Contact information
Type
Scientific
Primary contact
Dr Stefan Wietek
ORCID ID
Contact details
Octapharma PPG
Vienna CR&D Office
Oberlaaer Str. 235
Vienna
1100
Austria
+43 (0)1 61032 1778
stefan.wietek@octapharma.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GAM-25
Study information
Scientific title
Acronym
Study hypothesis
To find a panel of laboratory parameters which might be able to predict the clinical outcome of treatment of patients with relapsing-remitting multiple sclerosis (MS) with Octagam®.
Ethics approval
1. EC Medical University of Innsbruck (Austria) - includes approval for Linz and Klagenfurt; approval received on the 9th January 2009 and final approval for additional study materials received on 22nd January 2009
2. EC Heidelberg (Germany) - includes approval for study sites at Heidelberg, Asbach, Berlin, Hamburg, Regensburg, Rostock; approval received on the 31st March 2009
Study design
Prospective exploratory open label multicentre phase II trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Multiple sclerosis
Intervention
Octagam® 5% (12 infusions 0.4 g/kg every 4 weeks).
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
A panel of lab parameters (components of cells of the immune system, serum proteins, gene expression, single nucleotide polymorphism [SNP] analysis) will be analysed at baseline, 12 - 24 hours after end of the first infusion, and 24 and 48 weeks after the first Octagam® administration and the clinical course of the disease will be monitored by relapse activity, EDSS and Multiple Sclerosis Functional Composite (MSFC) at predefined time points. Statistical analysis will test whether any of the lab parameters of the HAP panel or the B-cell antibody response panel might be able to predict the clinical outcome observed following Octagam® 5% treatment. The proportion of subjects clinically responding to Octagam® 5% will be determined.
Secondary outcome measures
Lesion load in brain MRI imaging (T2 weighted, T1 weighted, Gd-enhancing lesion load) after treatment will be compared to lesion load before treatment.
Overall trial start date
20/03/2009
Overall trial end date
20/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Subjects aged greater than or equal to 18 years, either sex
2. Multiple sclerosis (MS) according to the revised McDonald criteria
3. Relapsing-remitting form of MS
4. First-line disease modifying treatments (interferon-beta [IFN-beta] or glatiramer acetate) are contraindicated or not tolerated
5. Kurtzke's Expanded Disability Status Scale (EDSS) between 0 and 3.5 (0 to less than 3.5)
6. Subjects who experienced at least one relapse during the last 12 months or at least two relapses in the last 24 months prior to study entry
7. Freely given, fully informed written consent obtained from subject
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Subjects who have received treatment with immunoglobulins for any reason previously
2. Subjects who have received immuno-suppressive treatments (e.g. azathioprine, mitoxantrone, cyclophosphamide) for any reason previously except relapse treatment with corticosteroids
3. Subjects who have received disease modifying first-line treatments with IFN-beta during the last 8 weeks or with glatiramer acetate during the last 16 weeks
4. Subjects who have received any monoclonal antibody therapies (e.g. natalizumab) previously
5. Subjects who had a relapse within 3 months prior to study entry
6. Subjects with severe renal function impairment as defined by serum creatinine values greater than 24 mg/l
7. Subjects with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the subject has antibodies against IgA
8. Subjects with a body weight of greater than 120 kg
9. Subjects with a history of anaphylaxis after previous transfusions of blood or blood products
10. Subjects for whom magnetic resonance imaging (MRI) is contraindicated or who are allergic to gadolinium
11. Pregnant or lactating women
12. Subjects who delivered a baby within 12 months before study entry (including miscarriage and stillbirth)
13. Subjects with a diagnosis of significant depression
14. Subjects with known chronic infectious diseases or malignant disease
15. Subjects with known antibody deficiencies or other autoimmune diseases other than MS
16. Subjects participating in another study during the course of this study or during the past 6 months or who have ever participated in a study investigating in new disease modifying or immunosuppressive drugs
Recruitment start date
20/03/2009
Recruitment end date
20/09/2010
Locations
Countries of recruitment
Austria, Germany
Trial participating centre
Octapharma PPG
Vienna
1100
Austria
Sponsor information
Organisation
Octapharma AG (Switzerland)
Sponsor details
Seidenstr. 2
Lachen
CH-8853
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Octapharma AG (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list