Phase 3
Completed N=903
An Efficacy and Safety Study of CNTO 1275 Compared to Etanercept in Patients With Plaque Psoriasis
Source: ClinicalTrials.gov NCT00454584 ↗Enrolled (actual)
903
Serious AEs
3.1%
Results posted
Nov 2012
Primary outcomePrimary: Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 — 197; 141; 256 Participants — p=<0.001
Summary
The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in patients with moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 |
197; 141; 256 | <0.001 sig |
| SECONDARY Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12 |
170; 136; 245 | <0.001 sig |
| SECONDARY Number of Participants Achieving a Greater Than or Equal to 90 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 90) Score at Week 12 |
80; 76; 155 | <0.001 sig |
| SECONDARY Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12) |
-0.99; -0.30 | — |
Eligibility Criteria
Inclusion Criteria
- Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the study
- Have plaque-type psoriasis covering at least 10 percentage of total body surface area
- Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater and a Physician's Global Assessment (PGA) score of 3 or greater at the time of the first administration of study drug
- Must be suitable for phototherapy or systemic treatment for psoriasis
- Have failed to respond to or have condition which prevents use of cyclosporine, methotrexate (MTX) or psoralen plus ultraviolet light A (PUVA)
Exclusion Criteria
- Currently have nonplaque forms of psoriasis
- Have current drug-induced psoriasis
- Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or IL-23 (Interleukins are the substance produced by body in immunological disease like psoriasis)
- Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PASI evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25 dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of the first administration of study agent
- Have used a biologic within the previous 3 months
Data sourced from ClinicalTrials.gov (NCT00454584). 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.