Subjects with Crohn’s Disease MedDRA version: 16.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Previous participation in a GSK-sponsored study with GSK1605786A as follows: a. completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI => 100 point decrease) or clinical remission (CDAI =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is planning to become pregnant 2. Subjects with known or suspected coeliac disease or a positive screening test for antitissue transglutaminase (anti-tTG) antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tTG antibodies and excluded or withdrawn from study upon positive test result. 3. Fixed symptomatic stenoses of small bowel or colon 4. Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period 5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks 6. Use of prohibited medications at baseline and throughout the study (Section 5.4.2 of the protocol - Prohibited Medications and Non Drug Therapies) 7. Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject. 8. Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the Investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of long-term treatment with GSK1605786A in subjects with Crohn’s disease.;Secondary Objective: • To assess the effectiveness of long-term treatment with GSK1605786A • To assess changes in health-related quality of life • To assess changes in healthcare-related resource utilisation • To assess changes in work productivity and activity impairment • To assess changes in unemployment and disability rates • To assess changes in C-reactive protein (CRP) as a biomarker of inflammation • To potentially evaluate the correlation of genetic markers with the safety and effectiveness of GSK1605786A.;Primary end point(s): Safety Primary Endpoints: Incidence of adverse events/Serious adverse events;Timepoint(s) of evaluation of this end point: Safety assessments at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and post 4 week follow-up at Week 112. 12 lead ECG at Week 0, 24, 48, 72, 108 and post 4 week follow-up at Week 112. CDAI assessments at Week 0, 12, 24, 36, 48, 60, 72, 84, 96 108 and post 4 week follow-up at Week 112. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline in vital signs: heart rate and blood pressure. • Change from baseline in haematology and clinical chemistry parameters. • Change from baseline in liver function test parameters. • Change from baseline in 12 lead ECG abnormalities.;Timepoint(s) of evaluation of this end point: Safety assessments at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and post 4 week follow-up at Week 112. 12 lead ECG at Week 0, 24, 48, 72, 108 and post 4 week follow-up at Week 112. CDAI assessments at Week 0, 12, 24, 36, 48, 60, 72, 84, 96 108 and post 4 week follow-up at Week 112. | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClincial Trials HelpDesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed