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| Sponsor: | Abbott |
|---|---|
| Information provided by (Responsible Party): | Abbott |
| ClinicalTrials.gov Identifier: | NCT00570986 |
Purpose
Safety and efficacy of ABT-874 in the treatment of moderate to severe plaque psoriasis two doses of ABT-874 versus placebo
| Condition | Intervention | Phase |
|---|---|---|
|
Plaque Psoriasis |
Drug: Placebo Biological: ABT-874 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
| Enrollment: | 1465 |
| Study Start Date: | December 2007 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Arm #1 is used for entire study. At week 12, arm is rerandomized.
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Drug: Placebo
Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.
Other Name: Placebo
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Active Comparator: 2
Arm #2 is used for entire study. At week 12, arm is rerandomized.
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Biological: ABT-874
200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.
Other Name: ABT-874
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Active Comparator: 3
Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.
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Biological: ABT-874
100mg every 12 weeks.
Other Name: ABT-874
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 117 Study Locations| Study Director: | Joaquin Valdes, MD | Abbott |
More Information
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00570986 History of Changes |
| Other Study ID Numbers: | M06-890 |
| Study First Received: | December 7, 2007 |
| Last Updated: | August 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Plaque Psoriasis |
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |