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Completed

NCT Number: NCT05199571

Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China

The purpose of this study was to evaluate the efficacy and safety of ofatumumab s.c. in adult participants with relapsing multiple sclerosis (RMS) in China.

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Key information

Conditions

Relapsing Multiple Sclerosis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Lanzhou, Gansu, China

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About this study

This study consisted of three periods, Screening (up to 30 days), Treatment (12 months) and Post-treatment follow-up (6 months). It was an open-label single-arm study so all participants received the study drug. The first dose was administered in the clinic and the remaining doses were administered at home. The doses were administered at Baseline/Week 0, Week 1, Week 2, and followed by subsequent monthly dosing starting at Week 4.

Participants were required to come into the clinic for one screening visit, and 5 visits during the Treatment period for clinical evaluation and lab tests. Participants who completed the 12-month treatment had Post treatment Follow-Up visits at End of Study plus 3 months (EOS + 3M) and EOS + 6M, unless the participants decided to continue with commercially available ofatumumab treatment outside of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female Chinese aged 18-55 years (inclusive) at their enrollment of the study (signing the study consent form).
  • Clinical definite diagnosis of RMS according to the 2017 Revised McDonald criteria (Thompson et al 2018, and the documentation prior to their enrollment to the study (signing the study consent form) of:
  • Two documented relapses during the past 2 years, or
  • One documented relapse during the last year, or
  • A positive Gd-enhancing MRI scan during the year prior to Screening. Note: Screening MRI scan may be used if no positive Gd-enhancing scan exists from prior year.
  • Disability status with an EDSS score of 0 - 5.5 (inclusive) at Screening.
  • Neurologically stable within 1 month prior to both Screening and Baseline (including no MS relapse in this period).

Exclusion criteria

  • Participants with primary progressive MS (PPMS) or secondary progressive MS (SPMS) without disease activity
  • Participants meeting criteria for neuromyelitis optica spectrum disorder (NMOSD)
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential unless using effective methods of contraception while taking study treatment and for at least 6 months after stopping medication
  • Participants with an active chronic disease of the immune system other than MS
  • Participants with neurological findings consistent with PML or confirmed PML
  • Participants with active hepatitis B disease
  • Participants with active systemic infections (including but not limited to active COVID-19 infection) or known to have AIDS or to test positive for HIV antibody at Screening
  • Participants at high risk of developing or having reactivation of syphilis or tuberculosis
  • Have received any live or live-attenuated vaccines within four weeks prior to first study drug administration
  • Have been treated with medications as specified or within timeframes specified in the protocol
  • Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the participants to cooperate and comply with the study procedures.

Treatment and study plan

Ofatumumab

Biological

Solution for injection in an autoinjector (pre-filled pen) containing 20 mg ofatumumab

Other names: OMB157

Primary outcomes

  1. Adjusted Annualized Relapse Rate (ARR) Based on Confirmed Relapses

    Time frame: Baseline up to approximately 12 months

    A confirmed MS relapse is defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system).

    Adjusted ARR was obtained from fitting a negative binomial regression model adjusted for number of relapses in the previous year, baseline number of T1 Gd-enhancing lesions and baseline age as continuous covariates (offset: Natural log of time in study in years).

Secondary outcomes

  1. Number of Adverse Events and Serious Adverse Events

    Time frame: Baseline to safety cut-off up to approximately 15.2 months

    Adverse events and SAEs, including clinically significant laboratory data and vital signs which meet the definition of adverse events

  2. Number of Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan

    Time frame: Baseline up to approximately 12 months

    Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per participant) as the response variable. The model includes baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans is used as the offset.

    MRI scans were performed at screening, month 3 and 12 (end of study) and end of follow up for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement.

  3. Annualized Rate of New or Enlarging T2 Lesions

    Time frame: Baseline up to approximately 12 months

    Obtained from fitting a negative binomial regression model with log link function, the total number of new or enlarged T2 lesions (relative to baseline/month 3 scan) during the Month 3/treatment period (per participant) as the response variable. Natural log of time from screening scan in years is used as the offset. The model will include baseline age and baseline volume of T2 lesions as continuous covariates.

  4. Change in T2 Lesion Volume Relative to Baseline

    Time frame: Baseline up to approximately 12 months

    T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value

  5. Percentage Change in T2 Lesion Volume Relative to Baseline

    Time frame: Baseline up to approximately 12 months

    T2 lesion volume as measured by MRI and percent change calculated as post baseline value - baseline value divided by baseline value multiplied by 100.

Other outcomes

  1. Participant Based Annualized Relapse Rate (ARR)

    Time frame: Baseline up to approximately 12 months

    A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection.

    A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).

    Participant-based ARR was calculated by taking the total number of relapses observed for a participant divided by the total number of days in study of that participant and multiplied by 365.25.

  2. Time Based Annualized Relapse Rate (ARR)

    Time frame: Baseline up to approximately 12 months

    A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection.

    A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).

    Time-based ARR was calculated by taking the total number of relapses observed for all subjects within an age group divided by the total number of days in study of all subjects within the group and multiplied by 365.25 days.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 12-month, Open-label, Prospective, Multicenter, Interventional, Single-arm Study Assessing the Efficacy and Safety of Ofatumumab 20 mg Subcutaneous (s.c.) Injection in Relapsing Multiple Sclerosis (RMS) Patients in China

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2022
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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