DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: adalimumab (Biological); adalimumab (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Paul Pollack, MD, Study Director, Affiliation: Abbott

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.

Clinical Details

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

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

Primary outcome: Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5.

Secondary outcome:

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.

Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20

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

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

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

Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment

Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20

Mean Change in Activity Impairment Score From Baseline to Week 20

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).

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Site Ref # / Investigator 3077, Graz 8036, Austria

Site Ref # / Investigator 2975, Vienna 1060, Austria

Site Ref # / Investigator 2976, Vienna 1090, Austria

Site Ref # / Investigator 2978, Vienna 1030, Austria

Site Ref # / Investigator 2977, Wels A-4600, Austria

Site Ref # / Investigator 3023, Bonheiden 2820, Belgium

Site Ref # / Investigator 3021, Brussels 1090, Belgium

Site Ref # / Investigator 3074, Brussels 1200, Belgium

Site Ref # / Investigator 3020, Edegem 2650, Belgium

Site Ref # / Investigator 3625, Ghent 9000, Belgium

Site Ref # / Investigator 3773, Leuven 3000, Belgium

Site Ref # / Investigator 3022, Liege 4000, Belgium

Site Ref # / Investigator 3047, Roeselare 8800, Belgium

Site Ref # / Investigator 3893, Brno 62500, Czech Republic

Site Ref # / Investigator 4657, Olomouc 77520, Czech Republic

Site Ref # / Investigator 4660, Prague 5 15006, Czech Republic

Site Ref # / Investigator 4659, Prague 7 17000, Czech Republic

Site Ref # / Investigator 3075, Aalborg 9000, Denmark

Site Ref # / Investigator 3037, Aarhus C 8000, Denmark

Site Ref # / Investigator 3088, Helsingor 3000, Denmark

Site Ref # / Investigator 3076, Hvidovre 2650, Denmark

Site Ref # / Investigator 3019, Odense C 5000, Denmark

Site Ref # / Investigator 3623, Hyvinkaa 05850, Finland

Site Ref # / Investigator 3032, Amiens 80054, France

Site Ref # / Investigator 3012, Besancon 25000, France

Site Ref # / Investigator 2983, Bethune 62408, France

Site Ref # / Investigator 2993, Bordeaux 33075, France

Site Ref # / Investigator 2982, Caen 14033, France

Site Ref # / Investigator 3015, Clichy 92110, France

Site Ref # / Investigator 3011, Colombes 92701, France

Site Ref # / Investigator 3030, Creteil 94010, France

Site Ref # / Investigator 3033, Creteil 94010, France

Site Ref # / Investigator 3027, Evry 91014, France

Site Ref # / Investigator 3048, Grenoble 38043, France

Site Ref # / Investigator 3097, Lille Cedex 59037, France

Site Ref # / Investigator 3031, Marseilles 13015, France

Site Ref # / Investigator 2985, Montfermeil 93370, France

Site Ref # / Investigator 2994, Montpellier 34000, France

Site Ref # / Investigator 3014, Nantes 44035, France

Site Ref # / Investigator 3029, Nice 06202, France

Site Ref # / Investigator 3025, Paris Cedex 10 75475, France

Site Ref # / Investigator 2995, Paris 75018, France

Site Ref # / Investigator 2996, Paris 75571, France

Site Ref # / Investigator 3016, Paris 75679, France

Site Ref # / Investigator 3017, Paris 75014, France

Site Ref # / Investigator 4275, Paris 75908, France

Site Ref # / Investigator 3026, Pessac Cedex 33600, France

Site Ref # / Investigator 2974, Pierre Benite 69495, France

Site Ref # / Investigator 3013, Reims 51092, France

Site Ref # / Investigator 3024, Rouen 76031, France

Site Ref # / Investigator 2973, Strasbourg 67089, France

Site Ref # / Investigator 2986, Toulouse 31059, France

