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PsoriasisPhase 3NCT00254982

Infliximab in High Need Versus Low Need Psoriasis Patients: The IHELP Study (Study P04320)(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

This is an open-label, multicenter, parallel-group comparison study of the efficacy, safety, and tolerability of infliximab therapy in adult patients suffering from chronic plaque psoriasis (psoriasis vulgaris). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Infliximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
593 participants
Where
No sites listed yet
Study dates
Aug 2005to Sep 2006
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

  • Written informed consent by the patient for study participation, prior to protocol specific procedures.
  • Patients who are 18 years of age or older at time of enrollment, may be male or female and of any race.
  • Diagnosis of plaque-type psoriasis (psoriasis vulgaris) at least 6 months prior to screening.
  • Plaque-type psoriasis covering at least 10% of total body surface area.
  • Psoriasis Area and Severity Index (PASI)-Score of 12 or greater.
  • GROUP I ("high need") patients: adult patients with moderate to severe plaque psoriasis who are either not controlled by, or are intolerant to or have contraindications to at least two currently available systemic therapies (e.g. photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). GROUP II ("low need") patients: adult patients with moderate to severe plaque psoriasis who have undergone pre-treatment with no more than one currently available systemic therapy (e.g. photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). A patient showing contraindications towards two systemic treatments, who has never been pretreated with a systemic therapy will be assigned to GROUP II ("low need").
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  • Patients must have had a chest x-ray (preferably posteroanterior and lateral) within 3 months prior to first infusion with no evidence of malignancy, infection (e.g. tuberculosis) or fibrosis.
  • Laboratory test results: liver enzymes (aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT) and alkaline phosphatase) must be within 1.5 times the upper limit of normal range (ULN), total bilirubin <=1.0 ULN, serum creatinine <1.5 mg/dL (must be available at Baseline).
  • Patients must agree to avoid prolonged sun exposure or other ultraviolet light sources during the study.
  • Women of child-bearing potential must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for six months after stopping the medication. Acceptable methods of contraception include abstinence, condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (e.g. hysterectomy or tubal ligation).
  • Women of child-bearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) at Screening (must be available at Baseline).
  • Baseline PASI-Score of 12 or greater.

Who cannot join

  • Patients suffering from active or latent tuberculosis. Prior to the start of treatment with infliximab tuberculosis needs to be excluded following the recommendations published by the German Paul Ehrlich Institute.
  • Patients who have had or have a serious infection (e.g. abscess, pneumonia or pyelonephritis) or who have been hospitalized or received treatment with intravenous antibiotics during the previous 2 months.
  • Patients who are known to be infected with human immunodeficiency virus, hepatitis B or C virus, prior or current opportunistic infections (within the last six months, Herpes zoster within the last 2 months).
  • Patients suffering from congestive heart failure including medically controlled asymptomatic patients.
  • History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
  • Patients who have current signs and symptoms or history of systemic lupus erythematosus.
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  • Patients suffering from non-plaque psoriasis, e.g. erythrodermic, guttate or pustular forms. The presence of psoriasis-arthritis is no exclusion criterion.
  • Patients suffering from current drug induced psoriasis (e.g. a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers or calcium-channel-blockers). If the patient takes one of those substances on a regular basis, it should be on a stable dose for at least three weeks prior to Baseline.
  • Patients suffering from severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric diseases, that, in the opinion of the investigator, would interfere with the study evaluations or safe or optimal participation in the study.
  • Any known malignancy during the last five years (except basal cell carcinoma), any history of lymphoproliferative disease.
  • Patients who have received any systemic psoriasis therapy (e.g. immunosuppressant) or lithium within 28 days or baseline visit.
  • Patients pretreated with etanercept or efalizumab within 28 days of Baseline.
  • Patients previously treated with infliximab.
  • Patients who have used topical treatments that could affect PASI evaluation (e.g. corticosteroids, anthralin, topical vitamin D derivates) within 2 weeks of baseline visit, except special areas like head or hands.
  • Patients who have used any investigational drug within 3 months of Baseline.
  • Patients with allergy/sensitivity to study drug or its excipients.
  • Women who are breast-feeding, pregnant, or intend to become pregnant.
  • Patients with any clinically significant condition or situation, other than the condition being studied.
  • Patients who are participating in any other clinical study.
  • Patients who are part of the staff personnel directly involved with this study.
  • Patients who are a family member of the investigational study staff.
  • Patients who have used any investigational drug within 3 months before Baseline.
  • Patients who have received any systemic psoriasis therapy (e.g. immunosuppressants) or lithium within 28 days of baseline visit.

About this study

Official title: An Open-Label Study to Determine Equivalence in Efficacy, Organ Safety and Systemic Tolerability Between Infliximab in GROUP I ("High Need") and GROUP II ("Low Need") Patients Suffering From Chronic Plaque Psoriasis (Psoriasis Vulgaris)

This is an open-label, multicenter, parallel-group comparison study of the efficacy, safety, and tolerability of infliximab therapy in adult patients suffering from chronic plaque psoriasis (psoriasis vulgaris). Patients will be assigned to GROUP I ("high need") or GROUP II ("low-need") by the investigator according to their previous psoriasis treatment.

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 Remicade, SCH 215596

    Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.

Study groups in NCT00254982
Study groupRoleWhat they receive
Group 1 (high-need)ExperimentalAdult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept).
Receives: Biological: Infliximab
Group II (low-need)ExperimentalAdult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept).
Receives: Biological: Infliximab

What is being measured

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

  1. Proportion of Participants Achieving a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score

    PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. 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).

    Measured: Baseline and Week 22

Timeline

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

  1. First posted17 Nov 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionSep 2006
  4. Study completionSep 2006

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
Parallel groups
Masking
None (open label)
Enrolment
593 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00254982
Sponsor's protocol ID
P04320
Other IDs
2005-001243-28, 2005
Status last verified
Oct 2015
First submitted
15 Nov 2005
Last updated
12 Oct 2015
Data monitoring committee
No

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 12 inclusion and 23 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 12 Oct 2015. 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 5 Jul 2010). 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?

Proportion of Participants Achieving a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score (time frame: Baseline and Week 22). 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 NCT00254982.

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 12 Oct 2015.

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