Condition category
Nervous System Diseases
Date applied
18/03/2009
Date assigned
18/03/2009
Last edited
10/04/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.octapharma.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes