MSFrontier

ADAs to Alemtuzumab

Impact of Anti-drug Antibodies to Alemtuzumab in Multiple Sclerosis
CompletedRelapsing MSNCT06310343

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 12 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • To quantify the longitudinal changes in alemtuzumab ADAs

    2 years

Other measures (5)

  • 1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.

    1 year

    Immune responseSafety

  • 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

    Immune responseSafety

  • 3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.

    2 years

    Disability progressionRelapsesImmune response

  • 4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels

    2 years

    Disability progressionRelapsesImmune response

  • 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

    MRI lesionsBlood or spinal fluid markersImmune response

Who could take part

Relapsing MS · 18 to 55

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).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

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History

    1. Started

      Jul 2022

    2. Main results due

      Oct 2025

    3. Finished

      Oct 2025

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