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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alemtuzumab | Drug | Licensed dose |
| Measure | Description | Time Frame |
|---|---|---|
| To quantify the longitudinal changes in alemtuzumab ADAs | 2 years |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Relapsing-remitting MS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Health NHS Trust | London | Second Floor Neurophys Dept | United Kingdom |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |