AzTrials
AzTrials

Multiple Sclerosis, Relapsing-RemittingPhase 3RIDOSE-MSNCT03979456

RItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MS

A Phase 3 study testing Rituximab in people with Multiple Sclerosis, Relapsing-Remitting, run by Karolinska Institutet at 17 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

A randomized trial of long-term dosage of rituximab in multiple sclerosis Read more about this study

Who is it for?
Ages 20 to 52 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
17 sitesSweden
Study dates
4 Jul 2018to 1 Jun 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 52 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of Relapsing Remitting MS according to the 2017 revised McDonald criteria OR one demyelinating episode in conjunction with at least one asymptomatic high intensity T2 lesion with size and location compatible with MS
  • The patient has completed the RIFUND-MS trial and is treated with either of the study medications rituximab or DMF at the last visit of the RIFUND trial OR has been treated with rituximab with a dose regimen of 500 - 1000 mg followed by 500 mg every 6 months for up to two years as part of clinical practice
  • Age 20 - 52 years (inclusive)
  • EDSS 0 - 5,5 (inclusive)
  • The patient is willing and able to give written informed consent, according to the judgement of the investigator.
  • In fertile females, willing to comply with effective contraceptive methods. These include birth control pills, surgical sterilization of patient or partner or intrauterine device. Non-fertile women is defined as more than 12 months of amenorrhea without an alternative medical cause or, in case of ambiguities, an FSH level in the postmenopausal range.

Who cannot join

  • Diagnosis of Progressive MS
  • Previous treatment with any "second-line" immunomodulatory drug, eg natalizumab, alemtuzumab, fingolimod, or other long-acting immunosuppressive agents.
  • Pregnant or lactating women s-HCG will be tested on all women at screening, before each study-related infu-sion and in any situation where there is a reason to suspect pregnancy during the trial, e.g delayed menstrual period more than five days above expected time.
  • Patients having contraindication for or otherwise not compliant with MRI investigations
  • Simultaneous treatment with other immunosuppressive drugs
  • Active, severe infections Signs of infections are assessed before inclusion and each study-related infusion through clinical examination and further evaluated by laboratory and other relevant investigations in case of suspected ongoing infection. Hepatitis serology (HBsAg and anti-HBc) will be evaluated before treatment onset if not tested within the previous three years.
Show all 10Show fewer
  • Severe cardiac disorder, e.g signs of congestive heart failure or coronary artery disease. This will be evaluated through clinical assessment before inclusion.
  • Vaccination within 4 weeks of first dose of study medication.
  • Documented allergy or intolerance to the IP
  • Severe psychiatric condition

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Sweden17 sites

  • South Älvsborg Hospital

    Borås

  • Anders Svenningsson

    Danderyd, Stockholm County, 18288

  • Falun Hospital

    Falun

  • Gävle Hospital

    Gävle

  • Saghlgrenska Hospital

    Gothenburg

  • Helsingborg Hospital

    Helsingborg

  • Karlstad Hospital

    Karlstad

  • Halland Hospital Kungsbacka

    Kungsbacka

  • Linköping University Hospital

    Linköping

  • Nyköping Hospital

    Nyköping

  • Örebro University Hospital

    Örebro

  • Östersund Hospital

    Östersund

  • Capio StGöran Hospital

    Stockholm

  • Fredrik Piehl

    Stockholm

  • Karolinska Hospital Huddinge

    Stockholm

  • Umeå University

    Umeå

  • Uppsala Academiska Hospital

    Uppsala

Other trials in Sweden

About this study

Official title: RItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MS. A Randomized Trial of Long-term Dosage of Rituximab in Multiple Sclerosis

A randomized trial of long-term dosage of rituximab in multiple sclerosis

Read the detailed description

This is a prospective randomized phase 3 study comparing two dosing regimens of Rituximab in long-term treatment of MS. Primary endpoint is no evidence of disease activity (NEDA) in a non-inferiority analysis between 12-months dosing interval of 500 mg rituximab with 6-months dosing interval. The endpoint is a compound of being free from release, new or enlarging MRI lesions and sustained progression of disability measured by EDSS.

Each patient will have one treating physician responsible for all ongoing medical questions and decisions regarding continuation in the study and one examining physician performing the blinded Expanded Disability Status Scale examination and assessments of exacerbations. The coordinating nurse will administer the study-related tests and administer the rituximab infusions. MRI investigations will be performed blinded for the dosing arm allocation.

Randomization will be performed via a randomization module in the national Swedish MS registry. The patients will be randomized in a 1:1 ratio and receive their treatments in accordance with clinical practice. Thus, the study will mimic the real-life situation in which the treatments will be administered. This will lead to a high degree of validity in relation to expected outcome in clinical practice.

Being tested
Rituximab
Keywords
Multiple sclerosis, Relapsing-Remitting, Dosing protocols, Randomized trial
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Mabthera

    After one year in the trial, the patients are split in the two dosing-arms described above. The dose-comparison phase continues four years.

Study groups in NCT03979456
Study groupRoleWhat they receive
6-month dosing intervalActive comparatorThis arm is receiving standard dose rituximab 500 mg every 6 months
Receives: Drug: Rituximab
12-month dosing intervalExperimentalThis arm is receiving the comparator dose rituximab 500 mg every 12 months
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. No evidence of disease activity (NEDA)

    The proportion of patients maintaining No Evidence of Disease Activity-3 (NEDA-3) during year 2 - 4 of the trial: No relapse, no new T2 lesions (> 3 mm), no EDSS progression in either dose arm

    Measured: 3 years

Secondary outcomes (11)

  1. No evidence of disease activity (NEDA) in subgroups

    The proportion of patients maintaining NEDA-3 comparing the previous rituximab arm with the previous DMF arm from the RIFUND trial

    Measured: 4 years

  2. Time to first relapse

    Time to first relapse for the two dose arms

    Measured: 3 yeas

  3. Freedom of new or enlarged lesions on MRI

    Proportion of patients in each dosing arm without new/enlarging T2 lesions

    Measured: 3 years

  4. Development of brain atrophy

    Evolution of brain atrophy measured as brain parenchymal fraction (BPF) and corpus callosum area or -volume

    Measured: 3 years

  5. Development of confirmed sustained disability

    Proportion of patient with confirmed progression in EDSS according to pre-specified criteria

    Measured: 3 years

  6. Mean progression of disability

    The mean change in EDSS over the trial period in the two dosing arms

    Measured: 3 years

  7. Neurodegeneration

    The mean change of s-NFL concentration between the two dosing arms

    Measured: 3 years

  8. Dose persistence

    Time to discontinuation of dosing regimen allocation

    Measured: 3 years

  9. Development of hypogammaglobulinaemia

    The occurrence of hypogammaglobulinaemia in the two dosing arms

    Measured: 3 years

  10. Development of neutropenia

    The occurrence of neutropenia in the two dosing arms

    Measured: 3 years

  11. Development of infections

    The occurrence of infections in the two dosing arms

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2019
  2. Study start4 Jul 2018
  3. Primary completion20 Dec 2024 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03979456
Sponsor's protocol ID
EudraCT 2018-000721-31
Acronym
RIDOSE-MS
Status last verified
Apr 2021
First submitted
3 Jun 2019
Last updated
19 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab in people with Multiple Sclerosis, Relapsing-Remitting, run by Karolinska Institutet at 17 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

No evidence of disease activity (NEDA) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03979456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in