An Efficacy and Safety Study of CNTO 1275 Compared to Etanercept in Patients With Plaque Psoriasis

NCT00454584 | Completed Phase 3 Results DMC

• 3 other identifiers: CR013015C0743T122006-003444-30
• Study Type: interventional
• Target: 903
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psoriasis

Keywords

Psoriasis; CNTO 1275; Etanercept; Immune diorder; Skin disorder

Outcome Measures

Primary Outcomes (1)

• 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

  Number of participants achieving greater than or equal to 75 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). Baseline visit refers to Week 0.

  Baseline and Week 12

Secondary Outcomes (3)

• Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12

  Week 12

• 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

  Baseline and Week 12

• Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12)

  Up to Week 52. Retreatment may occur anytime between Week 16 and Week 40 depending on time of losing PGA response. Hence end of 12 weeks of retreatment would be between Week 28 and Week 52, inclusive.

Study Arms (3)

CNTO 1275 45 mg

EXPERIMENTAL

Patients will receive CNTO 1275 45 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment.

Drug: CNTO 1275 45 mg

CNTO 1275 90 mg

EXPERIMENTAL

Patients will receive CNTO 1275 90 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on PGA response at Week 12 and initial treatment assignment.

Drug: CNTO 1275 90 mg

Etanercept 50 mg

ACTIVE COMPARATOR

Patients will receive Etanercept 50 mg twice weekly through Week 12. Treatment after Week 12 is dependent on PGA response at Week 12 and initial treatment assignment.

Drug: Etanercept 50 mg

Interventions

CNTO 1275 45 mg DRUG

Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous

CNTO 1275 45 mg

CNTO 1275 90 mg DRUG

Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous

CNTO 1275 90 mg

Etanercept 50 mg DRUG

Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous

Etanercept 50 mg

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centocor, Inc.: lead

Related Publications (2)

• Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.

  PMID: 30739254 DERIVED

• Griffiths CE, Strober BE, van de Kerkhof P, Ho V, Fidelus-Gort R, Yeilding N, Guzzo C, Xia Y, Zhou B, Li S, Dooley LT, Goldstein NH, Menter A; ACCEPT Study Group. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med. 2010 Jan 14;362(2):118-28. doi: 10.1056/NEJMoa0810652.

  PMID: 20071701 DERIVED

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

Ustekinumab; Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Senior Director, Compound Development Team Leader
• Organization: Centocor Research & Development, Inc.

1 215-793-7612

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2007
• First Posted: March 30, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2009
• Last Updated: November 21, 2012
• Results First Posted: November 21, 2012

Record last verified: 2012-10