Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
Patients aged <18 years of age
Patients who cannot give informed consent,
Pregnant patients or those who are breastfeeding will be deemed ineligible.
Prior treatment with any anti-TNF agent
Contra-indication to use of GLM (Hypersensitivity to the active substance or to any of the excipients; Active tuberculosis (TB), acute or chronic Hepatitis B infection or other severe infections such as sepsis and/or opportunistic infections including HIV infection; Moderate or severe heart failure (NYHA class III/IV)
Have symptoms or signs suggestive of current active or latent TB upon medical history, physical examination and/or chest radiograph, or positive Mycobacterium tuberculosis antigen-specific interferon-gamma release assay (IGRA)
Patients with a history of, or at imminent risk for, colectomy; who required gastrointestinal surgery within 2 months before screening;
History of colonic mucosal dysplasia or adenomatous colonic polyps that were not removed
Screening stool study positive for enteric pathogens or Clostridium difficile toxin.
Oral corticosteroids at a dose >40 mg prednisone or its equivalent per day; receipt of cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks before the first study agent injection; or use of an investigational agent within 5 half-lives of that agent before the first study agent injection.
Patients in recent receipt of live vaccinations within 4 weeks prior to enrolment

NCT02687724_exc_T2
Person
aged
NCT02687724_exc_T3
Value
<18 years of age
NCT02687724_exc_T6
Drug
anti-TNF agent
NCT02687724_exc_T7
Procedure
treatment
NCT02687724_exc_T8
Temporal
Prior
NCT02687724_exc_T9
Condition
Contra-indication
NCT02687724_exc_T10
Drug
GLM
NCT02687724_exc_T11
Condition
Hypersensitivity
NCT02687724_exc_T12
Drug
active substance
NCT02687724_exc_T13
Drug
excipients
NCT02687724_exc_T14
Scope
active substance or to any of the excipients
NCT02687724_exc_T15
Condition
tuberculosis (TB)
NCT02687724_exc_T16
Temporal
Active
NCT02687724_exc_T17
Qualifier
acute
NCT02687724_exc_T18
Qualifier
chronic
NCT02687724_exc_T19
Condition
Hepatitis B infection
NCT02687724_exc_T20
Scope
acute or chronic
NCT02687724_exc_T21
Condition
severe infections
NCT02687724_exc_T22
Condition
sepsis
NCT02687724_exc_T23
Condition
opportunistic infections
NCT02687724_exc_T24
Condition
HIV infection
NCT02687724_exc_T25
Qualifier
Moderate
NCT02687724_exc_T26
Qualifier
severe
NCT02687724_exc_T27
Condition
heart failure
NCT02687724_exc_T28
Measurement
NYHA
NCT02687724_exc_T29
Value
class III/IV
NCT02687724_exc_T30
Scope
Moderate or severe
NCT02687724_exc_T31
Scope
Hypersensitivity to the active substance or to any of the excipients; Active tuberculosis (TB), acute or chronic Hepatitis B infection or other severe infections such as sepsis and/or opportunistic infections including HIV infection; Moderate or severe heart failure (NYHA class III/IV
NCT02687724_exc_T32
Scope
Contra-indication to use of GLM
NCT02687724_exc_T33
Qualifier
latent
NCT02687724_exc_T34
Qualifier
active
NCT02687724_exc_T35
Temporal
current
NCT02687724_exc_T36
Condition
TB
NCT02687724_exc_T37
Scope
current active or laten
NCT02687724_exc_T38
Observation
medical history
NCT02687724_exc_T39
Procedure
physical examination
NCT02687724_exc_T40
Procedure
chest radiograph
NCT02687724_exc_T41
Measurement
Mycobacterium tuberculosis antigen-specific interferon-gamma release assay (IGRA)
NCT02687724_exc_T42
Value
positive
NCT02687724_exc_T43
Scope
medical history, physical examination and/or chest radiograph
NCT02687724_exc_T44
Procedure
gastrointestinal surgery
NCT02687724_exc_T45
Temporal
within 2 months before screening
NCT02687724_exc_T46
Procedure
colectomy
NCT02687724_exc_T47
Mood
imminent risk for
NCT02687724_exc_T48
Observation
history of
NCT02687724_exc_T49
Scope
history of, or at imminent risk for
NCT02687724_exc_T50
Condition
colonic mucosal dysplasia
NCT02687724_exc_T51
Condition
adenomatous colonic polyps
NCT02687724_exc_T52
Procedure
removed
NCT02687724_exc_T53
Negation
not
NCT02687724_exc_T54
Procedure
stool study
NCT02687724_exc_T55
Value
positive
NCT02687724_exc_T56
Qualifier
enteric pathogens
NCT02687724_exc_T57
Qualifier
Clostridium difficile toxin
NCT02687724_exc_T58
Scope
enteric pathogens or Clostridium difficile toxin
NCT02687724_exc_T59
Drug
Oral corticosteroids
NCT02687724_exc_T60
Multiplier
dnisone or its eq eceipt
NCT02687724_exc_T61
Drug
cyclosporine
NCT02687724_exc_T62
Drug
tacrolimus
NCT02687724_exc_T63
Drug
sirolimus
NCT02687724_exc_T64
Drug
mycophenolate mofetil
NCT02687724_exc_T65
Temporal
within 8 weeks before the first study agent injection
NCT02687724_exc_T66
Scope
cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil
NCT02687724_exc_T67
Drug
investigational agent
NCT02687724_exc_T68
Temporal
within 5 half-lives
NCT02687724_exc_T69
Temporal
before the first study agent injection
NCT02687724_exc_T70
Drug
live vaccinations
NCT02687724_exc_T71
Temporal
within 4 weeks prior to enrolment