To investigate the ability of the Heidelberg Assay Panel (HAP) score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis
| ISRCTN | ISRCTN82177408 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82177408 |
| EudraCT/CTIS number | 2012-005086-12 |
| Secondary identifying numbers | GAM-27 |
- Submission date
- 04/06/2013
- Registration date
- 26/06/2013
- Last edited
- 21/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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
Contact information
Scientific
Octapharma Pharmazeutika Produktionsges.m.b.H
Oberlaaer Strasse 235
Vienna
A-1100
Austria
Study information
| Study design | Prospective multicentre rater-blinded active-controlled randomised four-arm parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 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(s) | Innsbruck EC, 06/06/2013, ref: UN5107 |
| 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 manufacturers 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 manufacturers 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 30/06/2013 |
| Overall study end date | 30/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 216 |
| Total final enrolment | 174 |
| 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 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
Study participating centre
A-1100
Austria
Sponsor information
Industry
Seidenstrasse 2
Lachen
CH-8853
Switzerland
"ROR" |
https://ror.org/002k5fe57 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 21/06/2019 | No | No |
Editorial Notes
21/06/2019: Added clinicaltrialsregister.eu link to basic results (scientific). Added total final enrollment.
25/05/2017: Plain English summary added.
