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Study to Evaluate the Long-term Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

This study is currently recruiting participants.
Verified June 2012 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01461317
First received: October 12, 2011
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g and meet the eligibility criteria for entry in the OLE study.


Condition Intervention Phase
Ulcerative Colitis
 Drug: rhuMAb Beta7
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Rhumab Beta7 in Patients With Moderate to Severe Ulcerative Colitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Incidence of serious adverse events [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinically significant changes in vital signs and safety laboratory measures [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Study discontinuation due to adverse events [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Incidence and nature of injection-site reactions and hypersensitivity [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Incidence of infectious complications [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity as measured by the incidence of anti-therapeutic antibodies (ATAs) [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Clinical signs and symptoms of allergic reaction to rhuMAb Beta7 [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: rhuMAb Beta7
Repeating subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients (placebo or active) who were previously enrolled in the Phase II study (ABS4986g) and fulfill any of the following criteria:

  • Patients who have not obtained a clinical response in the Phase II study (ABS4986g) by Week 10 (the end of the Phase II treatment phase) may enter this OLE trial at any time after Week 10 and up to and including Week 28
  • Patients who have a clinical response in the Phase II study (ABS4986g) at Week 10 but have had a flare of UC between Week 10 and Week 28
  • Ability and willingness to provide written informed consent and comply with the requirements of the OLE protocol
  • Males and females with reproductive potential must be willing to use a highly effective method of contraception, vaginal ring, intrauterine device, physical barrier, or vasectomized partner) from study start to a minimum of 4 months (approximately 5 half lives)

Patients at study sites in the United States must meet the following additional inclusion requirements for OLE study entry:

  • Concomitant immunosuppressive therapy must be discontinued before entry into this OLE study
  • Patients must have tapered completely off oral corticosteroids within 24 weeks of enrollment to this OLE study

Exclusion Criteria:

  • Patients who did not complete through Week 10 of the Phase II study (ABS4986g)
  • Pregnancy or lactation
  • Any new malignancy within the past 6 months
  • Any new (since enrolling in the Phase II study [ABS4986g]), significant, uncontrolled co- morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders
  • Any new clinically significant signs or symptoms of infection as judged by the investigator
  • Any abnormal lab values recorded at the last visit completed in the Phase II study (ABS4986g)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461317

Contacts
Contact: Please reference Study ID Number: GA27927 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 50 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01461317     History of Changes
Other Study ID Numbers: GA27927
Study First Received: October 12, 2011
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013