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CompletedNCT00454584Updated Nov 21, 2012Results posted

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

A Phase 3 interventional study of CNTO 1275 45 mg and CNTO 1275 90 mg in Psoriasis, sponsored by Centocor, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-21.

Sponsored by Centocor, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
903
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psoriasis

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Keywords

  • Psoriasis
  • CNTO 1275
  • Etanercept
  • Immune diorder
  • Skin disorder
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 903 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Centocor, Inc. is the lead sponsor of 73 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
903 participants (actual)

Study arms

  • Experimental
    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.

    Drug: CNTO 1275 45 mg

  • Experimental
    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.

    Drug: CNTO 1275 90 mg

  • Active comparator
    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.

    Drug: Etanercept 50 mg

Interventions

  • DrugCNTO 1275 45 mg

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

  • DrugCNTO 1275 90 mg

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

  • DrugEtanercept 50 mg

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

06

What researchers measure

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.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. 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).

    Time frame: Week 12

  2. 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).

    Time frame: Baseline and Week 12

  3. 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).

    Time frame: 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.

07

Results

Posted Nov 21, 2012

Participant flow

903 partcipants received either ustekinumab (CNTO 1275) or etanercept at 67 sites in North America and Europe.

Controlled Period
Participant flow — Controlled Period
MilestoneEtanercept (CP)Ustekinumab 45 mg (CP)Ustekinumab 90 mg (CP)Etanercept (After CP)Ustekinumab 45 mg (After CP)Ustekinumab 90 mg (After CP)
Started347209347000
Completed336201342000
Not completed1185000
Withdrew: Adverse event521000
Withdrew: Lost to follow-up122000
Withdrew: Other542000
After Controlled Period
Participant flow — After Controlled Period
MilestoneEtanercept (CP)Ustekinumab 45 mg (CP)Ustekinumab 90 mg (CP)Etanercept (After CP)Ustekinumab 45 mg (After CP)Ustekinumab 90 mg (After CP)
Started000336201342
Completed000310189310
Not completed000261232
Withdrew: Adverse event000939
Withdrew: Lack of efficacy000100
Withdrew: Lost to follow-up000246
Withdrew: Other000100
Withdrew: Other00013517

Outcome measures

PrimaryNumber 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.

Time frame:
Baseline and Week 12
Reported as:
Number · Participants
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
ParticipantsGroup I: EtanerceptGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mg
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 12197141256
Statistical analysis
  • Group I: Etanercept vs Group III: Ustekinumab 90 mg · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).
  • Group I: Etanercept vs Group II: Ustekinumab 45 mg · Cochran-Mantel-Haenszel (CMH) chi square · p = 0.012 (To control the overall type I error rate at 0.05 level in the primary endpoint analysis, a step-down test procedure was applied. First, ustekinumab 90 mg and etanercept were compared. Then ustekinumab 45 mg and etanercept would be compared.)The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).
SecondaryNumber 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).

Time frame:
Week 12
Reported as:
Number · Participants
Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12
ParticipantsGroup I: EtanerceptGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mg
Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12170136245
Statistical analysis
  • Group I: Etanercept vs Group III: Ustekinumab 90 mg · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).
  • Group I: Etanercept vs Group II: Ustekinumab 45 mg · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).
SecondaryNumber 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).

Time frame:
Baseline and Week 12
Reported as:
Number · Participants
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
ParticipantsGroup I: EtanerceptGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mg
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 128076155
Statistical analysis
  • Group I: Etanercept vs Group III: Ustekinumab 90 mg · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).
  • Group I: Etanercept vs Group II: Ustekinumab 45 mg · Cochran-Mantel-Haenszel (CMH) chi square · p = <0.001The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).
SecondaryDifference 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).

