 1649-035

Other trials in Portugal

Switzerland4 sites

  • Site Ref # / Investigator 3323

    Basel, 4031

  • Site Ref # / Investigator 3321

    Bern, 3010

  • Site Ref # / Investigator 3322

    Lausanne, 1011

  • Site Ref # / Investigator 3794

    Zurich, 8091

Other trials in Switzerland

Ireland3 sites

  • Site Ref # / Investigator 3326

    Cork

  • Site Ref # / Investigator 3324

    Dublin

  • Site Ref # / Investigator 3325

    Dublin

Other trials in Ireland

Slovakia3 sites

  • Site Ref # / Investigator 3493

    Bratislava, SK-813 69

  • Site Ref # / Investigator 4626

    Košice, 04001

  • Site Ref # / Investigator 3494

    Prešov, 08001

Other trials in Slovakia

Finland1 site

  • Site Ref # / Investigator 3623

    Hyvinkää, 05850

Other trials in Finland

About this study

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

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.

Read the 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).

Conditions
Crohn's Disease
Being tested
adalimumab
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adalimumabBiological

    Also called Humira

    Adalimumab 40 mg Every Other Week dosing

  • adalimumabBiological

    Also called Humira

    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.

Study groups in NCT00409617
Study groupRoleWhat they receive
Open LabelExperimentalNot described
Receives: Biological: adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Week 20 of treatment

Secondary outcomes (8)

  1. 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).

    Measured: Week 20 of treatment

  2. 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.

    Measured: Week 20 of treatment

  3. 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.

    Measured: Week 20 of treatment

  4. 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.

    Measured: Week 20 of treatment

  5. 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.

    Measured: Week 20 of treatment

  6. 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.

    Measured: Week 20 of treatment

  7. 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).

    Measured: Week 20 of treatment

  8. 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.

    Measured: Week 20 of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
945 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00409617
Sponsor's protocol ID
M06-829
Other IDs
EudraCT:2006-002078-23
Status last verified
Oct 2011
First submitted
8 Dec 2006
Last updated
10 Oct 2011
Data monitoring committee
No

Publications

  • 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.

    PubMed 22480772

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adalimumab in people with Crohn's Disease, run by Abbott at 189 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in Germany, France, Spain, United Kingdom, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00409617, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2011.

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