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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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19 March 2012 |
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Main ID: |
EUCTR2006-004892-36-SE |
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Date of registration:
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09/02/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An open randomized and comparative study on the efficacy and safety of additional treatment of subcutaneous immunoglobulin (Subcuvia) during cessation of Prednisolon in patients with active systemic lupus erythematosus (SLE)
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Scientific title:
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An open randomized and comparative study on the efficacy and safety of additional treatment of subcutaneous immunoglobulin (Subcuvia) during cessation of Prednisolon in patients with active systemic lupus erythematosus (SLE) |
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Date of first enrolment:
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15/03/2007 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004892-36 |
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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: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
· Patients with SLE during active illness phase defined as SLEDAI 2K 4 or higher
· Patients with skin or joint engagement and/or serositis, low-grade hemolytic anemia and vasculitis.
· Patients aged > 18 years and < 70 years, of either gender
· Signed written informed consent of the patient.
· Women of childbearing potential must use reliable contraception methods during the study period.
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:
· Patients with life-threatening manifestation including glomerulonephritis, neuropsychiatric involvement, systemic vasculitis
· Patients with M-components with and without rheumatoid factor activity
· Known hypersensitivity to any of the drug components
· Bleeding disorder requiring treatment
· Antiphospholipid syndrome
· Severe infections, malignancy, severe cardiovascular disorder
· Females who are currently pregnant or breast feeding, or who plan to become pregnant during the course of the study.
· Patients treated with hydroxychlorochin, azathioprine, mycofenolate-mofetil and methotrexate if not on stable treatment for > 3 months
· Patients treated with immunomodulating and/or cytostatic drugs (cyclophosphamide, ciclosporin-A within 6 months and anti-B cell therapy (rituximab) within 1 year.
· Patients treated with anticoagulant drugs e.g. warfarin or heparin. Treatment with low dose of acetylsalicylic acid (trombyl® is allowed
· Patients treated with Subcuvia® / or other immunoglobulin within the previous 12 months.
· Patients who are participating in any other clinical studies, or who have participated in such a study within the previous six months.
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 (SLE)
MedDRA version: 9.1
Level: LLT
Classification code 10040967
Term: SLE
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Intervention(s)
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Trade Name: Subcuvia
Pharmaceutical Form: Solution for injection
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Primary Outcome(s)
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Main Objective: To evaluate the ability to conclude Prednisolone cessation plan in patients treated with Subcuvia, compared with patients who are not recevning additional Subcuvia treatment.
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Primary end point(s): Failure to perform reduction of Prednisolone according to a predetermined scheme due to new or recurring disease activity according to definitions given in the BILAG scoring system.
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Secondary Objective: Safety
Regression of illness and normalization of parameters such as autoantibody levels, plasma concentrations of complement components and cytokine levels.
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Secondary ID(s)
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SLE subcuvia 04 Sep 2006
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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