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PsoriasisPhase 3TIPSNCT00686686

Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP)(Study P04555)(COMPLETED)

A Phase 3 study testing Infliximab in people with Psoriasis, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Subjects with psoriasis will receive intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 (induction therapy) to evaluate the efficacy of infliximab at Week 18. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Psoriasis
What is being tested?
Infliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
No sites listed yet
Study dates
Dec 2007to Apr 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70 years of age at time of enrollment; male or female.
  • Women of childbearing potential and all men must be using adequate birth control measures and should continue using such measures until 6 months after receiving the last infusion of study agent.
  • Plaque-type psoriasis with evidence of mild to moderate psoriasis elsewhere or Psoriasis Pustulosa Palmo Plantaris (PPPP) of 6 months duration at least.
  • Adhere to study visit schedule and other protocol requirements.
  • Capable of giving informed consent prior to any study related procedures.
  • Avoid prolonged sun exposure, including tanning booths or other ultraviolet (UV) light sources during the study.
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  • Eligible according to country-specific tuberculosis (TB) screening, eligibility assessment, and prevention rules.
  • Chest x-ray within 3 months prior to first infusion with no evidence of malignancy, infection, or fibrosis.
  • Screening laboratory test results within parameters specified in protocol.

Who cannot join

  • Have any other form of psoriasis besides palmoplantaris and the pustular form.
  • Pregnant, nursing, or planning pregnancy within 6 months after last infusion.
  • Previous treatment with infliximab or any therapeutic agent targeted at reducing tumor-necrosis factor (TNF), including but not limited to etanercept, thalidomide, CDP870, or D2E7.
  • Other inflammatory disease that might confound the evaluations of benefit from the infliximab therapy, including but not limited to, rheumatoid arthritis (RA), ankylosing spondylitis, systemic lupus erythematosus, Lyme disease.
  • Used any investigational drug within the previous 1 month or 5 times the half life of the investigational agent, whichever is longer, or 3 months for any biologic of unknown half life.
  • Received any systemic medications/treatments that could affect psoriasis or PASI evaluation within 1 month prior to study.
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  • Used topical medications/treatments that could affect psoriasis or PASI evaluation within 2 or 4 weeks of baseline visit.
  • Treated with any anti-CD4 antibody in the last 6 month.
  • Received any systemic immunosuppressive within 4 weeks prior to first infusion.
  • Received within 3 months prior to first infusion or are expected to receive any live virus or bacterial vaccinations during the trial or up to 3 months after the last infusion.
  • History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection, or open, draining or infected skin wounds or ulcers.
  • Serious infection or been hospitalized or received IV antibiotics for an infection during the previous 2 months.
  • Have or had opportunistic infection.
  • Herpes zoster infection within 2 months of baseline.
  • Infected with human immunodeficiency virus (HIV), hepatitis B or C.
  • History of any clinically significant adverse events (AEs) to murine or chimeric proteins or human/murine recombinant products.
  • Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
  • History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
  • Systemic lupus erythematosus.
  • Transplanted organ.
  • History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location.
  • Malignancy within previous 5 years.
  • Concomitant diagnosis of congestive heart failure (CHF).
  • Unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
  • Substance abuse problem within previous 3 years.
  • Hypersensitivity reaction/adverse reaction to paracetamol/acetaminophen, antihistamines, topical corticosteroids.
  • Participation in another trial using an investigational agent or procedure during this trial.

About this study

Official title: A Multi Center, Open Label, Single-Arm Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP), Including the Pustular Form (PsPPP)

Subjects with psoriasis will receive intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 (induction therapy) to evaluate the efficacy of infliximab at Week 18. Subjects who achieved >=75% improvement in Psoriasis Pustulosa Palmoplantaris Area and Severity Index (PPPASI) score at Week 8 AND had deterioration of PPPASI score of 50% from Week 8 until Week 12 were to receive an additional infusion at Week 12.

Conditions
Psoriasis
Being tested
Infliximab
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfliximabBiological

    Also called SCH 215596, Remicade

    Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.

Study groups in NCT00686686
Study groupRoleWhat they receive
Infliximab 5 mg/kgExperimentalIntravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
Receives: Biological: Infliximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Achieve at Least 75% Improvement in Palmoplantar Psoriasis Activity Severity Index (PPPASI) After 3 Infusions.

    The PPPASI score is an overall score of disease signs: extent, scales, erythema, erosions (fissures), induration and pustules. "Extent" is rated on a scale range from 0-6; all other signs are rated on a scale range from 0 to 4 in a target palm and/or sole. Total score range:0-26. A reduction in score is considered an improvement.

    Measured: Baseline and Week 8

Secondary outcomes (4)

  1. Number of Participants Who Achieve a Moderate Response.

    Moderate response is defined as a 50% to 75% reduction in PPPASI score from baseline.

    Measured: Baseline and Week 8

  2. Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18.

    The Physician Static Global Assessment (PGA) documents the physician's assessment of the subject's psoriasis status according to the following categories: induration, scaling, and erythema. Each category is rated from 0 to 5, where 0 represents no evidence of induration/scaling/erythema ("clear"), 1 represents "minimal" induration/scaling/erythema, and 5 represents the most severe induration/scaling/erythema.

    Measured: Weeks 12 and 18

  3. Number of Participants Who Respond to the Fourth Infusion.

    >=25% reduction in PPPASI score would be considered a response.

    Measured: Week 12 and Week 18

  4. Dermatology Life Quality Index (DLQI)

    The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a subject's QOL. It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI was completed by the subject prior to the PPPASI and PGA evaluations.

    The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionFeb 2009
  4. Study completionApr 2009

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00686686
Sponsor's protocol ID
P04555
Acronym
TIPS
Status last verified
Mar 2017
First submitted
27 May 2008
Last updated
11 Apr 2017
Data monitoring committee
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infliximab in people with Psoriasis, run by Merck Sharp & Dohme LLC.

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 9 inclusion and 27 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 11 Apr 2017. 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 23 Feb 2011). 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 Who Achieve at Least 75% Improvement in Palmoplantar Psoriasis Activity Severity Index (PPPASI) After 3 Infusions. (time frame: Baseline and Week 8). 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 NCT00686686.

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 11 Apr 2017.

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