Health TrialsbyHealthPanel

Ofatumumab in AQP4-IgG Seropositive NMOSD

ConditionNeuromyelitis Optica Spectrum Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTang-Du Hospital

About this trial

This is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG.

Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months.

Adults aged ≥18 years old.

Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive).

Disqualifiers

Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML.

Pregnant or breastfeeding patients and those with family planning during the study period.

Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening.

Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ofatumumab

    Drug

    The enrolled patients will receive ofatumumab (20 mg/0.4 ml) subcutaneously administered at baseline, Day 7, Day 14 and monthly thereafter. Patients will receive ofatumumab therapy for a total of 48 weeks. The first 4 infusions will be administered at study center site; subsequent infusions will be given in the patient's home with a nurse online interview to administer the infusion.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: OfatumumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in annual relapse rate (ARR) at last follow-up visit

Pre-treatment ARR was determined at baseline by the total number of attacks divided by disease course from onset to baseline; post-treatment ARR is determined at 12 months after treatment by the number of relapses divided by 12 months.

Time frame
baseline, 12 months

Secondary outcomes

1

Change from baseline in Expanded Disability Status Scale (EDSS) score

Patients are followed up and EDSS score is determined. In general, the minimum and maximum scores of EDSS are 0 and 10, respectively, with higher scores meaning a worse outcome.

Time frame
baseline, 3 months, 6 months, 9 months, 12 months
2

Change from baseline in lesion burden on MRI T2-weighted images

MRI is conducted to measure the lesion burden on T2-weighted images.

Time frame
baseline, 6 months, 12 months
3

Change from baseline in optic coherence tomography (OCT) measures

OCT is done to measure peripapillary retinal nerve fiber layer (RNFL) thickness, macular ganglion cell-inner plexiform layer (GCIPL) thickness, and macular inner nuclear layer (INL) thickness.

Time frame
baseline, 6 months, 12 months
4

Change from baseline in the frequencies of circulating B cell subsets

Circulating B cell monitoring is conducted to evaluate the effectiveness of B-cell-depletion therapy. FACS is used to measure the frequencies of CD19+ B cells, CD19+CD27+ memory B cells, and CD19+CD38+CD27+ plasmablasts.

Time frame
baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Henan Provincial People's Hospital

Collaborator

Source ClinicalTrials.gov
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