M06-807,Adalimumab,Saftey,Efficay&Tolerability Crohn'sPaediatric Study

• Research type

  Research Study

• Full title

  A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study

• IRAS ID

  26662

• Contact name

  Nicholas Croft

• Sponsor organisation

  Abbott GmbH & Co. K.G.

• Eudract number

  2007006494-90

• ISRCTN Number

  n/a

• Research summary

  Crohn??s disease is a chronic (continual), debilitating disease which can effect the digestive system and the extra intestinal organs. Crohn??s disease mainly affects adults but approximately 10-15% of cases are diagnosed before Adult Childhood.Crohn??s disease is currently an incurable inflammatory disease (a disease where the body's defense system or immune system inappropriately triggers an inflammatory response when there are no foreign substances to fight off).The research question being addressed is the long term effect of the patients taking adalimumab (the investigational drug) in reducing the symptoms of Crohn??s disease.The safety and tolerability (how well the body accepts the investigational drug) after repeated administration of the adalimumab in pediatric subjects (children)diagnosed with Crohn??s is also being investigated. Subjects would have to successfully completed a previous 52 week study receiving adalimumab (M06-806). Subjects would be involved in the study for up to 114 weeks and be scheduled to come into the clinic a total of 14 visits.Adalimumab is an immunomodulator (a chemical agent that modifies the immune response of the body's immune system).Study sites will be Paediatric (Child) Gastroenterology hospital departments in the European Union and North America. There will only be one UK participating site.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/115

• Date of REC Opinion

  24 Dec 2009

• REC opinion

  Favourable Opinion