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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01336465




Registration number
NCT01336465
Ethics application status
Date submitted
14/04/2011
Date registered
18/04/2011
Date last updated
12/08/2016

Titles & IDs
Public title
Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Scientific title
Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Secondary ID [1] 0 0
GP27778
Secondary ID [2] 0 0
ABS4986g
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - placebo
Treatment: Drugs - rhuMAb Beta7

Experimental: rhuMAb Beta7 -

Placebo Comparator: placebo -


Treatment: Drugs: placebo
Repeating subcutaneous injection

Treatment: Drugs: rhuMAb Beta7
Repeating subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point
Timepoint [1] 0 0
Week 10
Secondary outcome [1] 0 0
Clinical response as defined by at least a 3-point decrease and 30% reduction from baseline in MCS and a >/=1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1
Timepoint [1] 0 0
Week 6 and Week 10
Secondary outcome [2] 0 0
Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point
Timepoint [2] 0 0
Week 6
Secondary outcome [3] 0 0
Proportion of patients with endoscopic score and rectal bleeding score of 0
Timepoint [3] 0 0
Week 6 and Week 10

Eligibility
Key inclusion criteria
- Diagnosis of moderate to severe ulcerative colitis outpatient

- Disease duration at time of screening of >/= 12 weeks
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Extensive colonic resection or subtotal or total colectomy

- Presence of an ileostomy or colostomy

- Moderate to severe anemia

- A history or evidence of colonic mucosal dysplasia

- Pregnant or lactating

- Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary,
renal, hepatic, endocrine, or gastrointestinal (GI) disorders

- Significant screening ECG abnormalities, including evidence of acute myocardial
infarction, complete left bundle branch block, second-degree heart block, or complete
heart block

- Poorly controlled diabetes

- Impaired renal function

- Impaired hepatic function in the absence of a diagnosis of primary sclerosing
cholangitis

- Positive tests for antibodies indicating active or prior infection with HIV or
hepatitis B (HBV) or C (HCV)

- Positive screening test for latent mycobacterium tuberculosis (TB) infection

- Demyelinating disease

- Received any investigational treatment within 12 weeks prior to initiation of study
treatment

- Previous exposure to rhuMAb Beta7

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
ACT,VIC
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Fitzroy
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3181 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
Belgium
State/province [9] 0 0
Bonheiden
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Belgium
State/province [12] 0 0
Liège
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Hradec Kralove
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Nachod
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Ostrava - Poruba
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Zlin
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Hannover
Country [21] 0 0
Germany
State/province [21] 0 0
Kiel
Country [22] 0 0
Germany
State/province [22] 0 0
Minden
Country [23] 0 0
Germany
State/province [23] 0 0
Ulm
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Hungary
State/province [25] 0 0
Gyor
Country [26] 0 0
Hungary
State/province [26] 0 0
Gyöngyös
Country [27] 0 0
Hungary
State/province [27] 0 0
Mosonmagyaróvár
Country [28] 0 0
Israel
State/province [28] 0 0
Beer Sheva
Country [29] 0 0
Israel
State/province [29] 0 0
Haifa
Country [30] 0 0
Israel
State/province [30] 0 0
Jerusalem
Country [31] 0 0
Israel
State/province [31] 0 0
Ramat Gan
Country [32] 0 0
Israel
State/province [32] 0 0
Tel Aviv
Country [33] 0 0
New Zealand
State/province [33] 0 0
Auckland
Country [34] 0 0
New Zealand
State/province [34] 0 0
Christchurch
Country [35] 0 0
New Zealand
State/province [35] 0 0
Dunedin
Country [36] 0 0
New Zealand
State/province [36] 0 0
Takapuna
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Harrow
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to
evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe
ulcerative colitis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01336465
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon O'Byrne, M.D.
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01336465