Status:
COMPLETED
Assessment of Long-Term Infliximab for Psoriasis (P05319)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in participants with plaque-type psoriasis to assess the clinical response in real-world prac...
Detailed Description
This study will be conducted in two phases: the 50-week treatment period and the 48-week extended treatment period.
Eligibility Criteria
Inclusion
- Participant must have a diagnosis of plaque-type psoriasis
- Participant's physician must have decided, with the subject's consent, to start treatment with infliximab
- Participant must demonstrate willingness to participate in the study and agree with the procedures of the study by signing the written informed consent
- For inclusion into the extended treatment period, participant must have completed 50 weeks of infliximab treatment in the treatment period
- For inclusion into the extended treatment period, participant must be continuing treatment with intravenous infliximab
- For inclusion into the extended treatment period, participant must have an improvement in their PASI score of greater than or equal to 25% at the time of entry into to the extended treatment period
Exclusion
- For the Treatment Period
- Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is eligible for the trial (Inclusion Criteria). The treating physician is expected, as in normal clinical practice, to follow the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications and precautions
- For the Extended Treatment Period
- Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is receiving infliximab treatment in accordance with the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications, precautions, dosing and frequency of administration
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00779675
Start Date
October 1 2008
End Date
August 1 2012
Last Update
November 2 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.