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

Psoriasis Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized Study Comparing CNTO 1275 and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454584
• Other study ID #: CR013015
• Secondary ID: C0743T122006-003
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2007
• Last updated: October 19, 2012
• Start date: March 2007
• Est. completion date: January 2009

Study information

• Verified date: October 2012
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 903
• Est. completion date: January 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• CNTO 1275 45 mg
Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous
• CNTO 1275 90 mg
Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous
• Etanercept 50 mg
Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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	No
Secondary	Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12	Number of participants achieving a physician global assessment (PGA) (0-5) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trial of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).	Week 12	No
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	Number of participants achieving greater than or equal to 90 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 and Week 12	No
Secondary	Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12)	The difference between the PASI score at Week 12 and that achieved after 12 weeks of retreatment. The 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).	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.	No