Phase 3
Completed N=215
PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept
Source: ClinicalTrials.gov NCT00527072 ↗Enrolled (actual)
215
Serious AEs
3.7%
Results posted
Jun 2010
Primary outcomePrimary: Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0) — 138 participants — p=0.05
Summary
The purpose of this study is to test the safety and effectiveness of infliximab in patients with plaque psoriasis who have been receiving the drug etanercept for treatment of their plaque psoriasis for at least four months, without enough improvement in their psoriasis symptoms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0) |
138 | 0.05 |
| SECONDARY Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10 |
167 | 0.05 |
| SECONDARY Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26 |
135 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Have plaque psoriasis despite at least 4 months of treatment with etanercept per current product labeling
- Have psoriatic target lesions that have a PGA score greater than 1 (minimal) at screening
- If receiving methotrexate at screening, must have received methotrexate for at least 3 months and at a stable dose of <= 25 mg/week for at least 4 weeks prior to screening
- If receiving cyclosporine at screening, must have received cyclosporine at a stable dose of <= 5 mg/kg daily for at least 4 weeks prior to screening.
Exclusion Criteria
- Have already received infliximab or adalimumab
- Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product
- Have a history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening
- Have a concomitant diagnosis or any history of Congestive Heart Failure
- Are pregnant, nursing, or planning pregnancy
- Have used systemic corticosteroids within the 4 weeks prior to screening
- Have used topical corticosteroids or have initiated treatment with other topical therapies that could affect psoriasis or Psoriasis Area and Severity Index (PASI) evaluation (e.g., tar, anthralin, calcipotriene, tazarotene, methoxsalen) within 2 weeks prior to screening
- Have used new systemic agents/treatments, other than methotrexate, that can affect psoriasis including, but not limited to, immunosuppressants and/or psoralen plus ultraviolet A light (PUVA) within the 4 weeks prior to screening.
Data sourced from ClinicalTrials.gov (NCT00527072). 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.