CClinicalTrials.gg
CompletedNCT00687401ESAQUALITYUpdated Apr 11, 2017Results posted

A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)

A Phase 3 interventional study of Infliximab in Psoriasis, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-11.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
215
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).

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Conditions studied

  • Psoriasis

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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 215 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

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

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • >=18 to 75 years of age, of either gender, and of any race.
  • Psoriasis covering at least 10% of total body surface area (BSA) and PASI >=12 at Screening and Baseline.
  • Diagnosis of moderate-to-severe psoriasis at least 6 months prior the screening.
  • Eligible to infliximab who have failed at least 1 of the following: corticosteroids, methotrexate (MTX), systemic retinoids, cyclosporine, psoralen-ultraviolet A (PUVA), ultraviolet B (UVB) phototherapy, and/or biologics (etanercept or efalizumab).
  • Eligible according to tuberculosis (TB) eligibility assessment, screening and early detection of reactivation rules.
  • Chest x-ray within 3 months prior to Screening with no evidence of malignancy, infection, or fibrosis.
  • Screening and Baseline tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within protocol-specified parameters.
  • Free of significant disease that could interfere with study evaluations.
  • Willing to give written informed consent and able to adhere to protocol visits and procedures.
  • Women of childbearing potential and all men must be using adequate birth control and must continue to do so for 6 months after receiving the last dose of study medication.
  • Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.

Exclusion criteria

Exclusion Criteria:

  • Standard concomitant psoriasis therapies.
  • Active or latent TB.
  • History of chronic infectious disease, opportunistic infection, or serious infection within 2 months of enrollment.
  • History of lymphoproliferative disease.
  • Malignancy in past 5 years (except treated basal cell carcinoma [BCC]).
  • Treatment with tumor necrosis factor (TNF) antagonists within previous 6 weeks.
  • Current drug-induced psoriasis.
  • Females who are pregnant or nursing and females and males who are planning pregnancy within 6 months from the last infusion of infliximab.
  • Previously treated with infliximab.
  • Concomitant diagnosis of congestive heart failure (CHF) including medically-controlled asymptomatic subjects.
  • History of chronic or recurrent infectious disease.
  • Have or have had a serious infection or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to Screening.
  • Have or have had an opportunistic infection within 6 months prior to Screening.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
215 participants (actual)

Study arms

  • Experimental
    Infliximab 5 mg/kg

    Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6, and 14.

    Biological: Infliximab

Interventions

  • BiologicalInfliximab

    Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).

    Also known as: Remicade, SCH 215596

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What researchers measure

Primary outcomes

  1. Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score

    PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).

    Time frame: 10 weeks

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Results

Posted Dec 24, 2010

Participant flow

Participant flow — Overall Study
MilestoneInfliximab 5 mg/kg
Started159
Completed129
Not completed30
Withdrew: Protocol violation7
Withdrew: Adverse event6
Withdrew: Lack of efficacy6
Withdrew: Withdrawal by subject4
Withdrew: Did not return for visit3
Withdrew: For reasons different from those above4

Outcome measures

PrimaryNumber of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score

PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).

Time frame:
10 weeks
Reported as:
Number · Participants
Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score
ParticipantsIntent to Treat PopulationPer Protocol Population
Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score111111

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Infliximab 5 mg/kg—2/159 (1.3%)16/159 (10.1%)
Most frequent serious events
Most frequent serious events
EventInfliximab 5 mg/kg
pneumonia legionellaInfections and infestations1/159
erythemaSkin and subcutaneous tissue disorders1/159
Most frequent other events
Most frequent other events
EventInfliximab 5 mg/kg
pyrexiaGeneral disorders9/159
arthralgiaMusculoskeletal and connective tissue disorders8/159

Baseline characteristics

Age, Continuous
Age, Continuous(years)Infliximab 5 mg/kg
Mean44.15 ± 12.80
Sex: Female, Male
Sex: Female, Male(Participants)Infliximab 5 mg/kg
Female40
Male119
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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00687401
Lead sponsor
Merck Sharp & Dohme LLC
Collaborators
Centocor, Inc.
Responsible party
Sponsor
First posted
May 30, 2008
Start date
Jun 2006
Primary completion
May 2009
Completion
May 2009
Results posted
Dec 24, 2010
Last update
Apr 11, 2017

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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