ID

44708

Description

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential; ODM derived from: https://clinicaltrials.gov/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany

Lien

https://clinicaltrials.gov/show/NCT02419378

Mots-clés

Versions (4)
  1. 18/08/2015 18/08/2015 - Martin Dugas
  2. 22/05/2016 22/05/2016 -
  3. 28/05/2016 28/05/2016 -
  4. 27/09/2021 27/09/2021 -
Téléchargé le

27 septembre 2021

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

Anglais

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. signed informed consent form (icf)
Description

signed informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
2. age 18 to 55 years old (inclusive) as of the date the icf is signed
Description

2. age 18 to 55 years old (inclusive) as of the date the icf is signed

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before screening
Description

3. diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before screening

Type de données

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0917711
4. onset of ms symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the icf is signed
Description

4. onset of ms symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the icf is signed

Type de données

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0040223
5. edss score 0.0 to 4.0 (inclusive) at screening
Description

5. edss score 0.0 to 4.0 (inclusive) at screening

Type de données

boolean

Alias
UMLS CUI [1]
C0451246
6. ≥2 ms relapses within 24 months or clinical (≥1 relapse) or mri (new gadolinium enhancing lesions) disease activity under therapy with interferon beta, glatirameracetate, natalizumab or fingolimod
Description

6. ≥2 ms relapses within 24 months or clinical (≥1 relapse) or mri (new gadolinium enhancing lesions) disease activity under therapy with interferon beta, glatirameracetate, natalizumab or fingolimod

Type de données

boolean

Alias
UMLS CUI [1]
C2707252
7. indicated to receive alemtuzumab according to the investigator's assessment
Description

7. indicated to receive alemtuzumab according to the investigator's assessment

Type de données

boolean

Alias
UMLS CUI [1,1]
C1548948
8. completion of all vaccinations required by the applicable immunization guidelines published by "ständige impfkommission" (stiko)
Description

8. completion of all vaccinations required by the applicable immunization guidelines published by "ständige impfkommission" (stiko)

Type de données

boolean

Alias
UMLS CUI [1]
C0042196
9. history of chickenpox or positive test for antibodies against varicella zoster virus (vzv)
Description

9. history of chickenpox or positive test for antibodies against varicella zoster virus (vzv)

Type de données

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [2]
C0042338
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. participation in another clinical trial at present or within 4 weeks of study entry. there may be exceptions at the discretion of the investigator.
Description

1. participation in another clinical trial at present or within 4 weeks of study entry. there may be exceptions at the discretion of the investigator.

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
2. has any progressive form of ms
Description

2. has any progressive form of ms

Type de données

boolean

Alias
UMLS CUI [1]
C0393665
3. hypersensitivity to the active substance, or to any of the excipients of lemtrada
Description

3. hypersensitivity to the active substance, or to any of the excipients of lemtrada

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1372955
4. medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
Description

4. medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [2,1]
C0525058
5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms
Description

5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms

Type de données

boolean

Alias
UMLS CUI [1]
C0231170
6. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage
Description

6. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage

Type de données

boolean

Alias
UMLS CUI [1]
C0442893
7. known bleeding disorder (e.g,. dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation (dic), fibrinogen deficiency, or clotting factor deficiency)
Description

7. known bleeding disorder (e.g,. dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation (dic), fibrinogen deficiency, or clotting factor deficiency)

Type de données

boolean

Alias
UMLS CUI [1]
C3251812
8. significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
Description

8. significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004364
9. history of malignancy, except basal skin cell carcinoma
Description

9. history of malignancy, except basal skin cell carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
10. major psychiatric disorder that is not adequately controlled by treatment
Description

10. major psychiatric disorder that is not adequately controlled by treatment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
11. epileptic seizures that are not adequately controlled by treatment
Description

11. epileptic seizures that are not adequately controlled by treatment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation
Description

12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
13. in the investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)
Description

13. in the investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)

Type de données

boolean

Alias
UMLS CUI [1,1]
C0582147
14. seropositivity for human immunodeficiency virus (hiv)
Description

14. seropositivity for human immunodeficiency virus (hiv)

Type de données

boolean

Alias
UMLS CUI [1]
C0019699
15. infection with hepatitis c virus
Description

15. infection with hepatitis c virus

Type de données

boolean

Alias
UMLS CUI [1]
C0019196
16. past or present hepatitis b infection (positive hepatitis b serology)
Description

16. past or present hepatitis b infection (positive hepatitis b serology)

Type de données

boolean

Alias
UMLS CUI [1]
C0019163
17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)
Description

17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)

Type de données

boolean

Alias
UMLS CUI [1]
C0010825
UMLS CUI [2]
C0014644
UMLS CUI [3]
C0042338
18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
Description

18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.

Type de données

boolean

Alias
UMLS CUI [1]
C0041296
19. invasive fungal infections in history and at present
Description

19. invasive fungal infections in history and at present

Type de données

boolean

Alias
UMLS CUI [1]
C0026946
20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity
Description

20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0856201
21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication
Description

21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication

Type de données

boolean

Alias
UMLS CUI [1]
C3843746
22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening
Description

22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening

Type de données

boolean

Alias
UMLS CUI [1]
C1855068
23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening
Description

23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening

Type de données

boolean

Alias
UMLS CUI [1]
C3810110
24. b-cell count (absolute cd19+) <lln at screening
Description

24. b-cell count (absolute cd19+) <lln at screening

Type de données

boolean

Alias
UMLS CUI [1,1]
C3540683
UMLS CUI [1,2]
C0205216
25. absolute neutrophil count <lln at screening
Description

25. absolute neutrophil count <lln at screening

Type de données

boolean

Alias
UMLS CUI [1]
C1168174
26. confirmed platelet count < the lln of the evaluating laboratory at screening or documented at <100,000/μl within the past year on a sample without platelet clumping
Description

26. confirmed platelet count < the lln of the evaluating laboratory at screening or documented at <100,000/μl within the past year on a sample without platelet clumping

Type de données

boolean

Alias
UMLS CUI [1]
C0040034
27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)
Description

27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)

Type de données

boolean

Alias
UMLS CUI [1,1]
C0370061
UMLS CUI [1,2]
C0076635
28. any hepatic or renal function value grade 2 or higher at screening, with the exception of hyperbilirubinemia due to gilbert's syndrome. see table below, drawn from the national cancer institute (nci) common terminology criteria for adverse events v4.0 (ctcae), published 28 may 2009.
Description

28. any hepatic or renal function value grade 2 or higher at screening, with the exception of hyperbilirubinemia due to gilbert's syndrome. see table below, drawn from the national cancer institute (nci) common terminology criteria for adverse events v4.0 (ctcae), published 28 may 2009.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0151746
UMLS CUI [2,1]
C0086565
bilirubin >1.5 × uln
Description

bilirubin >1.5 × uln

Type de données

boolean

Alias
UMLS CUI [1]
C0201913
sgot/ast >3.0 × uln
Description

sgot/ast >3.0 × uln

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
sgpt/alt >3.0 × uln
Description

sgpt/alt >3.0 × uln

Type de données

boolean

Alias
UMLS CUI [1]
C0201836
alkaline phosphatase >2.5 × uln
Description

alkaline phosphatase >2.5 × uln

Type de données

boolean

Alias
UMLS CUI [1]
C0201850
creatinine > 1.5 × uln
Description

creatinine > 1.5 × uln

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
29. vaccination less than 6 weeks prior to study inclusion.
Description

29. vaccination less than 6 weeks prior to study inclusion.

Type de données

boolean

Alias
UMLS CUI [1]
C0042196
30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion
Description

30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [2,1]
C0499076
31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis
Description

31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0749014
32. inability to undergo mri with gadolinium administration
Description

32. inability to undergo mri with gadolinium administration

Type de données

boolean

Alias
UMLS CUI [1]
C0024485
33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating
Description

33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating

Type de données

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
34. female patients of childbearing potential: unwilling to agree to use a reliable and acceptable contraceptive method (pearl index <1) throughout the study period. these methods include: hormone releasing intrauterine device (iud), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).
Description

34. female patients of childbearing potential: unwilling to agree to use a reliable and acceptable contraceptive method (pearl index <1) throughout the study period. these methods include: hormone releasing intrauterine device (iud), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).

Type de données

boolean

Alias
UMLS CUI [1,1]
C0700589
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Similar models

