ADAs to Alemtuzumab

Queen Mary University of London15 enrolled

Overview

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

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

Conditions

Multiple Sclerosis

Interventions

AlemtuzumabDRUG

Licensed dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Barts Health NHS Trust

London, Second Floor Neurophys Dept, United Kingdom

Outcomes

Primary Outcomes

To quantify the longitudinal changes in alemtuzumab ADAs

Time frame: 2 years

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

Data from ClinicalTrials.gov

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