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PsoriasisPhase 3NCT00358670

Long-Term Effects of Infliximab in the Treatment of Moderate to Severe Psoriasis [Extension of Study P04271, NCT00251641] (P04563)

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a long-term, randomized, multi-center, open-label study of infliximab treatment in adults with moderate to severe plaque-type psoriasis. This study is the long-term extension of Study P04271 (NCT00251641); Study P04271 is a Phase 3b, randomized, parallel-group, multicenter, open-label, 26-week study comparing… Read more about this study

Who is it for?
Ages 18 to 75 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
441 participants
Where
No sites listed yet
Study dates
May 2006to 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have met all inclusion/exclusion criteria in Study P04271 (NCT00251641).
  • Subjects must have been originally randomized to infliximab in Study P04271.
  • Subjects must have completed the full 26 weeks of Study P04271.
  • Subjects must have remained on infliximab for the full 22 weeks of treatment in Study P04271.
  • Subjects must have achieved an improvement in Psoriasis Area and Severity Index (PASI) score >=75% from Baseline of Study P04271 to Week 26 of Study P04271.
  • Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
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  • Subjects are considered eligible according to the following tuberculosis (TB) criteria:
  • Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
  • Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication.
  • Subjects' Baseline (Visit 1) clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) must be within the following parameters:
  • Hemoglobin >=10 g/dL
  • White blood cells >=3.5 x 10^9/L
  • Neutrophils >=1.5 x 10^9/L
  • Platelets >=100 x 10^9/L
  • Serum creatinine <1.5 mg/dL (or <133 umol/L)
  • Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase levels as outlined in Protocol P04563.
  • Total bilirubin <2 x upper limit of normal [Note: If Baseline laboratory tests are not yet available, then the previous laboratory tests from Week 22 of the parent study (Study P04271) should be used for enrollment. When the Baseline laboratory tests become available, the investigator must apply the above parameters to determine a subject's eligibility.]
  • Subjects must be free of any clinically significant disease (other than plaque-type psoriasis or psoriatic arthritis) that would interfere with the study evaluations.
  • Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules.
  • Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must continue using such measures until 6 months after receiving the last infusion of study medication.
  • Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline.

Who cannot join

  • Subjects who have any significant ongoing adverse events (AEs) or AEs from Study P04271 (NCT00251641) that would prohibit further treatment with infliximab at the time of entry.
  • Subjects originally randomized to methotrexate or subjects who received methotrexate at any time during their participation in Study P04271.
  • Subjects who have non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular).
  • Subjects who have current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
  • Female subjects who are pregnant, nursing, and both men and women who are planning pregnancy during the study period or during the 6 months after receiving of the last infusion of study medication.
  • Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
  • Subjects who are staff personnel directly involved with this study.
  • Subjects who are family members of the investigational study staff.

About this study

Official title: A Long-Term Efficacy and Safety Study of Infliximab in the Treatment of Moderate to Severe Plaque-Type Psoriasis

This is a long-term, randomized, multi-center, open-label study of infliximab treatment in adults with moderate to severe plaque-type psoriasis. This study is the long-term extension of Study P04271 (NCT00251641); Study P04271 is a Phase 3b, randomized, parallel-group, multicenter, open-label, 26-week study comparing the efficacy and safety of infliximab versus methotrexate in the treatment of adult subjects with moderate to severe plaque-type psoriasis. The objectives of this study are to assess the efficacy and safety of long-term maintenance therapy versus intermittent therapy with 5 mg/kg infliximab in a moderate to severe plaque-type psoriasis population.

During an interim safety evaluation of the trial, a higher incidence of serious and severe infusion reactions was observed in the intermittent treatment arm, consisting of a re-induction cycle (maximum of 4 infusions at 0, 2, 6 and 14 weeks) after a period of no treatment compared with the maintenance arm (infusions every 8 weeks without an interruption of treatment). Consequently, the sponsor has terminated the trial. The label will be updated to reflect this new information relating to the use of a re-induction regimen with infliximab.

