Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis

3 1 1

What is this study about?

This clinical trial is focused on studying a condition known as Primary Progressive Multiple Sclerosis (PPMS). This is a type of multiple sclerosis where symptoms gradually worsen over time without any periods of improvement. The study is evaluating a treatment called Ocrelizumab, which is given as an infusion, meaning it is administered directly into the bloodstream through a vein. The trial aims to determine if a higher dose of Ocrelizumab is more effective than the currently approved dose in slowing down the progression of disability in people with PPMS.

Participants in the study will receive either the higher dose of Ocrelizumab, the approved dose, or a placebo. The study will monitor the participants over a period to see how the treatment affects their condition. The main goal is to see if the higher dose can better reduce the risk of disability progression, which is a measure of how the disease affects a person’s ability to perform daily activities. The study will also look at other factors, such as changes in brain volume and levels of certain proteins in the blood that are related to nerve damage.

In addition to Ocrelizumab, some participants may receive other medications like Paracetamol, Methylprednisolone, and Diphenhydramine Hydrochloride to manage symptoms or side effects. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. The trial will continue until the researchers have enough information to determine the effectiveness and safety of the higher dose of Ocrelizumab for treating PPMS.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of primary progressive multiple sclerosis (PPMS), and other criteria such as neurological stability and MRI results.

2 baseline measurements

Baseline measurements are taken to assess the current status of the condition. This includes the expanded disability status scale (EDSS) score and other functional assessments.

3 medication administration

The study involves the administration of ocrelizumab through intravenous infusion. The dosage and frequency are determined by the study protocol.

Additional medications include paracetamol 500 mg tablets taken orally, methylprednisolone 500 mg for injection or infusion, and diphenhydramine hydrochloride 50 mg tablets taken orally or intravenously as needed.

4 regular follow-up visits

Regular follow-up visits are scheduled to monitor the effects of the medication and assess any changes in the condition. These visits include clinical evaluations and laboratory tests.

5 progress evaluation

The primary goal is to evaluate the time to onset of confirmed disability progression (cCDP) sustained for at least 12 weeks. Secondary evaluations include various other measures of disease progression and response to treatment.

6 end of study assessments

At the end of the study period, final assessments are conducted to evaluate the overall impact of the treatment on the condition. This includes a comprehensive review of all collected data and outcomes.

Who Can Join the Study?

  • Must be between 18 and 55 years old at the time of screening.
  • Must have a diagnosis of Primary Progressive Multiple Sclerosis (PPMS) according to the revised McDonald criteria from 2017. This is a set of guidelines used to diagnose multiple sclerosis.
  • Must have an Expanded Disability Status Scale (EDSS) score between 3 and 6.5 at screening and baseline. The EDSS is a method of measuring disability in people with multiple sclerosis.
  • Must have a score of 2.0 or higher on the Functional Systems (FS) scale for the pyramidal system, which is related to findings in the lower body, at screening and baseline. The FS scale is used to assess different functions of the nervous system.
  • Must have a documented MRI of the brain showing abnormalities that are consistent with multiple sclerosis. An MRI is a type of scan that creates detailed images of the inside of the body.
  • Must be neurologically stable for at least 30 days before the start of the study and baseline assessments. This means there should be no significant changes in neurological condition during this period.

Who Cannot Join the Study?

  • Patients with any other type of multiple sclerosis besides Primary Progressive Multiple Sclerosis (PPMS) cannot participate. PPMS is a form of multiple sclerosis where symptoms gradually worsen over time.
  • Patients who have had a recent infection or are currently experiencing an infection are not eligible.
  • Individuals with a history of cancer, except for certain types of skin cancer, are excluded.
  • Patients with significant heart problems, such as heart failure or recent heart attack, cannot join the study.
  • People with severe liver disease are not eligible to participate.
  • Patients who have received certain treatments for multiple sclerosis in the past may be excluded.
  • Individuals who are pregnant or breastfeeding cannot take part in the trial.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
  • Anyone with a known allergy to the study medication or its ingredients cannot participate.
  • Patients with a history of drug or alcohol abuse may be excluded from the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
DKD HELIOS Klinik Wiesbaden GmbH Wiesbaden Germany
Instytut Psychiatrii I Neurologii Warsaw Poland
Noorderhart Pelt Belgium
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Hwrflirv Vmik dkwvocxu Barcelona Spain
Cvmieu Hwyqcewrhle Uhfhnaprldrxq Dd Cwyc Njyyqqtpg Caen France
Utiqemxwpnmmujmvxbbui Tctqtqpzc Alj Tuebingen Germany
Utkmwsblyw Cwheloxw Hqfdqgdb Vlmsom Do Ld Axirezuy Murcia Spain
Aawarme Otiejqzfavf Uthlcnyardsxb Cgoquqemfwui Dxojm Sllnnd E Drrjy Sotfrzv Dx Tlnnhj Turin Italy
Uwxhipxfdaujaajafonfm Mzlwvtpe Agr Munster Germany
Afxtbgz Uyekclndsw Hgbhlhed Aalborg Denmark
Apkjpin Ocqgrwwzrss Ukgokqbylumqe Fawlgewi Il Dx Nwswrn Naples Italy
Coko Dr Nxlxu Vandoeuvre Les Nancy France
Uqhqanjznbfb Lpkgwrf Leipzig Germany
Rzayfransxtobr Copenhagen Denmark
Csdnkm Hjmzatyezs Ulzmrstzirrri Dz Syowo Aawalxx Eifctx Porto Portugal
Iyntrmgc fcoe Kwadimwuv Ttjbiodivccroxrzwgv uew Irxfkdupjdxg Ufj gkopg Ulm Germany
Htyjbink Uumvkesxodycz Ppfhir Dq Hhliqw Da Mvfqucgbxwk Majadahonda Spain
Cirz Ctcwky Ccxkgqc Abaatrcxf Bimgd Arsuprvjol Braga Portugal
Hjidkwmm Uxogexyxrmojbl Ssatbralwt &oeveil Hivwmul dn Hzwosobhmdt STRASBOURG, Alsace France
4vr Glcybui Msqlkhly Hzhjstjf Os Aodynw Athens Greece
Mmdogbhkyndw Haewrjgg Fkj Anghyl Tdnjvkmld Ih Nfuybyisn Atb Pcnfoijrvc Sto Nmxe Ene Sofia Bulgaria
Ssifwr Vzvanjtty Kkjzal Mnn Owmaui Khzssl Kaposvar Hungary
Nhwvef Sjt z onsd Rzeszow Poland
Kfyzprxtkt Ftgv Fahelo Kdgpjn Kistarcsa Hungary
Ijavrepq Zykuoep Db Bliugkrjgougtjqma Oświęcim Poland
Glqjwlkmsi Dyt Hsakalhj Dy Lveptoupycapbzek Czldeuwjfz Dm Lkjlu Lomme France
Buumuinr Uoozxcbeta Hvlwgava Citdmp Besançon France
Hhaqxjsq Uwlsexyxsytba Qgftjszkqjr Mgxypu Pozuelo De Alarcon Spain
Glekjebntzroqxrus Vpeeptabh Pvby Afvzfr Egwwwxii Ounzim Kzbtbv Gyor Hungary
Naymgkkkggjq Baqwhwebo Sev z ootm Bydgoszcz Poland
Euqczxtd Hxwwyenp Athens Greece
Aqpfnlx Otsiyrudrkyerlnoourazerqs Sbqs Azjfl Rome Italy
Cro Gykilpfpvlblylgm Clermont Ferrand France
Fxbkfrrozc Ihyzqshj Nacoosapumu Nxsvlaugt Csuzghka Mwmedxq Pavia Italy
Eekwhwxge Swf z ohog Szczecin Poland
Mnfhfsxkzstgo Hwtelhkc fqb Amugvu Tgzrcvzrz Hpwkp apa Bgpel Ege Pleven Bulgaria
Mmdcbh Ccabniol Siq z ooqb Katowice Poland
Sfukydnpzbc Pdmieluou Zxgfkn Ogvdnk Zjusjyhwgm Wgyudrttwv Sezqnqj Shewgktquiptwga Nv 3 W Rdzzgxy Rybnik Poland
Nfgkgxhbowas Svn z ovzn Warsaw Poland
Awtascx Smhbj Sszurfwfz Txcrmxwahqag Dlmcr Vtzig Olvma Saronno Italy
Uys Mesjkna Tjhwwe Khtj Budapest Hungary
Ithhcvghwoiq Pptvmkyy Lwcclfzn Pxtsw dq hual ng moaj Kryxmi Riaaoo Lublin Poland
Edk Iwmflmnb Myemdmmi Swte Poznan Poland
Cdpkjew Nqmrwedoch Kapxwqpyb Sdxbuh Lodz Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
03.12.2020
Bulgaria Bulgaria
Not recruiting
03.12.2020
Denmark Denmark
Not recruiting
03.12.2020
France France
Not recruiting
03.12.2020
Germany Germany
Not recruiting
03.12.2020
Greece Greece
Not recruiting
03.12.2020
Hungary Hungary
Not recruiting
03.12.2020
Italy Italy
Not recruiting
03.12.2020
Poland Poland
Not recruiting
03.12.2020
Portugal Portugal
Not recruiting
03.12.2020
Spain Spain
Not recruiting
03.12.2020

Trial locations

Ocrelizumab: This medication is used in the treatment of multiple sclerosis, specifically for adults with primary progressive multiple sclerosis. The trial is investigating whether a higher dose of ocrelizumab is more effective than the currently approved dose in reducing the risk of disability progression. Ocrelizumab works by targeting specific cells in the immune system that are thought to contribute to the damage of nerve cells in multiple sclerosis.

Primary Progressive Multiple Sclerosis (PPMS) – This is a form of multiple sclerosis characterized by a gradual worsening of neurological function from the onset of symptoms, without early relapses or remissions. Unlike other types of multiple sclerosis, PPMS does not have clear episodes of attacks or recovery. The disease primarily affects the spinal cord and brain, leading to symptoms such as muscle weakness, difficulty walking, and problems with balance and coordination. Over time, individuals may experience increasing disability, with symptoms progressively worsening. The progression of PPMS can vary significantly among individuals, with some experiencing a steady decline and others having periods of stability.

Trial ID:
2023-506515-18-00
Protocol code:
BN42083
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Indapamide for Reducing Disability Progression in Adults with Primary and Secondary Progressive Multiple Sclerosis

    Recruiting

    2 1 1 1
    Investigated Drugs:
    The Netherlands
  • Safety and Feasibility of Home Use On-Body Injection System for Subcutaneous Ocrelizumab in Adults with Multiple Sclerosis

    Recruiting

    3 1 1
    Investigated Diseases:
    Investigated Drugs:
    France Italy Poland Spain