Clinical trial NCT00430898: Basiliximab in Moderate to Severe Ulcerative Colitis
Official title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis basiliximab
Lead sponsor: Cerimon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-02-02
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.


Eligibility criteria: Inclusion Criteria:

In addition to others,

* Men or women age 18-75
* Diagnosis of ulcerative colitis confirmed through screening endoscopy.
* Extent of disease must involve at least the left colon
* Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present.
* Inadequate response despite treatment with prednisone 40 - 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry

Exclusion Criteria:

In addition to other protocol-defined conditions,

* Pregnancy
* Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin
* Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings
* Severely ill patients as evidenced by protocol-defined systemic criteria
* Chest radiograph abnormalities consistent with an infectious process
* History of colonic dysplasia
* HIV infection
* Known viral Hepatitis B or C infection
* History of or exposure to tuberculosis within 6 months before study entry

Primary outcomes:
measure: Change in Mayo Score, Safety
timeFrame: At week 8
Secondary outcomes:
measure: Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use
timeFrame: at week 4 and 8
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Roseville
country: United States
state: California
city: Golden
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Urbana
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Topeka
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Troy
country: United States
state: Michigan
city: Egg Harbor Twp
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: New York
country: United States
state: New York
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Sewickley
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Leuven
country: Belgium
city: Mlada Boleslav
country: Czech Republic
city: Praha 10
country: Czech Republic
city: Praha 4
country: Czech Republic
city: Praha 7
country: Czech Republic
city: Tabor
country: Czech Republic
city: Usti nad Orlici
country: Czech Republic
city: Bangalore
country: India
city: Cochin
country: India
city: Hyderabaad
country: India
city: Kolkata
country: India
city: Lucknow
country: India
city: Ludhiana
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: Visakhapatnam
country: India
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Poznan
country: Poland
city: Sopot
country: Poland
city: Sopot
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Nitra
country: Slovakia
city: Nove Mesto nad Vahom
country: Slovakia
city: Presov
country: Slovakia
city: Dnepropetrovsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Bristol
country: United Kingdom
city: Derbyshire
country: United Kingdom
city: London
country: United Kingdom
city: Stoke on Trent
country: United Kingdom
city: Wigan
country: United Kingdom
Study officials:
affiliation: Cerimon Pharmaceuticals
name: Daniel Levitt, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Sands BE, Sandborn WJ, Creed TJ, Dayan CM, Dhanda AD, Van Assche GA, Gregus M, Sood A, Choudhuri G, Stempien MJ, Levitt D, Probert CS. Basiliximab does not increase efficacy of corticosteroids in patients with steroid-refractory ulcerative colitis. Gastroenterology. 2012 Aug;143(2):356-64.e1. doi: 10.1053/j.gastro.2012.04.043. Epub 2012 Apr 28.