Clinical trial NCT06310343: ADAs to Alemtuzumab
Official title: A Study of a New Assay to Detect Anti-drug Antibodies to Alemtuzumab and Their Potential Impact in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relapsing-remitting MS

Brief summary: 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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: To quantify the longitudinal changes in alemtuzumab ADAs
timeFrame: 2 years
Secondary outcomes:
measure: 1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.
timeFrame: 1 year
measure: 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.
timeFrame: 2 years
measure: 3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.
timeFrame: 2 years
measure: 4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
state: Second Floor Neurophys Dept
Study officials:
References: