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Chronic Plaque PsoriasisPhase 4EASYNCT00697593

ChangE From Any Systemic psoriasiS therapY to Raptiva

A Phase 4 study testing Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb) in people with Chronic Plaque Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Canada.

Terminated

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

Official record
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Trial summary

To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Plaque Psoriasis
What is being tested?
Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteCanada
Study dates
Jan 2008to Apr 2009
Phase
Phase 4
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

  • Are at least 18 years old.
  • Have plaque psoriasis with an sPGA score of at least moderate or severe at time of initiation of previous systemic treatment.
  • Are transitioning from methotrexate, cyclosporine, retinoids, PUVA or NBUVB and initiating treatment with Raptiva according to the decision of the investigator and in accordance with the indication and the recommendations of the Raptiva Investigator Brochure, i.e. to which they have failed to respond, have a contraindication to or are intolerant of other systemic therapies.
  • Agree to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
  • Have given written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
  • Women of childbearing potential must use appropriate contraception during treatment and up to the last study visit (safety follow-up visit). For men, it is also mandatory to practice contraception during participation in the trial, as there are no existing data on the effect of Raptiva on spermatogenesis.
  • Discontinuation of any investigational drug or treatment 3 months prior to study start or as per washout requirements from previous protocol.
  • No primary vaccinations (e.g., tetanus, booster, influenza vaccine) for at least 14 days prior to first dose of study drug.For the purposes of this trial, women of childbearing potential is defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive."

Who cannot join

  • Any contra-indication to Raptiva, according to the Investigator Brochure, or as follows:
  • Hypersensitivity to Raptiva or to any of the excipients.
  • Subjects with history of malignancies.
  • History of active tuberculosis (TB) or currently undergoing treatment for TB. Purified Protein Derivative (PPD) testing or chest X-ray is required for high-risk subjects. Subjects with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded.
  • Subjects with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
  • Subjects with immunodeficiencies.
Show all 14Show fewer
  • Simultaneous participation in another clinical trial.
  • Subjects experiencing a psoriasis exacerbation during screening period.
  • Subjects who have previously been on Raptiva treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (vaccination, or infection) then the subject can be included in this study.
  • History of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
  • History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia.
  • Hepatic enzyme levels =/>3 times the upper limit of normal or serum creatinine level =/>2 times the upper limit of normal.
  • Pregnant or breast-feeding.
  • Any medical condition (prior or existing) that, in the judgment of the investigator or sponsor, could jeopardize the subject's safety following exposure to study drug.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Probity Medical Research

    City Waterloo, Ontario, N2J 1C4

Other trials in Canada

About this study

Official title: A Phase IV Open Label Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Transitioning From Previous Systemic Antipsoriasis Therapies (Methotrexate, Cyclosporine, Retinoids or Psoralen-Ultraviolet Light A (PUVA), Narrow-Band Ultraviolet Light B (NBUVB) to Raptiva 1mg/kg/ Week Therapy.

To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose.

Being tested
Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)
Keywords
Efalizumab, Chronic Plaque Psoriasis, Transition from systemic therapies on to Efalizumab

What participants receive

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

  • Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)Drug

    Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.

Study groups in NCT00697593
Study groupRoleWhat they receive
EfalizumabExperimentalNot described
Receives: Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)

What is being measured

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

  1. Hematology - Hematocrit

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  2. Hematology - Hemoglobin

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  3. Hematology - Red Blood Cell Count

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  4. Hematology - White Blood Cell Count

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  5. Hematology - Neutrophils

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  6. Hematology - Eosinophils

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  7. Hematology - Basophils

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  8. Hematology - Monocytes

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  9. Hematology - Lymphocytes

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  10. Hematology - Platelet Count

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  11. Biochemistry - Sodium

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  12. Biochemistry - Potassium

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  13. Biochemistry - Creatinine

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  14. Biochemistry - Total Bilirubin

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  15. Biochemistry - Aspartate Transaminase (AST)

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  16. Biochemistry - Alanine Transaminase (ALT)

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  17. Biochemistry - Alkaline Phosphatase

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  18. Biochemistry - Glutamyl Transferase

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  19. Biochemistry - Urea

    Blood samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  20. Biochemistry - C-Reactive Protein (CRP)

    Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L

    Measured: Week 12 / Early Termination

  21. Urinalysis - pH

    Urine samples were taken for clinical laboratory testing

    Measured: Week 12 / Early Termination

  22. Urinalysis - Protein

    Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine

    Measured: Week 12 / Early Termination

  23. Urinalysis - Ketones

    Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine

    Measured: Week 12 / Early Termination

  24. Urinalysis - Glucose

    Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine

    Measured: Week 12 / Early Termination

  25. Urinalysis - Blood

    Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine

    Measured: Week 12 / Early Termination

  26. Urinalysis - Nitrite

    Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine

    Measured: Week 12 / Early Termination

  27. Urinalysis - Leukocytes Esterase

    Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine

    Measured: Week 12 / Early Termination

  28. Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis

    Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above

    Measured: Week 12 / Early Termination

Secondary outcomes (1)

  1. Static Physician's Global Assessment (sPGA)

    Number of subjects who achieve an Static Physician's Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85).

    Measured: 12 Weeks/Early Termination

Timeline

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

  1. First posted16 Jun 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionApr 2009
  4. Study completionApr 2009

Why it stopped: The study was terminated after the European Medicines Agency recommended to suspend the marketing authorisation of Raptiva in the European Union

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00697593
Sponsor's protocol ID
27809
Acronym
EASY
Status last verified
Jan 2014
First submitted
11 Jun 2008
Last updated
13 Feb 2014

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb) in people with Chronic Plaque Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Canada.

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 8 inclusion and 14 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 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 30 Aug 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?

Hematology - Hematocrit (time frame: Week 12 / Early Termination). The study lists 28 primary outcomes in all. 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 NCT00697593.

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 13 Feb 2014.

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