Site Ref # / Investigator 3018, Vandoeuvre Les Nancy 54511, France

Site Ref # / Investigator 2969, Augsburg D-86156, Germany

Site Ref # / Investigator 2980, Berlin 13353, Germany

Site Ref # / Investigator 3041, Berlin 10367, Germany

Site Ref # / Investigator 3070, Berlin 12200, Germany

Site Ref # / Investigator 3089, Berlin 14089, Germany

Site Ref # / Investigator 3096, Berlin 10117, Germany

Site Ref # / Investigator 3051, Bochum D-44789, Germany

Site Ref # / Investigator 3084, Bochum 44791, Germany

Site Ref # / Investigator 3086, Braunschweig 38126, Germany

Site Ref # / Investigator 3094, Cottbus D-03048, Germany

Site Ref # / Investigator 2972, Dachau 85221, Germany

Site Ref # / Investigator 3053, Dresden 01067, Germany

Site Ref # / Investigator 3368, Dueren 52351, Germany

Site Ref # / Investigator 3052, Erlangen D-91054, Germany

Site Ref # / Investigator 3085, Essen D-45239, Germany

Site Ref # / Investigator 3092, Frankfurt 60318, Germany

Site Ref # / Investigator 3040, Freiburg D-79106, Germany

Site Ref # / Investigator 3066, Halle 06120, Germany

Site Ref # / Investigator 2979, Hamburg 20246, Germany

Site Ref # / Investigator 2981, Hamburg 20148, Germany

Site Ref # / Investigator 3043, Hamburg 22297, Germany

Site Ref # / Investigator 3044, Hamburg 20148, Germany

Site Ref # / Investigator 3082, Hamburg 22559, Germany

Site Ref # / Investigator 3081, Hannover 30625, Germany

Site Ref # / Investigator 3072, Heidelberg 69120, Germany

Site Ref # / Investigator 3093, Herne 44623, Germany

Site Ref # / Investigator 3080, Jena 07747, Germany

Site Ref # / Investigator 3034, Karlsruhe 76133, Germany

Site Ref # / Investigator 3617, Kiel 24105, Germany

Site Ref # / Investigator 3071, Leipzig 04103, Germany

Site Ref # / Investigator 3091, Luebeck 23538, Germany

Site Ref # / Investigator 3090, Magdeburg 39120, Germany

Site Ref # / Investigator 3049, Mainz 55116, Germany

Site Ref # / Investigator 3083, Mainz 55131, Germany

Site Ref # / Investigator 3073, Mannheim 68161, Germany

Site Ref # / Investigator 3050, Minden 32423, Germany

Site Ref # / Investigator 3056, Muenster 48129, Germany

Site Ref # / Investigator 3057, Muenster 48159, Germany

Site Ref # / Investigator 3054, Munich 81925, Germany

Site Ref # / Investigator 3055, Munich 81377, Germany

Site Ref # / Investigator 3098, Munich 80639, Germany

Site Ref # / Investigator 3046, Osnabrueck 49076, Germany

Site Ref # / Investigator 3078, Regensburg 93053, Germany

Site Ref # / Investigator 3095, Rostock 18057, Germany

Site Ref # / Investigator 2970, Rottenburg 72108, Germany

Site Ref # / Investigator 3042, Stade 21682, Germany

Site Ref # / Investigator 3045, Stuttgart 70565, Germany

Site Ref # / Investigator 3079, Stuttgart D-70376, Germany

Site Ref # / Investigator 4352, Athens 106 76, Greece

Site Ref # / Investigator 4357, Athens 106-76, Greece

Site Ref # / Investigator 4358, Athens 124 62, Greece

Site Ref # / Investigator 4606, Heraklion 71100, Greece

Site Ref # / Investigator 4355, Ioannina 45500, Greece

Site Ref # / Investigator 4353, Nikaia 184 54, Greece

Site Ref # / Investigator 4351, Thessaloniki 57010, Greece

Site Ref # / Investigator 4359, Thessaloniki 54642, Greece

Site Ref # / Investigator 3326, Cork, Ireland

Site Ref # / Investigator 3325, Dublin 24, Ireland

Site Ref # / Investigator 3324, Dublin 9, Ireland

Site Ref # / Investigator 3953, Bologna 40138, Italy

Site Ref # / Investigator 3061, Florence 50134, Italy

Site Ref # / Investigator 3035, Milan 20157, Italy

Site Ref # / Investigator 3065, Naples 80131, Italy

Site Ref # / Investigator 3036, Padova 35128, Italy

Site Ref # / Investigator 3062, Palermo 90146, Italy

Site Ref # / Investigator 3063, Pavia 27100, Italy

Site Ref # / Investigator 3058, Pescara 65100, Italy

Site Ref # / Investigator 2991, Rome 00152, Italy

Site Ref # / Investigator 3039, Rome 00186, Italy

Site Ref # / Investigator 3064, Rome 00133, Italy

Site Ref # / Investigator 3087, Rozzano 20089, Italy

