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

NCT03979456 | Unknown Phase 3 DMC

• 1 other identifier: EudraCT 2018-000721-31
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple sclerosis; Relapsing-Remitting; Dosing protocols; Randomized trial

Outcome Measures

Primary Outcomes (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

  3 years

Secondary Outcomes (11)

• No evidence of disease activity (NEDA) in subgroups

  4 years

• Time to first relapse

  3 yeas

• Freedom of new or enlarged lesions on MRI

  3 years

• Development of brain atrophy

  3 years

• Development of confirmed sustained disability

  3 years

Other Outcomes (2)

• Health economy

  3 years

• Treatment Satisfaction Questionnaire

  3 years

Study Arms (2)

6-month dosing interval

ACTIVE COMPARATOR

This arm is receiving standard dose rituximab 500 mg every 6 months

Drug: Rituximab

12-month dosing interval

EXPERIMENTAL

This arm is receiving the comparator dose rituximab 500 mg every 12 months

Drug: Rituximab

Interventions

Rituximab DRUG

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

Also known as: Mabthera

12-month dosing interval; 6-month dosing interval

Eligibility Criteria

• Age: 20 Years - 52 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Vaccination within 4 weeks of first dose of study medication.
• Documented allergy or intolerance to the IP
• Severe psychiatric condition

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (17)

Anders Svenningsson

Danderyd, Stockholm County, 18288, Sweden

Location

South Älvsborg Hospital

Borås, Sweden

Location

Falun Hospital

Falun, Sweden

Location

Gävle Hospital

Gävle, Sweden

Location

Saghlgrenska Hospital

Gothenburg, Sweden

Location

Helsingborg Hospital

Helsingborg, Sweden

Location

Karlstad Hospital

Karlstad, Sweden

Location

Halland Hospital Kungsbacka

Kungsbacka, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Nyköping Hospital

Nyköping, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Östersund Hospital

Östersund, Sweden

Location

Capio StGöran Hospital

Stockholm, Sweden

Location

Fredrik Piehl

Stockholm, Sweden

Location

Karolinska Hospital Huddinge

Stockholm, Sweden

Location

Umeå University

Umeå, Sweden

Location

Uppsala Academiska Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Anders Svenningsson, Professor

  Dept of Clinical Sciences, Karolinska Institutet Danderyd Hospital, Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 7, 2019
• Study Start: July 4, 2018
• Primary Completion: December 20, 2024
• Study Completion: June 1, 2025
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

SE (17)