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

NCT ID: NCT00454584

Last Updated: 2012-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 903 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-01-31

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.

Detailed Description

This is a multicenter, randomized (study medication assigned by chance), active-controlled, parallel, 3-arm study. Patients will be randomly (allocation to treatments available by chance) assigned in 3:5:5 ratio to receive one of three treatments groups. The three treatment groups are: Group 1 - CNTO 1275 45 mg dosing at weeks 0 and 4, Group 2 - CNTO 1275 90 mg dosing at weeks 0 and 4, Group 3 - Etanercept 50 mg two times per week through week 12. The total duration for each participant will be up to 64 weeks (approximately 16 months). The active-controlled portion of the study is from Week 0 to Week 12 during which the efficacy and safety of etanercept and 2 dose levels of CNTO 1275 will be evaluated. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment. Patients will receive 2 subcutaneous injections of CNTO 1275 (either 45 or 90 mg doses) or twice weekly injections of etanercept during the first twelve weeks of the study. Patients may receive two additional doses of CNTO 1275 (either 45 or 90 mg doses) up to week 44.

Conditions

Psoriasis

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CNTO 1275 45 mg

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.

Group Type: EXPERIMENTAL

CNTO 1275 45 mg

Intervention Type: DRUG

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

CNTO 1275 90 mg

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.

Group Type: EXPERIMENTAL

CNTO 1275 90 mg

Intervention Type: DRUG

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

Etanercept 50 mg

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.

Group Type: ACTIVE_COMPARATOR

Etanercept 50 mg

Intervention Type: DRUG

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

Interventions

CNTO 1275 45 mg

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

Intervention Type: DRUG

CNTO 1275 90 mg

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

Intervention Type: DRUG

Etanercept 50 mg

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Countries

Austria; Belgium; Canada; Denmark; Finland; Germany; Netherlands; United Kingdom; United States

References

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.

Reference Type: DERIVED

PMID: 30739254 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20071701 (View on PubMed)

Other Identifiers

C0743T12

Identifier Type: OTHER

Identifier Source: secondary_id

2006-003444-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR013015

Identifier Type: -

Identifier Source: org_study_id