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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.
Register: EUCTR
Last refreshed on: 29 May 2012
Main ID:  EUCTR2005-000706-31-GB
Date of registration: 19/04/2005
Prospective Registration: Yes
Primary sponsor: Immunomedics, Inc.
Public title: 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
Scientific title: 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
Date of first enrolment: 13/05/2005
Target sample size: 300
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000706-31
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase: 
Countries of recruitment
Germany Italy Spain United Kingdom
Contacts
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Key inclusion & exclusion criteria
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 a positive ANA at study entry;
-Has BILAG index B level activity in at least 2 body/organ systems;
-Receiving oral corticosteroids (prednisone, 5.0- 20 mg/day, or equivalent) at stable levels for at least 4 weeks prior to study entry; and
-Receiving at least an immunosuppressive for at least 8 weeks, or else an antimalarial for at least 12 weeks, with stable dose regimens for at least 4 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 systmem);
-Treatment with Lymphostat B, or CTLA4-Ig within 6 months or 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 injections of corticosteroids exceeding 120 mg methylprednisolone, 60 mg triamcinolone, or equivalent; intravenous immunoglobulins (IVIG), 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 4 weeks;
-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
-Substance 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
Health Condition(s) or Problem(s) studied
Systemic Lupus Erythematosus
Classification code 10042945
Intervention(s)

Product Name: Epratuzumab
Product Code: IMMU-103
Pharmaceutical Form: Concentrate for solution for infusion
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

Primary Outcome(s)
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 patients with these reflares.
-Proportion of patients able to maintain successful steroid-tapering from week 24 to week 48
Main Objective: The primary study objective is to demonstrate that epratuzumab is effective for improvement of the signs and symptoms of SLE.
Primary end point(s): The primary efficacy endpoint evaluated at 24 weeks is a patient response variable with three ordered categories: complete response (CR), partial response (PR) and non-response (NR).
To have a response status of CR or PR, a patient must not be considered a treatment failure. If the patient also satisfies the protocol-defined steroid-tapering criterion at 24 weeks and does not have any BILAG Index B (or A) score in any body/organ system at any post-treatment evaluation time-point from weeks 4 to 24, the patient will be assigned a CR status. However, if the patient either (i) does not have any BILAG Index B (or A) score in any body/organ system at any post-treatment evaluation time-point from weeks 4 to 24 but does not satisfy the protocol-defined steroid-tapering criterion at 24 weeks, or (ii) satisfies the protocol-defined steroid-tapering criterion at 24 weeks and shows a reduction of at least two BILAG B scores at any post-treatment evaluation time-point from weeks 4 to 24 but without completely eliminating all BILAG B scores, that patients will be assigned a PR status. A patient who does not qualify for a CR or PR status is assigned a NR status.
Secondary Outcome(s)
Secondary ID(s)
IMMU-103-04
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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