/ Research Experience

Principle Investigator for the clinical trials:

2018/2019 : GS-US- 419-3895 (DIVERSITY1) : Combined Phase 3, Double blind, Randomized, Placebo controlled studies evaluating the Efficacy and Safety of Filgotinib in the induction and maintenance of remission in Moderately to severely active Crohns disease

2018/ 2019: GS - US- 419-3896 (DIVERSITY LTE): A long term extension study to evaluate safety of Filgotinib in subjects with Crohns disease2018/2019: GS-US-418-3898 (SELECTION1): Combined Phase2b/ 3, Double blind, Randomized, Placebo controlled studies evaluating the Efficacy and Safety of Filgotinib in the induction and maintenance of remission in Moderately to severely active Ulcerative colitis

2018/2019: GS-US-418-3898 (SELECTION1): Combined Phase2b/ 3, Double blind, Randomized, Placebo controlled studies evaluating the Efficacy and Safety of Filgotinib in the induction and maintenance of remission in Moderately to severely active Ulcerative colitis

2018/2019: GS-US-418-3899 (SELECTION LTE): A long term extension study to evaluate safety of Filgotinib in subjects with Ulcerative Colitis.

Co - investigator for the following clinical trials:

2009 - The Risk of skin cancer development in Inflammatory Bowel Disease Patients on Azathioprine/6-Mercaptopurine

2009 - Psycho-sexual function, Fertility and Sperm Integrity in Men with IBD.

2008 - A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicentre Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis. Protocol C13006

2008 - A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease. Protocol C13008

2008 - A Phase III, randomised, multi-centre, double-blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (QD) with Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. Protocol SPD476-304

2008 - Study Title: A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 versus Placebo over 104 weeks in the Prevention of Recurrence of Diverticulitis. Protocol number: SPD476-313

2008 - A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. Protocol No. M06-827

2008 - A 5-Year, Registry Study of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Crohn’s Disease (CD). Protocol No.: P06-134

2008 - A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn's disease. Protocol No.: C87085

2008 - A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085. Protocol No: C87088

2007 - A Phase lll, Multicentre, Randomised, Placebo-Controlled, Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) Who Have Had Inadequate Clinical Response and/or Intolerance to Medical Therapy. Protocol No.IM101-084

2007 - A Phase lll, Multicentre, Randomised, Placebo-Controlled, Withdrawal Study to Evaluate the Clinical Efficacy and Safety of Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) Who Have Had Inadequate Clinical Response and/or Intolerance to Medical Therapy. Protocol No.IM101-108

2005 - Protocol CDP870-034: A Phase III multi-national, multi-centre, open label, 52 week safety study to assess the safety of re-exposure after a variable interval and subsequent chronic therapy with humanised anti-TNF PEG conjugated CDP870 400mg sc, (dosed at weeks 0,2 and 4 then 4-weekly to Week 48), in the treatment of patients with active Crohn’s disease who have previously been withdrawn from studies CDP870-031 or CDP870-032 due to an exacerbation of Crohn’s disease.

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