Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01336465
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE April 14, 2011
First Posted Date  ICMJE April 18, 2011
Last Update Posted Date August 12, 2016
Study Start Date  ICMJE September 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2011)
Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point [ Time Frame: Week 10 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
Clinical remission defined as a Mayo Clinic Score (MCS) ≤ 2 with no individual subscore exceeding 1 point [ Time Frame: Week 10 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2011)
  • 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 [ Time Frame: Week 6 and Week 10 ]
  • Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point [ Time Frame: Week 6 ]
  • Proportion of patients with endoscopic score and rectal bleeding score of 0 [ Time Frame: Week 6 and Week 10 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
  • 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 [ Time Frame: Week 6 and Week 10 ]
  • Clinical remission defined by a MCS ≤ 2 with no individual subscore exceeding 1 point [ Time Frame: Week 6 ]
  • Proportion of patients with endoscopic score and rectal bleeding score of 0 [ Time Frame: Week 6 and Week 10 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: placebo
    Repeating subcutaneous injection
  • Drug: rhuMAb Beta7
    Repeating subcutaneous injection
Study Arms  ICMJE
  • Experimental: rhuMAb Beta7
    Intervention: Drug: rhuMAb Beta7
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Vermeire S, O'Byrne S, Keir M, Williams M, Lu TT, Mansfield JC, Lamb CA, Feagan BG, Panes J, Salas A, Baumgart DC, Schreiber S, Dotan I, Sandborn WJ, Tew GW, Luca D, Tang MT, Diehl L, Eastham-Anderson J, De Hertogh G, Perrier C, Egen JG, Kirby JA, van Assche G, Rutgeerts P. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet. 2014 Jul 26;384(9940):309-18. doi: 10.1016/S0140-6736(14)60661-9. Epub 2014 May 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2013)
124
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2011)
120
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of moderate to severe ulcerative colitis outpatient
  • Disease duration at time of screening of >/= 12 weeks

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czech Republic,   Germany,   Hungary,   Israel,   New Zealand,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01336465
Other Study ID Numbers  ICMJE ABS4986g
GP27778 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sharon O'Byrne, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP