Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Queen Mary University of London
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.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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).
