Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2010-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Laquinimod
Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts)
Laquinimod
Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment
Placebo
Matching placebo
placebo
Matching placebo for 8 weeks of treatment
Interventions
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Laquinimod
Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment
placebo
Matching placebo for 8 weeks of treatment
Eligibility Criteria
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Inclusion Criteria
2. Moderate to severe Crohn's disease patients as determined by the CDAI score
Exclusion Criteria
2. Subjects with clinically significant GI obstructive symptoms
3. Subjects with a clinically significant or unstable medical or surgical condition
4. Subjects with unstable doses of standard of care medications (5-ASA, antibiotics, oral corticosteroids, immunosuppressants )
5. Women who are pregnant or nursing or who intend to be during the study period.
6. Women of child-bearing potential who do not practice an acceptable method of birth control
18 Years
75 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Geert D'Haens, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Imelda General Hospital
Locations
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Teva Investigational Site 3711
Bonheiden, , Belgium
Teva Investigational Site 3712
Leuven, , Belgium
Teva Investigational Site 3713
Roeselare, , Belgium
Teva Investigational Site 5351
Amiens, , France
Teva Investigational Site 5352
Clichy, , France
Teva Investigational Site 5353
La Tronche, , France
Teva Investigational Site 5350
Lille, , France
Teva Investigational Site 5354
Nice, , France
Teva Investigational Site 5355
Paris, , France
Teva Investigational Site 8046
Jerusalem, IL, Israel
Teva Investigational Site 8047
Petah Tikva, IL, Israel
Teva Investigational Site 8050
Ramat Gan, IL, Israel
Teva Investigational Site 8051
Rehovot, IL, Israel
Teva Investigational Site 8049
Tel Aviv, IL, Israel
Teva Investigational Site 8048
Haifa, , Israel
Teva Investigational Site 3069
Roma, , Italy
Teva Investigational Site 3070
Roma, , Italy
Teva Investigational Site 3072
San Donato Milanese (MI), , Italy
Teva Investigational Site 3819
Amsterdam, , Netherlands
Teva Investigational Site 3820
Rotterdam, , Netherlands
Teva Investigational Site 5361
Krakow, , Poland
Teva Investigational Site 5360
Warsaw, , Poland
Teva Investigational Site 5362
Wroclaw, , Poland
Teva Investigational Site 5363
Wroclaw, , Poland
Teva Investigational Site 9009
Claremont, Cape Town, , South Africa
Teva Investigational Site 9017
Overport, Durban, , South Africa
Teva Investigational Site 9013
Panorama, Cape Town, , South Africa
Teva Investigational Site 3158
Barcelona, , Spain
Teva Investigational Site 3164
Córdoba, , Spain
Teva Investigational Site 3160
Madrid, , Spain
Teva Investigational Site 3428
Bristol, , United Kingdom
Teva Investigational Site 3430
Coventry, , United Kingdom
Teva Investigational Site 3429
Liverpool, , United Kingdom
Teva Investigational Site 3432
London, , United Kingdom
Countries
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References
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D'Haens G, Sandborn WJ, Colombel JF, Rutgeerts P, Brown K, Barkay H, Sakov A, Haviv A, Feagan BG; Laquinimod for Crohn's Disease Investigators. A phase II study of laquinimod in Crohn's disease. Gut. 2015 Aug;64(8):1227-35. doi: 10.1136/gutjnl-2014-307118. Epub 2014 Oct 3.
Other Identifiers
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CD-LAQ-201
Identifier Type: -
Identifier Source: org_study_id
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