Time frame:
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.
Reported as:
Mean · Score on a scale
Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12)
Score on a scaleGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mg
Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12)-0.99 ± 3.799-0.30 ± 4.124

Adverse events

Collected over Week 64. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Etanercept (CP)—4/347 (1.2%)154/347 (44.4%)
Ustekinumab 45 mg (CP)—4/209 (1.9%)85/209 (40.7%)
Ustekinumab 90 mg (CP)—4/347 (1.2%)126/347 (36.3%)
Etanercept (After CP)—8/337 (2.4%)60/337 (17.8%)
Etanercept -> Ustekinumab 90 mg (After CP)—10/295 (3.4%)102/295 (34.6%)
Ustekinumab 45 mg (After CP)—13/204 (6.4%)85/204 (41.7%)
Ustekinumab 90 mg (After CP)—22/343 (6.4%)164/343 (47.8%)
Most frequent serious events
Showing 10 of 84
Most frequent serious events
EventEtanercept (CP)Ustekinumab 45 mg (CP)Ustekinumab 90 mg (CP)Etanercept (After CP)Etanercept -> Ustekinumab 90 mg (After CP)Ustekinumab 45 mg (After CP)Ustekinumab 90 mg (After CP)
Spinal column stenosisMusculoskeletal and connective tissue disorders0/3470/2090/3470/3372/2950/2040/343
PneumoniaInfections and infestations0/3470/2090/3470/3370/2950/2042/343
SepsisInfections and infestations0/3470/2090/3470/3370/2950/2042/343
HypertensionVascular disorders0/3471/2090/3470/3370/2950/2042/343
AnaemiaBlood and lymphatic system disorders0/3470/2090/3470/3370/2951/2040/343
Myocardial infarctionCardiac disorders0/3470/2091/3470/3371/2951/2041/343
Diverticulitis intestinal haemorrhagicGastrointestinal disorders0/3470/2090/3470/3370/2951/2040/343
Mallory-Weiss syndromeGastrointestinal disorders0/3470/2090/3470/3370/2951/2040/343
Haematoma infectionInfections and infestations0/3470/2090/3470/3370/2951/2040/343
Gun shot woundInjury, poisoning and procedural complications0/3470/2090/3470/3370/2951/2040/343
Most frequent other events
Showing 10 of 12
Most frequent other events
EventEtanercept (CP)Ustekinumab 45 mg (CP)Ustekinumab 90 mg (CP)Etanercept (After CP)Etanercept -> Ustekinumab 90 mg (After CP)Ustekinumab 45 mg (After CP)Ustekinumab 90 mg (After CP)
NasopharyngitisInfections and infestations30/34721/20934/34725/33738/29534/20463/343
Upper respiratory tract infectionInfections and infestations20/34713/20922/34722/33735/29529/20455/343
Injection site erythemaGeneral disorders53/3472/2093/3470/3372/2950/2045/343
HeadacheNervous system disorders38/34731/20942/3475/3379/2958/20421/343
Injection site haematomaGeneral disorders25/3471/2096/3470/3370/2950/2042/343
Injection site swellingGeneral disorders25/3473/2091/3470/3370/2950/2041/343
Back painMusculoskeletal and connective tissue disorders7/34714/20915/3473/3373/2955/20422/343
PruritusSkin and subcutaneous tissue disorders14/34712/20916/3475/3376/2953/2046/343
FatigueGeneral disorders13/3478/20919/3470/3371/2955/2047/343
Oropharyngeal painRespiratory, thoracic and mediastinal disorders14/3475/20914/3472/3373/29511/2046/343

Baseline characteristics

Age Continuous
Age Continuous(years)Group I: EtanerceptGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mgTotal
Mean45.7 ± 13.4045.1 ± 12.5644.8 ± 12.2945.2 ± 12.78
Sex: Female, Male
Sex: Female, Male(Participants)Group I: EtanerceptGroup II: Ustekinumab 45 mgGroup III: Ustekinumab 90 mgTotal
Female10176113290
Male246133234613
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. Erratum In: Drug Saf. 2019 Jun;42(6):809. doi: 10.1007/s40264-019-00816-3. PubMed 30739254 ↗
  • 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. PubMed 20071701 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00454584
Lead sponsor
Centocor, Inc.
Responsible party
Sponsor
First posted
Mar 30, 2007
Start date
Mar 2007
Primary completion
Jan 2008
Completion
Jan 2009
Results posted
Nov 21, 2012
Last update
Nov 21, 2012

Study contacts

Centocor, Inc. Clinical Trial
study director · Centocor, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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