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

    Infliximab maintenance therapy

    intravenous (IV) infusion every 8 weeks, 5 mg/kg body weight (first infusion at Week 4/Visit 2).

  • infliximabBiological

    Also called SCH 215596, Remicade

    Infliximab intermittent therapy:

    Paricipants will receive no infliximab treatment until the Week 26 improvement in PASI from Baseline (original Study P04271 [NCT00251641] Baseline) is reduced by more than 50%. At that time, participants will receive an infliximab infusion, 5 mg/kg body weight. Participants may receive additional infusions at 0, 2, 6, and 14 weeks after the first infusion of the cycle (ie, a maximum of 4 infusions in each infusion cycle) as needed until they respond, defined as a >=75% improvement in PASI from the original Baseline in Study P04271. Subjects will receive no further treatment until they relapse again (ie, improvement in PASI from Baseline is reduced by more than 50%), at which time participants will receive another infusion cycle of up to 4 infusions, as described above. Throughout the study, intermittent treatment infusion cycles will be repeated whenever participants relapse.

Study groups in NCT00358670
Study groupRoleWhat they receive
Maintenance InfliximabActive comparatorInfliximab 5 mg/kg by body weight every 8 weeks
Receives: Biological: infliximab
Intermittent InfliximabExperimentalInfliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in Psoriasis Area and Severity Index (PASI) from the Study P04271 Baseline
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 Achieved Psoriasis Area and Severity Index 75 (PASI75) Response at Week 128

    PASI75 defined as the number of participants who achieved a >=75% improvement in Psoriasis Area and Severity Index (PASI) from the original Baseline in Study P04271 (NCT00251641).

    Measured: 128 weeks

Secondary outcomes (4)

  1. Number of Participants Who Achieved PASI75 Response at Week 52

    PASI75 defined as the number of participants who achieved a >=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)

    Measured: 52 weeks

  2. Number of Participants Who Achieved PASI75 Response at Week 100

    PASI75 defined as the number of participants who achieved a >=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)

    Measured: 100 Weeks

  3. PASI 6-month Area Under the Curve (AUC); (Time Adjusted Total PASI Score Over the 6 Month Period)

    The PASI 6-month AUC is a time adjusted total PASI score over the 6 month (180 days) period. The AUC is a continuous measurement (not a score on a scale); a lower value is considered better and a higher value is considered worse. The weighted average PASI score over 6 months (using all available PASI scores during a 6 month period [from Day 0 to 180 days]) is obtained by using PASI 6-month AUC /180 days.

    Measured: Day 0 to 180 days

  4. PASI 12-month AUC (Time Adjusted Total PASI Score Over the 12 Month Period)

    The PASI 12-month AUC is a time adjusted total PASI score over the 12 month (360 days) period. The AUC is a continuous measurement (not a score on a scale); and a lower value is considered better. The weighted average PASI score over 12 months (using all available PASI scores during a 12 month period [from Day 0 to 360 days]) is is obtained by using PASI 12-month AUC /360 days.

    Measured: Day 0 to 360 days

Timeline

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

  1. First posted1 Aug 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJan 2009
  4. Study completionJan 2009

Why it stopped: Infusion reactions during re-induction cycles after a period of no treatment. Please see "Purpose" section.

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00358670
Sponsor's protocol ID
P04563
Other IDs
EUDRACT NUMBER:2005-005367-28
Status last verified
Mar 2017
First submitted
31 Jul 2006
Last updated
11 Apr 2017
Data monitoring committee
Yes
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

Publications

  • Reich K, Wozel G, Zheng H, van Hoogstraten HJ, Flint L, Barker J. Efficacy and safety of infliximab as continuous or intermittent therapy in patients with moderate-to-severe plaque psoriasis: results of a randomized, long-term extension trial (RESTORE2). Br J Dermatol. 2013 Jun;168(6):1325-34. doi: 10.1111/bjd.12404.

    PubMed 23621698

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 21 inclusion and 8 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: stopped early, 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 19 Nov 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?

Number of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI75) Response at Week 128 (time frame: 128 weeks). 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 NCT00358670, which also lists 1 linked publication.

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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