Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Multiple sclerosis is a condition which affects the brain and/or spinal cord, causing problems with vision, arm or leg movement, sensation or balance. The aim of this study is to assess whether a blood test called the Heidelberg Assay Panel can be used to predict which patients with early relapsing multiple sclerosis respond to treatment with the drug Octagam.

Who can participate?
Patients aged 18 or over with early relapsing multiple sclerosis

What does the study involve?
Participants are pre-classified using the Heidelberg Assay Panel as either responders or non-responders to Octagam, and are randomly allocated to be treated with either Octagam or interferon-beta/glatiramer acetate. Participants in all four groups receive either treatment over a period of up to 116 weeks, and are asked to give a small amount of blood for further tests, fill in a questionnaire and undergo some nervous-system-related tests. The multiple sclerosis relapse rates are compared between the four groups.

What are the possible benefits and risks of participating?
The benefits are that the participants’ health is monitored very thoroughly and more frequently than normal. There are no known risks of participating.

Where is the study run from?
Octapharma AG (Switzerland)

When is study starting and how long is it expected to run for?
June 2013 to September 2016

Who is funding the study?
Octapharma AG (Switzerland)

Who is the main contact?
Ms Barbara Pyringer

Trial website

Contact information



Primary contact

Ms Barbara Pyringer


Contact details

Octapharma Pharmazeutika Produktionsges.m.b.H
Oberlaaer Strasse 235

Additional identifiers

EudraCT number

2012-005086-12 number

Protocol/serial number


Study information

Scientific title

Prospective, multicentre, rater-blinded, active-controlled, randomised, 4-arm parallel-group phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis



Study hypothesis

The HAP score enables to accurately predict responders to Octagam 5% treatment in patients with early relapsing multiple sclerosis.

Ethics approval

Innsbruck EC, 06/06/2013, ref: UN5107

Study design

Prospective multicentre rater-blinded active-controlled randomised four-arm parallel-group study

Primary study design


Secondary study design

Randomised parallel trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Early relapsing multiple sclerosis (MS)


Group 1: Pre-classified as responders, receives the investigational medicinal product (IMP), Octagam 5%, 0.6 g/kg, which is a human immunoglobulin (Ig) solution with 5% protein content. This is administered intravenously (iv) in 4 week intervals.
Group 2: Pre-classified as responders receives the comparator product (Control): either interferon-beta subcutaneous (IFN-β sc) or glatiramer acetate (GA) according to the manufacturer’s prescribing information.
Group 3: Pre-classified as non-responders receives Octagam 5%. This is administered intravenously (iv) in 4 week intervals.
Group 4: Pre-classified as non-responders receives the comparator product (Control): either interferon-beta subcutaneous (IFN-β sc) or glatiramer acetate (GA) according to the manufacturer’s prescribing information
Duration of treatment in study is 104 weeks plus a follow-up period of 12 weeks.
The HAP score will be measured centrally in a designated lab.

Intervention type



Phase III

Drug names

Octagam 5%

Primary outcome measure

The primary endpoint is superiority with regard to decreased Annualised Relapse Rate (ARR) of Octagam 5% treatment in patients pre-classified as predicted responders compared to predicted non-responders.
Neurological monitoring at each visit and Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Functional Composite (MSFC) score at visits week 24, 52, 80, 104, 116

Secondary outcome measures

1. ARR of Octagam 5% treatment compared to active control
2. ARR of comparator treatment compared between predicted responders and non-responders to Octagam 5% treatment
3. Compare ARR of predicted responder to Octagam 5% treatment with both IMP treatment arms combined
4. Percentage of actual responders and non-responders in the 21-month period between 3 months after the first study treatment (“run-in” phase) and the end of treatment period at month 24

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Patients aged 18 years or above
2. Early diagnosis of the relapsing form of MS (≤ 5years) according to the revised McDonald criteria (1-3)
3. Patients who are at least 3 months on stable dosage of either IFN-β sc or GA and who did not receive the other first-line therapy before
4. Kurtzke Expanded Disability Status Scale (EDSS) less or equal to 3.5
5. Patients who experienced at least one medically confirmed relapse during the last 12 months or at least two such relapses in the last 24 months prior to study entry (but not within 30 days between last steroid treatment of relapse and start of screening ); subjects who relapse during the screening phase can be re-screened, once the relapse has resolved but earliest 30 days after the end of relapse treatment with steroids) or at least 1 T1 Gd+ lesion at screening

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Patients who have received treatment with immunoglobulins for any reason in the last 6 months
2. Patients who have received immunosuppressive treatments (e.g., azathioprine, mitoxantrone, cyclophosphamide) for any reason, in the past
3. Treatment with steroids (oral or parenteral, long-term, i.e. 30 days or more, not intermittent or burst, daily, ≥0.15 mg of prednisone or equivalent/kg/day) except relapse treatment with corticosteroids
4. Patients who have received monoclonal antibody therapy with natalizumab in the last 12 months
5. Patients who have ever received monoclonal antibody therapy with alemtuzumab, daclizumab, or ocrelizumab
6. Patients with severe renal function impairment as defined by serum creatinine values >120 µmol/L
7. Patients with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency (when the patient has antibodies against IgA)
8. Patients with a body weight higher than or equal to120 kg
9. Patients with a history of anaphylaxis after previous transfusions of blood or blood products
10. Patients for whom MRI is contraindicated or who are allergic to gadolinium (not complete)

Recruitment start date


Recruitment end date



Countries of recruitment

Austria, Bulgaria, Germany, Hungary, Russian Federation

Trial participating centre

Octapharma Pharmazeutika Produktionsges.m.b.H

Sponsor information


Octapharma AG (Switzerland)

Sponsor details

Seidenstrasse 2

Sponsor type




Funder type


Funder name

Octapharma AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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)

See: (added 21/06/2019)

Publication list

Publication citations

Additional files

Editorial Notes

21/06/2019: Added link to basic results (scientific). Added total final enrollment. 25/05/2017: Plain English summary added.