N/A
Completed N=660
Assessment of Long-Term Infliximab for Psoriasis (P05319)
Source: ClinicalTrials.gov NCT00779675 ↗Enrolled (actual)
660
Serious AEs
8.5%
Results posted
Oct 2012
Primary outcomePrimary: Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50 — 296 Participants
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 practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population, prescribed in a regimen in accordance with the product monograph (PM) for Canada, the approved summary sheet of product characteristics (SPC) for countries in the European Union (EU), or per label according to local guidelines for all other participating countries.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50 |
296 | — |
| SECONDARY Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14 |
104 | — |
| SECONDARY Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14 |
205; 152 | — |
| SECONDARY Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14 |
292; 238; 170 | — |
| SECONDARY Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period |
66 | — |
| SECONDARY Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period |
81; 107; 122 | — |
| SECONDARY Change From Baseline in Mean PASI Score |
-17.3; -18.0; -18.4; -17.8; -17.5; -17.3 | — |
| SECONDARY Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase |
77; 101 | — |
| SECONDARY Change From Baseline in Mean Dermatology Life Quality Index (DLQI) |
9.8; 9.0; 9.7; 9.4 | — |
| SECONDARY Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase |
77; 102; 51; 16; 51; 75 | — |
| SECONDARY Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98 |
129; 112; 82; 35 | — |
| SECONDARY Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age |
264; 32 | — |
| SECONDARY Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender |
199; 97 | — |
| SECONDARY Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race |
235; 61 | — |
| SECONDARY Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline |
171; 125 | — |
| SECONDARY Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline |
77; 219 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT00779675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.