Patients = 18 years of age
Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
Established diagnosis of UC and moderate-to-severe disease activity, defined as a Mayo score of 6-12, with an endoscopic subscore =2.
Patients had an inadequate response to, or had failed to tolerate, 1 or more of the following conventional therapies: oral 5-aminosalicylates, oral corticosteroids, azathioprine (AZA), and/or 6-mercaptopurine (6MP); or corticosteroid dependent (ie, an inability to taper corticosteroids without recurrence of UC symptoms).
Patients concurrently treated with oral 5-aminosalicylates or corticosteroids were to receive a stable dose for at least 2 weeks before baseline, and patients receiving AZA and/or 6MP were to receive a stable dose for at least 4 weeks before baseline. Patients were required to maintain stable doses of their concomitant UC medications during the study.
Female subjects of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 6 months thereafter OR
Surgical sterilized female patients with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy OR
Postmenopausal women with postmenopausal defined as permanent cessation >1 year of previously occurring menses.
Female subjects' serum pregnancy test performed at the screening visit and urine pregnancy test performed at the baseline visit must be negative.
Subjects have following investigations within 1 month prior to enrolment.
Routine bloods including U&E, FBC, LFTs, inflammatory markers (CRP) and albumin will be measured.
Medical history, concomitant medications
Intradermal reaction to Tuberculin (PPD skin test) or Mycobacterium tuberculosis antigenspecific interferon-gamma release assay (IGRA)
TB screening: chest X-Ray unless performed in the last 6 months
Stool examination for enteric pathogens including Clostridium difficile
Inclusion/exclusion criteria
Informed consent
Mayo score (including sigmoidoscopy unless performed in previous 3 months)
Patient's weight and height and abdominal circumference

NCT02687724_inc_T1
Value
= 18 years
NCT02687724_inc_T2
Person
age
NCT02687724_inc_T4
Condition
UC
NCT02687724_inc_T5
Qualifier
moderate-to-severe
NCT02687724_inc_T6
Measurement
Mayo score
NCT02687724_inc_T7
Value
6-12
NCT02687724_inc_T8
Measurement
endoscopic subscore
NCT02687724_inc_T9
Value
=2
NCT02687724_inc_T10
Condition
inadequate response
NCT02687724_inc_T11
Condition
failed to tolerate
NCT02687724_inc_T12
Multiplier
1 or more
NCT02687724_inc_T13
Drug
oral 5-aminosalicylates
NCT02687724_inc_T14
Drug
oral corticosteroids
NCT02687724_inc_T15
Drug
azathioprine (AZA)
NCT02687724_inc_T16
Drug
6-mercaptopurine (6MP)
NCT02687724_inc_T17
Drug
corticosteroid
NCT02687724_inc_T18
Condition
dependent
NCT02687724_inc_T20
Scope
oral 5-aminosalicylates, oral corticosteroids, azathioprine (AZA), and/or 6-mercaptopurine (6MP)
NCT02687724_inc_T21
Scope
inadequate response to, or had failed to tolerate
NCT02687724_inc_T22
Drug
oral 5-aminosalicylates
NCT02687724_inc_T24
Drug
corticosteroids
NCT02687724_inc_T25
Qualifier
stable dose
NCT02687724_inc_T26
Temporal
for at least 2 weeks before baseline
NCT02687724_inc_T27
Scope
oral 5-aminosalicylates or corticosteroids
NCT02687724_inc_T28
Drug
AZA
NCT02687724_inc_T29
Drug
6MP
NCT02687724_inc_T23
Qualifier
stable dose
NCT02687724_inc_T30
Temporal
for at least 4 weeks before baseline
NCT02687724_inc_T31
Scope
AZA and/or 6MP
NCT02687724_inc_T32
Procedure
treated
NCT02687724_inc_T33
Scope
oral 5-aminosalicylates or corticosteroids were to receive a stable dose for at least 2 weeks before baseline, and patients receiving AZA and/or 6MP were to receive a stable dose for at least 4 weeks before baseline
NCT02687724_inc_T40
Procedure
Routine bloods
NCT02687724_inc_T41
Procedure
U&E
NCT02687724_inc_T42
Procedure
FBC
NCT02687724_inc_T43
Procedure
LFTs
NCT02687724_inc_T44
Procedure
inflammatory markers (CRP)
NCT02687724_inc_T45
Procedure
albumin
NCT02687724_inc_T46
Scope
U&E, FBC, LFTs, inflammatory markers (CRP) and albumin
NCT02687724_inc_T48
Procedure
Intradermal reaction to Tuberculin (PPD skin test)
NCT02687724_inc_T49
Procedure
Mycobacterium tuberculosis antigenspecific interferon-gamma release assay (IGRA)
NCT02687724_inc_T50
Temporal
within 1 month prior to enrolment
NCT02687724_inc_T51
Procedure
chest X-Ray
NCT02687724_inc_T52
Procedure
TB screening
NCT02687724_inc_T53
Procedure
Stool examination
NCT02687724_inc_T54
Qualifier
for enteric pathogens including Clostridium difficile
NCT02687724_inc_T57
Procedure
Mayo score
NCT02687724_inc_T58
Procedure
sigmoidoscopy
NCT02687724_inc_T59
Procedure
abdominal circumference
NCT02687724_inc_T60
Procedure
height
NCT02687724_inc_T61
Procedure
weight