Condition category
Nervous System Diseases
Date applied
04/06/2013
Date assigned
26/06/2013
Last edited
14/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Ms Barbara Pyringer

ORCID ID

Contact details

Octapharma Pharmazeutika Produktionsges.m.b.H
Oberlaaer Strasse 235
Vienna
A-1100
Austria

Additional identifiers

EudraCT number

2012-005086-12

ClinicalTrials.gov number

Protocol/serial number

GAM-27

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

Acronym

PREDICT

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

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Early relapsing multiple sclerosis (MS)

Intervention

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

Drug

Phase

Phase III

Drug names

Octagam 5%

Primary outcome measures

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

30/06/2013

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

216

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

30/06/2013

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Austria, Bulgaria, Germany, Hungary, Russian Federation

Trial participating centre

Octapharma Pharmazeutika Produktionsges.m.b.H
Vienna
A-1100
Austria

Sponsor information

Organisation

Octapharma AG (Switzerland)

Sponsor details

Seidenstrasse 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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes