Last updated on October 2017

Vedolizumab Subcutaneous Long-Term Open-Label Extension Study


Brief description of study

The purpose of this study is to obtain long term safety and tolerability data of vedolizumab subcutaneous (vedolizumab SC) in participants with ulcerative colitis (UC) and Crohn's disease (CD).

Detailed Study Description

The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to assess its long-term safety and effectiveness in treating participants with UC or CD. This study will look at the long-term side effects and response/remission of UC and CD in participants who received vedolizumab SC in a prior vedolizumab SC study. The study will enroll up to 692 patients. All participants enrolled in this study will have previously participated in the MLN0002SC-3027 or MLN0002SC-3031 study. Participants who completed the Maintenance Period (Week 52) in their previous study, or who did not achieve a clinical response at Week 6 but who did achieve a clinical response at Week 14 after having received a third vedolizumab IV infusion at Week 6 in their previous study, will receive open-label vedolizumab SC 108 mg, once every 2 weeks (Q2W). Participants who withdrew early from the Maintenance Period of their previous study due to disease worsening or need for rescue medications will receive open-label vedolizumab SC 108 mg, once every week (QW). Participants who experience treatment failure (disease worsening or need for rescue medications while in the current study will be dose escalated to vedolizumab SC 108 mg QW. This multi-center trial will be conducted worldwide. Participation in this vedolizumab SC study will continue until vedolizumab SC becomes commercially available, the participant withdraws from the study, or the sponsor decides to close the study. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will also participate in a long-term safety follow-up, by phone, at 6 months after the last dose of study drug.

Clinical Study Identifier: NCT02620046

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Kragujevac, Serbia
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Clinical Center of Vojvodina
Novi Sad, Serbia
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Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banska Bystrica, Slovakia
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Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, Slovakia
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Gastroped s.r.o.
Kosice, Slovakia
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KM Management spol. s r.o.
Nitra, Slovakia
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Gastro I, s.r.o.
Presov, Slovakia
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Dr CCM Ziady Practice
Pretoria, South Africa
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Dr MJ Prins Practice
Cape Town, South Africa
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Dr JP Wright Practice
Cape Town, South Africa
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Hospital Universitari Germans Trias i Pujol
Badalona, Spain
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Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
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Hospital General Universitario de Alicante
Alicante, Spain
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Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain
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Hospital Universitario Ramon y Cajal
Madrid, Spain
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Complejo Hospitalario de Pontevedra
Pontevedra, Spain
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Karolinska Universitetssjukhuset - Solna
Stockholm, Sweden
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Danderyds Sjukhus AB
Stockholm, Sweden
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National Taiwan University Hospital
Taipei, Taiwan
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Mackay Memorial Hospital
Taipei, Taiwan
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Tri-Service General Hospital
Taipei, Taiwan
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Ankara University Medical Faculty
Ankara, Turkey
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Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey
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Acibadem Fulya Hospital
Istanbul, Turkey
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Haydarpasa Numune Training and Research Hospital
Istanbul, Turkey
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Marmara University Pendik Research and Training Hospital
Istanbul, Turkey
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Kocaeli Derince Training and Research Hospital
Kocaeli, Turkey
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Mersin University Medical Faculty
Mersin, Turkey
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RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
Chernivtsi, Ukraine
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SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
Dnipro, Ukraine
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Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
Ivano-Frankisk, Ukraine
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CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
Kharkiv, Ukraine
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GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, Ukraine
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CI A.and O. Tropiny City Clinical Hospital
Kherson, Ukraine
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Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
Kyiv, Ukraine
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CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, Ukraine
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MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
Kyiv, Ukraine
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Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
Lviv, Ukraine
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CI Odesa Regional Clinical Hospital
Odesa, Ukraine
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CI of TRC Ternopil University Hospital
Ternopil, Ukraine
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SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
Uzhgorod, Ukraine
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Private Small Enterprise Medical Center Pulse
Vinnytsia, Ukraine
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Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, Ukraine
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MCIC MC LLC Health Clinic
Vinnytsia, Ukraine
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SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
Zaporizhzhia, Ukraine
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Royal Devon and Exeter Hospital (Wonford)
Exeter, United Kingdom
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Whipps Cross University Hospital
London, United Kingdom
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Royal Free Hospital
London, United Kingdom
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St George's Hospital
London, United Kingdom
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Norfolk and Norwich University Hospital
Norwich, United Kingdom
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Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
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University Hospital Coventry
Coventry, United Kingdom
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Wolverhampton, United Kingdom
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