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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
EUCTR2005-000706-31-ES |
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Date of registration:
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23/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE
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Scientific title:
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE |
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Date of first enrolment:
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25/07/2005 |
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Target sample size:
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300 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000706-31 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Germany
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Italy
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
-Male or female, 18 years and older;
-Signed written informed consent obtained prior to study entry;
-Has SLE by American College of Rheumatology revised criteria (meets at least 4 criteria);
-Has had SLE for at least 6 months prior to study entry;
-Has at least one elevated lupus-associated autoantibody level at study entry;
-Has BILAG index B level activity in at least 2 body/organ systems;
-Receving oral corticosteroids (prednisone, 7.5- 20 mg/day, or equivalent) at stable levels for at least 4 weeks prior to study entry; and
-Receiving at least an immunosuppresive on a stable regimen for at least 8 weeks prior to study entry, or else an antimalarial on a stable regimen for at least 12 weeks prior to study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
-Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test;
-Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control during and for a period of 6 months after the completion of the study;
-Active severe lupus disease; (defined by BILAG index A level activity in any body/organ system);
-Treatmen with rituximab or other anti-B-cell ABs within 12 months;
-Allergy to murine or human ABs;
-Experimental therapy or any therapy with human or murine ABs within 3 months;
-Cyclophosphamide, cyclosporin, intravenous, joint or IM injection of corticosteroids, or any IMPs within 4 weeks;
-Thrombosis, spontaneous or induced abortion, stillbirth or live birth, within 4 weeks;
-Patients with antiphospholipid ABs AND history of thromboembolic events;
-On oral anticoagulants within 4weeks;
-History of malignancy (except basal cell or squamous cell carcinoma, cervical CIS);
-Active infection receiving antibiotics within 7 days of screening or infection requiring hospitalization or herpes zoster treatment within 4 weeks; long-term infectious diseases (tuberculosis, fungal infections) active within 2 years;
-Known HIV, hepatitis B or C infection, or other immunosuppressive states;
-Live vaccine within 4 weeks;
-Hematological abnormalities not attributed to systemic lupus erythematosus;
-Liver transaminases or alkaline phosphatase > 3 X upper limit of normal and not attributed to SLE;
-Serum creatinine > 2.5 mg/dL or clinically significant increases within 4 weeks, or proteinuria > 3.5 mg/day; and
-Sustance abuse or other concurrent medical conditions that, in the investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
Classification code 10042945
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Intervention(s)
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Product Name: Epratuzumab
Product Code: IMMU-103
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Epratuzumab
CAS Number: 205923-57-5
Current Sponsor code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Main Objective: The primary study objective is to demonstrate that epratuzumab is effective for improvement of the signs and symptoms of SLE.
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Secondary Objective: -To evaluate the effectiveness of epratuzumab in improving signs and symptoms of SLE and in maintaining disease control.
-To evaluate the ability of epratuzumab to reduce the use of corticosteroids and other lupus medications.
-To demonstrate the safety of epratuzumab in patients with SLE.
-To assess the effect of adding epratuzumab to standard care on the quality of life of patients with SLE.
Supplemental endpoints:
-Time-to reflare (new/recurrent BILAG A or B) among patients with no BILAG index B (or A) scores in any body/organ system at 4 weeks as well as the proportion of ptients with these reflares.
-Proportion of patients able to maintain succesful steriod-tapering from week 24 to week 48
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Primary end point(s): The primary endpoint is the proportion of responders, i.e., those patients not considered treatment failures and without BILAG index A or B level activity in any body/organ system at any of the post-treatment evaluation from 4 weeks to 24 weeks.
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Secondary ID(s)
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2005-000706-31-GB
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IMMU-103-04
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 11/07/2005
Contact:
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