Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315) (DOSE)
Tracking Information
Start Date ICMJE | October 2008 |
---|---|
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: January 29, 2009) | PASI-75 response rate at Week 28. [ Time Frame: At week 28 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00833053 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: January 29, 2009) |
|
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315) |
---|---|
Official Title ICMJE | A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis |
Brief Summary | Patients from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Condition ICMJE | Psoriasis |
Intervention ICMJE |
|
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 200 | ||||
---|---|---|---|---|---|
Estimated Completion Date | December 2011 | ||||
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | Canada, Denmark, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00833053 |
---|---|
Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
Study ID Numbers ICMJE | P05315, EUDRACT: 2008-000454-12 |
Study Sponsor ICMJE | Schering-Plough |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Schering-Plough |
Source: http://clinicaltrials.gov/