Site Ref # / Investigator 3038, San Donato Milanese 20097, Italy

Site Ref # / Investigator 3618, Bergen 5021, Norway

Site Ref # / Investigator 3629, Bodo N-8092, Norway

Site Ref # / Investigator 3630, Hamar N-2326, Norway

Site Ref # / Investigator 3619, Oslo 0514, Norway

Site Ref # / Investigator 3620, Oslo 0370, Norway

Site Ref # / Investigator 3596, Braga 4700-308, Portugal

Site Ref # / Investigator 3069, Coimbra 3000-075, Portugal

Site Ref # / Investigator 3068, Lisbon 1649-035, Portugal

Site Ref # / Investigator 4972, Lisbon 1150-069, Portugal

Site Ref # / Investigator 3493, Bratislava SK-813 69, Slovakia

Site Ref # / Investigator 4626, Kosice 04001, Slovakia

Site Ref # / Investigator 3494, Presov 08001, Slovakia

Site Ref # / Investigator 3448, Alicante 03010, Spain

Site Ref # / Investigator 3009, Badalona - Barcelona 08916, Spain

Site Ref # / Investigator 3005, Barakaldo 48903, Spain

Site Ref # / Investigator 2989, Barcelona 08035, Spain

Site Ref # / Investigator 2990, Barcelona 08003, Spain

Site Ref # / Investigator 3002, Barcelona 08036, Spain

Site Ref # / Investigator 3486, Barcelona 08097, Spain

Site Ref # / Investigator 2998, Cabuenes-Gijon 33203, Spain

Site Ref # / Investigator 2988, Galdakano 48960, Spain

Site Ref # / Investigator 4383, Las Palmas de Gran Canaria 35020, Spain

Site Ref # / Investigator 2997, Madrid 28040, Spain

Site Ref # / Investigator 2999, Madrid 28041, Spain

Site Ref # / Investigator 3447, Madrid 28046, Spain

Site Ref # / Investigator 3484, Madrid 28035, Spain

Site Ref # / Investigator 3595, Madrid 28299, Spain

Site Ref # / Investigator 3008, Palma de Mallorca 07014, Spain

Site Ref # / Investigator 3000, Santander 39008, Spain

Site Ref # / Investigator 3003, Valencia 46010, Spain

Site Ref # / Investigator 3007, Zaragoza 50009, Spain

Site Ref # / Investigator 3010, Zaragoza 50009, Spain

Site Ref # / Investigator 3500, Gothenburg 416 85, Sweden

Site Ref # / Investigator 3895, Gothenburg 41345, Sweden

Site Ref # / Investigator 3499, Linkoping 581 85, Sweden

Site Ref # / Investigator 3488, Lund 22185, Sweden

Site Ref # / Investigator 3892, Oestersund 83183, Sweden

Site Ref # / Investigator 3498, Skoevde 541 85, Sweden

Site Ref # / Investigator 3487, Stockholm 171 76, Sweden

Site Ref # / Investigator 3489, Stockholm 114 86, Sweden

Site Ref # / Investigator 3896, Stockholm 11883, Sweden

Site Ref # / Investigator 3594, Umea 901 85, Sweden

Site Ref # / Investigator 3323, Basel 4031, Switzerland

Site Ref # / Investigator 3321, Bern 3010, Switzerland

Site Ref # / Investigator 3322, Lausanne 1011, Switzerland

Site Ref # / Investigator 3794, Zurich 8091, Switzerland

Site Ref # / Investigator 4604, Barnstaple EX31 4JB, United Kingdom

Site Ref # / Investigator 4590, Cardiff CF14 4XW, United Kingdom

Site Ref # / Investigator 4603, Dundee DD1 9SY, United Kingdom

Site Ref # / Investigator 4579, Edinburgh EH4 2XU, United Kingdom

Site Ref # / Investigator 4588, Harrow HA1 3UJ, United Kingdom

Site Ref # / Investigator 4586, Liverpool L7 8XP, United Kingdom

Site Ref # / Investigator 4580, London W12 ONN, United Kingdom

Site Ref # / Investigator 4595, London NW1 2BU, United Kingdom

Site Ref # / Investigator 4596, London SE5 9RS, United Kingdom

Site Ref # / Investigator 4607, London SE1 7EH, United Kingdom

Site Ref # / Investigator 4591, Nottingham NG7 2UH, United Kingdom

Site Ref # / Investigator 4589, Plymouth PL6 8DH, United Kingdom

Site Ref # / Investigator 4592, Portsmouth PO6 3LY, United Kingdom

Site Ref # / Investigator 4597, Rotherham S60 2UD, United Kingdom

Site Ref # / Investigator 4584, Sheffield S10 2JF, United Kingdom

Site Ref # / Investigator 4578, Southampton SO16 6YD, United Kingdom

Site Ref # / Investigator 4598, Stockport SK2 7JE, United Kingdom

Site Ref # / Investigator 4581, Surrey CR7 7YE, United Kingdom

Additional Information

Starting date: December 2006
Last updated: October 6, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017