Multiple SclerosisNCT06310343
ADAs to Alemtuzumab
An observational study of Multiple Sclerosis, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Alemtuzumab
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jul 2022to 17 Oct 2025
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Relapsing-remitting MS
Who may be able to join
- Patients with RRMS who are being treated with alemtuzumab at Barts Health NHS Trust will be approached to participate in the study.
- Patients must be willing and able to undergo blood tests.
Who cannot join
- Ineligible for alemtuzumab under NHS England prescribing guidelines.
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Barts Health NHS Trust
London, Second Floor Neurophys Dept
About this study
Official title: Impact of Anti-drug Antibodies to Alemtuzumab in Multiple Sclerosis
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
- Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 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.
- Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.
- Relative change in relapses or EDSS score based on alemtuzumab ADA levels.
- 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Alemtuzumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlemtuzumabDrug
Licensed dose
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the longitudinal changes in alemtuzumab ADAs
Measured: 2 years
Secondary outcomes (5)
1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.
Measured: 1 year
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.
Measured: 2 years
3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.
Measured: 2 years
4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start12 Jul 2022
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310343
- Sponsor's protocol ID
- 304993
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anti-drug Antibodies to Alemtuzumab in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06310343
- Acronym / sponsor ID
- 304993
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period
Detailed description
Primary To quantify the longitudinal changes in alemtuzumab ADAs over a 24 month period.
Secondary
- Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 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.
- Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.
- Relative change in relapses or EDSS score based on alemtuzumab ADA levels.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Relapsing-remitting MS
Key inclusion criteria (2 listed)
- Patients with RRMS who are being treated with alemtuzumab at Barts Health NHS Trust will be approached to participate in the study.
- Patients must be willing and able to undergo blood tests.
Key exclusion criteria (2 listed)
- Ineligible for alemtuzumab under NHS England prescribing guidelines.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlemtuzumabLicensed dose | Drug | – |
Primary outcome
To quantify the longitudinal changes in alemtuzumab ADAs
Time frame: 2 years
5 secondary outcomes
1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.
Time frame: 1 year
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. 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. Relative change in relapses or EDSS score based on alemtuzumab ADA levels
Time frame: 2 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Queen Mary University of London at 1 site in United Kingdom.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To quantify the longitudinal changes in alemtuzumab ADAs (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.