PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept

NCT00527072 | Completed Phase 3 Results

• 2 other identifiers: CR014500C0168Z04
• Study Type: interventional
• Target: 217
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psoriasis

Keywords

plaque psoriasis; psoriasis; infliximab; remicade; etanercept; enbrel; psunrise; C0168Z04

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0)

  Patients who did not have a PGA score at Week 10 will be treated as not having achieved a PGA score of minimal (1) or clear (0) at Week 10. Specifically, treatment failures prior to Week 10 will be classified as not having a minimal (1) or clear (0).

  Week 10

Secondary Outcomes (2)

• Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10

  Week 10

• Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26

  Week 26

Study Arms (1)

001

EXPERIMENTAL

infliximabOpen-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.

Biological: infliximab

Interventions

infliximab BIOLOGICAL

Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.

001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centocor Ortho Biotech Services, L.L.C.: lead

Related Publications (1)

• Gottlieb AB, Kalb RE, Blauvelt A, Heffernan MP, Sofen HL, Ferris LK, Kerdel FA, Calabro S, Wang J, Kerkmann U, Chevrier M. The efficacy and safety of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept: results of a prospective, multicenter, open-label study. J Am Acad Dermatol. 2012 Oct;67(4):642-50. doi: 10.1016/j.jaad.2011.10.020. Epub 2011 Dec 9.

  PMID: 22153792 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Sr. Director, Clinical Research - Medical Affairs
• Organization: Janssen Biotech, Inc.

215-325-5711

Study Officials

• Centocor Ortho Biotech Services, L.L.C. Clinical Trial

  Centocor Ortho Biotech Services, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 3, 2012
• Results First Posted: June 24, 2010

Record last verified: 2012-08