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CompletedNCT06310343Updated Mar 2, 2026

ADAs to Alemtuzumab

An observational study in Multiple Sclerosis, sponsored by Queen Mary University of London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by Queen Mary University of London · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period

Read the detailed description

Primary To quantify the longitudinal changes in alemtuzumab ADAs over a 24 month period.

Secondary

  1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.
  2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions.
  3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.
  4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels.
  5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity.
02

Conditions studied

  • Multiple Sclerosis

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03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 15 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Relapsing-remitting MS

Inclusion criteria

  1. Patients with RRMS who are being treated with alemtuzumab at Barts Health NHS Trust will be approached to participate in the study.
  2. Patients must be willing and able to undergo blood tests.

Exclusion criteria

Exclusion Criteria:

  1. Ineligible for alemtuzumab under NHS England prescribing guidelines.
  2. Those unable to comply with study requirements, including frequency of visits. Abnormal baseline investigations (WBC\<3 x 10*9/l, lymphocytes \<1.0 x 10*9/l, neutrophil count \<1.5 x 10*9/l, platelet count \<100 x 10*9/l, haemoglobin \<110 g/l, LFT >/3x upper limit of normal of site reference ranges, potassium \<2.8 mmol/l or >5.5 mmol/l, sodium /,125 mmol/l, creatinine >130 umol/l).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Interventions

  • DrugAlemtuzumab

    Licensed dose

06

What researchers measure

Primary outcomes

  1. To quantify the longitudinal changes in alemtuzumab ADAs

    Time frame: 2 years

Secondary outcomes

  1. 1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.

    Time frame: 1 year

  2. 2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions.

    Time frame: 2 years

  3. 3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.

    Time frame: 2 years

  4. 4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels

    Time frame: 2 years

  5. 5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity.

    Time frame: 2 years

07

Study locations

1 site
  • Barts Health NHS Trust
    London, Second Floor Neurophys Dept, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06310343
Lead sponsor
Queen Mary University of London
Responsible party
Sponsor
First posted
Mar 15, 2024
Start date
Jul 12, 2022
Primary completion
Oct 17, 2025
Completion
Oct 17, 2025
Last update
Mar 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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