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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 24, 2006 | ||||
| Last Updated Date | March 26, 2009 | ||||
| Start Date ICMJE | February 2006 | ||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary endpoint is the proportion of subjects who achieve >= 75% improvement in the psoriasis area-and-severity index from baseline at Week 12. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00307437 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Major secondary endpoints are the proportions of subjects with clear or minimal disease at Week 12 by Physician Global Assessment, the improvement in the Dermatology Life Quality Index, and the evaluation of dosing interval adjustment. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of the Safety and Efficacy of CNTO 1275 in Subjects With Moderate to Severe Psoriasis | ||||
| Official Title ICMJE | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis. | ||||
| Brief Summary | The primary objective of this study is to evaluate the efficacy and safety of CNTO 1275 in the treatment of subjects with moderate to severe plaque psoriasis. |
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| Detailed Description | Although numerous therapeutic options exist for the treatment of psoriasis, there is still a significant unmet medical need due to the limited effectiveness and/or significant side effect profile of current treatment options. Preclinical studies and early phase clinical studies suggest that interleukins-12 and -23, two molecules that are part of the communication network in the immune system, may play an important role in psoriasis. CNTO 1275 is a monoclonal antibody directed against interleukins -12 and 23. This is a randomized, double blind, parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The hypothesis is that CNTO 1275 will be more effective in treatment of psoriasis than placebo, that the improvement in psoriasis will result in an improved quality of life for treated patients and that CNTO 1275 will be generally well tolerated. Patients will receive CNTO 1275, 45 or 90 mg, or placebo administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 52. For subjects who partially respond to the starting regimen, the dosing interval may be adjusted to every 8 weeks. Patients will enter long term extension portion of the study at week 52 during which subjects will continue to receive treatment with CNTO 1275 and will be followed for a total of up to 264 weeks from the initial (week 0) administration of study agent. The dose of CNTO 1275 will be 45 or 90 mg or placebo administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter. For subjects who partially respond to the starting regimen, the dosing interval may be adjusted to every 8 weeks. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Psoriasis | ||||
| Intervention ICMJE | Drug: CNTO 1275 | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeilding N, Guzzo C, Hsu MC, Wang Y, Li S, Dooley LT, Reich K; PHOENIX 2 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008 May 17;371(9625):1675-84. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1200 | ||||
| Completion Date | |||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00307437 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CR006325 | ||||
| Study Sponsor ICMJE | Centocor, Inc. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Centocor, Inc. | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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