Open Label Extension Study in Crohn's Disease

• Research type

  Research Study

• Full title

  An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease.

• IRAS ID

  71505

• Contact name

  Satish Keshav

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2010-022384-35

• ISRCTN Number

  n/a

• Research summary

  The purpose of this study is to assess the safety and tolerability of GSK1605786A in subjects with Crohn??s Disease who previously had participated in a clinical trial with the same medication. Subjects who may be eligible are; those who did not achieve a response or remission in the earlier placebo-controlled induction study CCX114151 or any other GSK-sponsored induction study; subjects who completed 52 weeks of placebo treatment in the GSK sponsored extension study CCX114157; or subjects who withdrew from Study CCX114157 due to worsening of Crohn??s disease and who required a treatment change. Patients with Crohn??s Disease can have high levels of Lymphocytes (a type of White Blood Cell) in the Gastrointestinal tract, causing inflammation. GSK1605786A is an oral compound that works by blocking the recruitment of these Lymphocytes from the blood to the intestine. All subjects will enter the study at baseline and commence oral treatment with GSK1605786A 500 mg twice daily for 108 weeks. Study assessments for Crohn??s disease will be performed every 3 months. Blood tests will be performed every 2 weeks for the first 12 weeks, then every 4 weeks up to Week 52, and every 3 months thereafter. Tests will include one for pregnancy in women who might become pregnant. Other tests will include a Physical examination (including heart monitoring and assessment of any fistulae or openings of the intestine onto the skin). Subjects will be also be asked to answer questions via written questionnaires and an automated telephone system. After we have looked at the results of this study, the study duration may be extended to allow continued treatment up to the anticipated launch and availability of GSK1605786A for the treatment of Crohn??s disease.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/H0604/1

• Date of REC Opinion

  22 Mar 2011

• REC opinion

  Further Information Favourable Opinion