ADAs to Alemtuzumab
A Study of a New Assay to Detect Anti-drug Antibodies to Alemtuzumab and Their Potential Impact in Multiple Sclerosis
1 other identifier
observational
15
1 country
1
Brief Summary
The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2022
CompletedFirst Submitted
Initial submission to the registry
March 7, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2025
CompletedMarch 2, 2026
February 1, 2026
3.3 years
March 7, 2024
February 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To quantify the longitudinal changes in alemtuzumab ADAs
2 years
Secondary Outcomes (5)
1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.
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.
2 years
3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.
2 years
4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels
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.
2 years
Interventions
Licensed dose
Eligibility Criteria
Relapsing-remitting MS
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barts Health NHS Trust
London, Second Floor Neurophys Dept, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2024
First Posted
March 15, 2024
Study Start
July 12, 2022
Primary Completion
October 17, 2025
Study Completion
October 17, 2025
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share