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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01461317
First received: October 12, 2011
Last updated: September 2, 2014
Last verified: September 2014

October 12, 2011
September 2, 2014
November 2011
February 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01461317 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Long-term Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Rhumab Beta7 in Patients With Moderate to Severe Ulcerative Colitis

This study is an open-label extension (OLE) trial to evaluate the safety and tol erability 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcerative Colitis
Drug: rhuMAb Beta7
Repeating subcutaneous injection
Experimental: A
Intervention: Drug: rhuMAb Beta7
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
116
February 2015
February 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   Germany,   Hungary,   Israel,   New Zealand,   Spain,   United Kingdom
 
NCT01461317
GA27927
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
September 2014

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