PsoriasisPhase 3NCT00454584
An Efficacy and Safety Study of CNTO 1275 Compared to Etanercept in Patients With Plaque Psoriasis
A Phase 3 study testing CNTO 1275 45 mg, CNTO 1275 90 mg and Etanercept 50 mg in people with Psoriasis, run by Centocor, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- CNTO 1275 45 mg, CNTO 1275 90 mg and Etanercept 50 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 903 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Jan 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: A Phase 3, Multicenter, Randomized Study Comparing CNTO 1275 and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis
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.
- Conditions
- Psoriasis
- Being tested
- CNTO 1275 45 mg, CNTO 1275 90 mg, Etanercept 50 mg
- Keywords
- Psoriasis, CNTO 1275, Etanercept, Immune diorder, Skin disorder
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 1275 45 mgDrug
Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous
CNTO 1275 90 mgDrug
Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous
Etanercept 50 mgDrug
Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Etanercept 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (3)
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).
Measured: 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
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).
Measured: Baseline and Week 12
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454584
- Sponsor's protocol ID
- CR013015
- Other IDs
- C0743T12, 2006-003444-30
- Status last verified
- Oct 2012
- First submitted
- 28 Mar 2007
- Last updated
- 21 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 30739254Griffiths 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized Study Comparing CNTO 1275 and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00454584
- Acronym / sponsor ID
- CR013015
- Conditions
- Psoriasis
- Keywords
- Psoriasis, CNTO 1275, Etanercept, Immune diorder, Skin disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 30 Mar 2007 (estimated)
- Results
- Posted 21 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CNTO 1275 45 mg | Experimental | Drug: CNTO 1275 45 mgPatients 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. |
| CNTO 1275 90 mg | Experimental | Drug: CNTO 1275 90 mgPatients 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. |
| Etanercept 50 mg | Active comparator | Drug: Etanercept 50 mgPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNTO 1275 45 mgType=exact number, number=45, unit=mg, form=injection, route=subcutaneous | Drug | CNTO 1275 45 mg |
| CNTO 1275 90 mgType=exact number, number=90, unit=mg, form=injection, route=subcutaneous | Drug | CNTO 1275 90 mg |
| Etanercept 50 mgType=exact number, number=50, unit=mg, form=injection, route=subcutaneous | Drug | Etanercept 50 mg |
Primary outcome
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
Time frame: Baseline and 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.
3 secondary outcomes
Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12
Time frame: 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
Time frame: Baseline and Week 12
Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30739254Ghosh 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.
- Derived from this study: PubMed 20071701Griffiths 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.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CNTO 1275 45 mg, CNTO 1275 90 mg and Etanercept 50 mg in people with Psoriasis, run by Centocor, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00454584, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2012.