Phase 4
Completed N=38
A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133)
Source: ClinicalTrials.gov NCT00686595 ↗Enrolled (actual)
38
Serious AEs
18.4%
Results posted
Feb 2011
Primary outcomePrimary: Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10 — 71 Percentage of participants
Summary
This study will evaluate the efficacy, tolerability, and effect on the quality of life of infliximab in adults with moderate-to-severe psoriasis who are resistant to etanercept after 12 weeks of treatment or have failed 24 weeks of treatment with etanercept. Infliximab will be administered as an intravenous infusion of 5 mg/kg at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10 |
71 | — |
| SECONDARY PASI 75 Response Rate at Week 18 |
94 | — |
| SECONDARY PASI 75 Response Rate at Week 24 |
74 | — |
| SECONDARY PASI 50 Response Rate at Week 10 |
91 | — |
| SECONDARY PASI 50 Response Rate at Week 18 |
97 | — |
| SECONDARY PASI 50 Response Rate at Week 24 |
89 | — |
| SECONDARY PASI 90 Response Rate at Week 10 |
37 | — |
| SECONDARY PASI 90 Response Rate at Week 18 |
56 | — |
| SECONDARY PASI 90 Response Rate at Week 24 |
54 | — |
| SECONDARY PASI 100 Response Rate at Week 10 |
17 | — |
| SECONDARY PASI 100 Response Rate at Week 18 |
31 | — |
| SECONDARY PASI 100 Response Rate at Week 24 |
40 | — |
| SECONDARY Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18 |
89 | — |
| SECONDARY Percent Reduction in SAPASI at Week 24 |
82 | — |
| SECONDARY Percent Reduction in Affected Body Surface Area (BSA) at Week 18 |
82 | — |
| SECONDARY Percent Reduction in Affected BSA at Week 24 |
72 | — |
| SECONDARY Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18 |
81 | — |
| SECONDARY Percent Reduction in VAS Referred Itch at Week 24 |
72 | — |
| SECONDARY Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18 |
77 | — |
| SECONDARY Percent Reduction in DLQI Total Score at Week 24 |
68 | — |
| SECONDARY Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18 |
42; 39; 39 | — |
| SECONDARY Percent Reduction in SKINDEX-29 Scores at Week 24 |
40; 32; 31 | — |
Eligibility Criteria
Inclusion Criteria
- >=18 to 75 years of age at Screening, either sex, and any race.
- Diagnosis of moderate-to-severe plaque psoriasis >6 months prior to Screening.
- Resistant (after 12 weeks) or failed 24 weeks of etanercept treatment.
- Not reached PASI 75 at Screening Visit after 24 weeks of etanercept treatment or resistant to etanercept.
- Agree to avoid prolonged sun exposure or artificial ultraviolet light sources during study.
- Satisfy requirements of Screening and tuberculosis (TB) test as specified in protocol.
- Chest x-ray at Visit 1 or within 3 months prior to Visit 1 with no evidence of malignancy, infection, or fibrosis.
- Laboratory tests must be within protocol-specified parameters.
- Free of any clinically significant disease that would interfere with study evaluations.
- Willing to participate and adhere to study procedures by signing written informed consent.
- Women of childbearing potential and all men must be using adequate birth control measures and continue to do so until 6 months after receiving last dose of study medication.
- Females of childbearing potential must have negative serum pregnancy test at Visit 1 and negative urine pregnancy test at Visit 2.
Exclusion Criteria
- Achieve PASI 75 or have BSA 3 months prior to Visit 1).
- History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location.
- Malignancy within previous 5 years (exception - basal cell carcinoma of skin that has been treated with no evidence of recurrence).
- Unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
- Have had substance abuse (drug or alcohol) problem within previous 3 years.
- History of any clinically significant adverse reactions (including allergic reactions) to paracetamol/acetaminophen or histamine H1 receptor antagonist.
- In a situation or have a condition that, in opinion of investigator, may interfere with optimal participation in study.
- Used investigational drugs within 4 weeks of Screening.
- Participating in any other clinical study.
- Staff personnel directly involved with this study.
- Family members of investigational study staff.
Data sourced from ClinicalTrials.gov (NCT00686595). 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.