ADAs to Alemtuzumab

A Study of a New Assay to Detect Anti-drug Antibodies to Alemtuzumab and Their Potential Impact in Multiple Sclerosis

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Alemtuzumab

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Relapsing-remitting MS

Description

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:

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To quantify the longitudinal changes in alemtuzumab ADAs	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): October 17, 2025
• Study Completion (Actual): October 17, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Alemtuzumab
• Other Study ID Numbers: 304993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No