Crohn's disease inflammatory bowel disease
Conditions
Interventions
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: Part 1 (OLE) • Patients who were previously enrolled in Study GA29144 and experienced any of the following: Disease worsening in the Induction Phase of Study GA29144, defined as both CDAI and PRO2 scores at Week 10 or later in the Induction Phase being greater than the patient*s baseline (Week 0) score Did not achieve CDAI-70 response at Week 14 in Study GA29144 A clinical relapse in Study GA29144, defined as >= 100-point increase in CDAI score from the Week 14 CDAI score on two consecutive visits (which may include unscheduled visits) and a CDAI score >= 220 points Completed the Maintenance Phase including the Week 74 clinic visit in Study GA29144 • Ability and willingness to provide written informed consent and comply with the requirements of the OLE-SM protocol. • For women who are not postmenopausal (at least 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or to use a highly effective method of contraception during the treatment period and for at least 24 weeks after the last dose of study drug. Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. • For men: agreement to remain abstinent or to use a condom during the treatment period and for at least 24 weeks after the last dose of study drug Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. PART 2 (SM) • Patients who participated in Study GA29144 and are not eligible or chose not to enroll in Part 1 (OLE) • Patients who participated in Part 1 (OLE) of this protocol • Ability and willingness to provide written informed consent and comply with the requirements of Part 2 (SM) of the OLE-SM protocol All patients must have completed the 12-week safety follow-up prior to entering Part 2 (SM).
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: Part 1 (OLE) • Patients who leave Study GA29144 before Week 10 • Patients who do not perform the Week 14 visit in Study GA29144 , except for those escaping between Weeks 10 and 14 for disease worsening • Patients who discontinue study drug in the Induction Phase of Study GA29144, except for those escaping between Weeks 10 and 14 due to disease worsening • Patients who received rescue therapy in the absence of disease worsening during the Induction Phase of Study GA29144 • Patients who received rescue therapy in the absence of clinical relapse during the Maintenance Phase of Study GA29144 will not be eligible for Part 1 (OLE) until completing the Week 74 visit in Study GA29144 • Patients who received medications that are prohibited in conjunction with etrolizumab (see protocol) • Patients participating at U.S investigational sites who require continued use of immunosuppressant therapy beyond a total of 14 weeks of co-administration with study drug in Study GA29144 are ineligible for Part 1 (OLE). • Inability to comply with the study protocol, in the opinion of the investigator • Pregnancy or lactation • Patients who developed an anaphylactic/anaphylactoid or severe allergic reaction to study medication during Study GA29144 • Patients who have an untreated or unresolved serious infection event • Patients who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV during Study GA29144 • Patients who developed life-threatening infections during Study GA29144 • Patients who developed a malignancy (with the exception of non-serious local and resectable basal or squamous cell carcinoma of the skin) or who develop adenocarcinoma in situ (AIS), high-grade squamous intraepithelial lesions (HSIL), or cervical intraepithelial neoplasia (CIN) of Grade > 1 on cervical Pap smear or who develop colonic dysplasia during Study GA29144 • Receipt of the following since commencement of Study GA29144: Any investigational treatment, including investigational vaccines Use of T or B cell depleting agents (e.g., rituximab, alemtuzumab or visilizumab) Use of cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) Use of natalizumab, vedolizumab, or efalizumab Use of TNF antagonists Immunization with a live/attenuated vaccine • In the opinion of the investigator, any new (since enrolling in Study GA29144), significant, uncontrolled comorbidity, such as neurological, cardiac (e.g., moderate to severe heart failure New York Heart Association [NYHA] Class III/IV), pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders (excluding CD) • Any patient who developed PML in Study GA29144 • Any patient with neurological symptoms where suspected PML has not been ruled out Part 2 (SM) • No exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy outcome measures for this study are as follows: • CDAI remission assessed at 12-week intervals during Part 1 (OLE) • PRO2 remission assessed at 12-week intervals during Part 1 (OLE) The safety outcome measures for Part 1 of this study are as follows: • Incidence and severity of adverse events • Incidence of serious adverse events • Incidence, rate per subject-year, and severity of infection-related adverse events • Incidence of serious infection-related adverse events • Incidence and severity of injection-site reactions • Incidence of adverse events leading to etrolizumab discontinuation • Incidence of laboratory abnormalities • Incidence and rate per subject-year of malignancies • Incidence of ATAs to etrolizumab • Incidence and severity of hypersensitivity reactions The safety outcome measure for Part 2 of this study is as follows: • Incidence of suspected or confirmed PML events | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Korea (the Republic of), Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States of America
Outcome results
None listed