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Rheumatoid ArthritisPhase 1NCT06175338

Study, Evaluating Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety Profiles of Rituximab Compared to MabThera® in Patients With Rheumatoid Arthritis

A Phase 1 study testing Rituximab and MabThera® in people with Rheumatoid Arthritis, run by Mabscale, LLC at 12 sites in Russia.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

A randomised, double blind, parallel group, multicentre study to compare the pharmacokinetics, pharmacodynamics, immunogenicity and safety of Rituximab (Mabscale LLC, Russia) versus MabThera® in patients with rheumatoid arthritis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Rituximab and MabThera®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
12 sitesRussia
Study dates
14 Jun 2023to Apr 2025
Phase
Phase 1
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and Female 18-65 y.o. with body weight 50-120 kg
  • Patients with active rheumatoid arthritis with disease duration minimum 6 months prior to screening visit per ACR/EULAR 2019 criteria classification.
  • Moderate or severe active course of rheumatoid arthritis, which is defined as the fulfillment of all of the following conditions:
  • ≥6 tender joints (based on a score of 68 joints) at screening and baseline; And
  • ≥6 swollen joints (based on a score of 66 joints) at screening and at baseline; And
  • level of C-reactive protein is not less than 10 mg/l or ESR is not less than 28 mm/hour at screening.
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  • Positive result of the analysis for antibodies to cyclic citrullinated peptide (≥10 units/ml) and / or the presence of rheumatoid factor (≥ 20 units/ml) at screening (see section).
  • Received treatment for RA and experienced an inadequate response or intolerance to treatment with at least 1 anti-TNF alpha therapy;
  • Must have received MTX for a minimum of 12 weeks, with the last 4 weeks, prior to screening at a stable dose 10-25 mg/week;

Who cannot join

  • Contraindications according to the MabThera SmPC and every serious coexisting diseases which, in the Investigator's opinion, would preclude subject participation
  • History of current rheumatic autoimmune disease other than RA and current inflammatory joint disease other than RA
  • Positive tests for HIV, hepatitis B surface antigen (HBsAg) Anti-HBc antibody, hepatitis C antibody
  • Prior treatment with rituximab, other anti-CD20 mAb
  • Pregnancy or lactation or women planning to get pregnant during the course of the study and/or within 12 months post last study drug infusion
  • COVID prior 8 weeks prior to Screening visit or other acute systemic infection within 4 weeks prior to Day 1
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  • Allergic reaction or intolerance to rituximab, MabionCD20 or any of their components
  • Severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or previous treatment of any lymphocyte-depleting therapies
  • Confirmed current active tuberculosis (TB).
  • Any significant cardiac disease
  • History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the study drug including known hypersensitivity or allergy to a murine product.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Russia12 sites

  • Immanuel Kant Baltic Federal University

    Kaliningrad

  • Scientific-Research Medical Complex Your Health

    Kazan'

  • LLC "Medical Center Revma-Med"

    Kemerovo

  • LLC "Korolev Family Clinic №4"

    Korolyov

  • Moscow City Clinical Hospital №1

    Moscow

  • V.A. Nasonova Research Institute of Rheumatology

    Moscow

  • Orenburg State Medical University

    Orenburg

  • JSC "Northwestern Center for Evidence-Based Medicine"

    Saint Petersburg

  • LLC "Interleukin"

    Saint Petersburg

  • Medical center "Capital-Polis"

    Saint Petersburg

  • Saratov State Medical University

    Saratov

  • LLC "Biomed"

    Vladimir

Other trials in Russia

About this study

Official title: Randomized Double Blind Phase I Trial Comparing Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Rituximab (Mabscale LLC, Russia)+ Methotrexate+ Folic Acid and MabThera® Methotrexate+ Folic Acid in Adult Patients With Moderate or Severe Rheumatoid Arthritis With Insufficient Response to Treatment Tumor Necrosis Factor (TNF-α)

A randomised, double blind, parallel group, multicentre study to compare the pharmacokinetics, pharmacodynamics, immunogenicity and safety of Rituximab (Mabscale LLC, Russia) versus MabThera® in patients with rheumatoid arthritis.

Read the detailed description

RIT-1/01092021 is a double-blind randomized, parallel group, multicenter clinical trial comparing pharmacokinetics, pharmacodynamics, immunogenicity and safety of Rituximab (Mabscale LLC, Russia) and MabThera® in adult patients with moderate or severe rheumatoid arthritis with insufficient response to treatment tumor necrosis factor (TNF-α) inhibitors receiving background treatment with methotrexate. The purpose of the study is to demonstrate equivalence of pharmacokinetics, pharmacodynamics, immunogenicity and safety of Rituximab (Mabscale LLC, Russia) and MabThera®. The study will take place across approximately 30 study sites in Russia in order to randomize 208 patients. Rituximab is a monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to MabThera®, which is approved as treatment in case of insufficient response or toxicity to treatment tumor necrosis factor (TNF-α) inhibitors receiving background treatment with methotrexate. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.

Being tested
Rituximab, MabThera®
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • RituximabDrug

    Rituximab 1000 mg in 150 ml 0,9 % NaCl (total volume of infusion 250 ml)

  • MabThera®Drug

    MabThera® 1000 mg in 150 ml 0,9 % NaCl (total volume of infusion 250 ml)

Study groups in NCT06175338
Study groupRoleWhat they receive
Rituximab (manufactured by Mabscale, LLC)ExperimentalEligible subjects (104 patients) will receive Rituximab 1000 mg in 150 ml 0,9 % NaCl (total volume of infusion 250 ml) twice: on Visit 1 and 5. The following visits are the visits of safety and PK, PD and immunogenicity and also preliminary effectiveness). Patients will also receive background treatment Methotrexate+ Folic acid.
Receives: Drug: Rituximab
MabThera®Active comparatorEligible subjects (104 patients) will receive MabThera® 1000 mg in 150 ml 0,9 % NaCl (total volume of infusion 250 ml) twice: on Visit 1 and 5. The following visits are the visits of safety and PK, PD and immunogenicity and also preliminary effectiveness). Patients will also receive background treatment Methotrexate+ Folic acid.
Receives: Drug: MabThera®

What is being measured

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

  1. AUC(w2-24)

    Area Under the Concentration Time Curve predose Day 1 to Week 24 (AUC(w2-24).

    Measured: Day 1 to Week 24

  2. AUC0-inf

    Area Under the Concentration Time Curve extrapolated from 0 to infinity (AUC0-inf)

    Measured: Day 1 to Week 24

  3. Cmax

    Maximum Plasma Concentration (Cmax) after Dose 2

    Measured: Dose 2 to the end of the study or Week 24

Secondary outcomes (4)

  1. Ctrough

    Residual concentration (Ctrough) before the second infusion on Day 15

    Measured: Day 1 to Day 15

  2. AUC0-d15

    Area under the concentration-time curve from 0 (directly pre-infusion on Day 1) before pre-infusion measurement on Day 15 (AUC0-d15)

    Measured: Day 1 - Day 15 (before infusion)

  3. AUC0-w12

    Area under the concentration-time curve from 0 and before measurement at Week 12 (AUC0-w12)

    Measured: Day 1 - Week 12 (before infusion)

  4. AUCd15-n24

    Area under the concentration-time curve from measurement immediately before the second infusion (Day 15) before measuring in point Week 24 (AUCd15-n24)

    Measured: Day 15 - Week 24

Timeline

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

  1. First posted18 Dec 2023
  2. Study start14 Jun 2023
  3. Primary completionNov 2024 (estimated)
  4. Study completionApr 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 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06175338
Sponsor's protocol ID
RIT-1/01092021
Status last verified
Sep 2024
First submitted
7 Dec 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rituximab and MabThera® in people with Rheumatoid Arthritis, run by Mabscale, LLC at 12 sites in Russia.

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 9 inclusion and 11 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 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Russia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

AUC(w2-24) (time frame: Day 1 to Week 24). The study lists 3 primary outcomes in all. 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 NCT06175338.

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 Sep 2024.

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