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
signed informed consent
Item
1. signed informed consent form (icf)
boolean
C0021430 (UMLS CUI [1])
age
Item
2. age 18 to 55 years old (inclusive) as of the date the icf is signed
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis; McDonald criteria and MRI Scan
Item
3. diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before screening
boolean
C0026769 (UMLS CUI [1,1])
C0917711 (UMLS CUI [1,2])
Onset of symptoms within 5 years
Item
4. onset of ms symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the icf is signed
boolean
C1457887 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
EDSS score
Item
5. edss score 0.0 to 4.0 (inclusive) at screening
boolean
C0451246 (UMLS CUI [1])
Active disease
Item
6. ≥2 ms relapses within 24 months or clinical (≥1 relapse) or mri (new gadolinium enhancing lesions) disease activity under therapy with interferon beta, glatirameracetate, natalizumab or fingolimod
boolean
C2707252 (UMLS CUI [1])
Medical Judgment
Item
7. indicated to receive alemtuzumab according to the investigator's assessment
boolean
C1548948 (UMLS CUI [1,1])
Vaccinations
Item
8. completion of all vaccinations required by the applicable immunization guidelines published by "ständige impfkommission" (stiko)
boolean
C0042196 (UMLS CUI [1])
Chickenpox; VZV
Item
9. history of chickenpox or positive test for antibodies against varicella zoster virus (vzv)
boolean
C0008049 (UMLS CUI [1,1])
C0042338 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Other trial
Item
1. participation in another clinical trial at present or within 4 weeks of study entry. there may be exceptions at the discretion of the investigator.
boolean
C2348568 (UMLS CUI [1])
Progressive Multiple Sclerosis
Item
2. has any progressive form of ms
boolean
C0393665 (UMLS CUI [1])
Hypersensitivity to active substance
Item
3. hypersensitivity to the active substance, or to any of the excipients of lemtrada
boolean
C0020517 (UMLS CUI [1,1])
C1372955 (UMLS CUI [1,2])
Informed Consent | Protocol Compliance
Item
4. medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
boolean
C0021430 (UMLS CUI [1,1])
C0525058 (UMLS CUI [2,1])
Disability
Item
5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms
boolean
C0231170 (UMLS CUI [1])
Major disease
Item
6. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage
boolean
C0442893 (UMLS CUI [1])
Bleeding disorder
Item
7. known bleeding disorder (e.g,. dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation (dic), fibrinogen deficiency, or clotting factor deficiency)
boolean
C3251812 (UMLS CUI [1])
Autoimmune Diseases
Item
8. significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
boolean
C0004364 (UMLS CUI [1,1])
malignancy, except basal skin cell carcinoma
Item
9. history of malignancy, except basal skin cell carcinoma
boolean
C0006826 (UMLS CUI [1])
Psychiatric disorder, uncontrolled
Item
10. major psychiatric disorder that is not adequately controlled by treatment
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Seizures, uncontrolled
Item
11. epileptic seizures that are not adequately controlled by treatment
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Active infection
Item
12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation
boolean
C0009450 (UMLS CUI [1])
high risk of infection
Item
13. in the investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)
boolean
C0582147 (UMLS CUI [1,1])
HIV positive
Item
14. seropositivity for human immunodeficiency virus (hiv)
boolean
C0019699 (UMLS CUI [1])
Hepatitis C
Item
15. infection with hepatitis c virus
boolean
C0019196 (UMLS CUI [1])
hepatitis b
Item
16. past or present hepatitis b infection (positive hepatitis b serology)
boolean
C0019163 (UMLS CUI [1])
CMV | EBV | VZV infection
Item
17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)
boolean
C0010825 (UMLS CUI [1])
C0014644 (UMLS CUI [2])
C0042338 (UMLS CUI [3])
Tuberculosis
Item
18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
boolean
C0041296 (UMLS CUI [1])
Fungal infection
Item
19. invasive fungal infections in history and at present
boolean
C0026946 (UMLS CUI [1])
Cervical cytology
Item
20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity
boolean
C0856201 (UMLS CUI [1,1])
other illness
Item
21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication
boolean
C3843746 (UMLS CUI [1])
CD4+ low
Item
22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening
boolean
C1855068 (UMLS CUI [1])
CD8+ low
Item
23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening
boolean
C3810110 (UMLS CUI [1])
CD19+ low
Item
24. b-cell count (absolute cd19+) <lln at screening
boolean
C3540683 (UMLS CUI [1,1])
C0205216 (UMLS CUI [1,2])
ANC low
Item
25. absolute neutrophil count <lln at screening
boolean
C1168174 (UMLS CUI [1])
Thrombopenia
Item
26. confirmed platelet count < the lln of the evaluating laboratory at screening or documented at <100,000/μl within the past year on a sample without platelet clumping
boolean
C0040034 (UMLS CUI [1])
Anti-thyrotropin antibody | Thyroid peroxidase antibody
Item
27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)
boolean
C0370061 (UMLS CUI [1,1])
C0076635 (UMLS CUI [1,2])
Abnormal renal function | abnormal hepatic function
Item
28. any hepatic or renal function value grade 2 or higher at screening, with the exception of hyperbilirubinemia due to gilbert's syndrome. see table below, drawn from the national cancer institute (nci) common terminology criteria for adverse events v4.0 (ctcae), published 28 may 2009.
boolean
C0151746 (UMLS CUI [1,1])
C0086565 (UMLS CUI [2,1])
Bilirubin, total
Item
bilirubin >1.5 × uln
boolean
C0201913 (UMLS CUI [1])
AST
Item
sgot/ast >3.0 × uln
boolean
C0201899 (UMLS CUI [1])
ALT
Item
sgpt/alt >3.0 × uln
boolean
C0201836 (UMLS CUI [1])
Alkaline phosphatase
Item
alkaline phosphatase >2.5 × uln
boolean
C0201850 (UMLS CUI [1])
Creatinine
Item
creatinine > 1.5 × uln
boolean
C0201976 (UMLS CUI [1])
vaccination
Item
29. vaccination less than 6 weeks prior to study inclusion.
boolean
C0042196 (UMLS CUI [1])
Antineoplastic drug | Immunosuppressive drug
Item
30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion
boolean
C0003392 (UMLS CUI [1,1])
C0499076 (UMLS CUI [2,1])
Steroid intolerance
Item
31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis
boolean
C0749014 (UMLS CUI [1,1])
MRI
Item
32. inability to undergo mri with gadolinium administration
boolean
C0024485 (UMLS CUI [1])
pregnant | lactating
Item
33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
Contraception
Item
34. female patients of childbearing potential: unwilling to agree to use a reliable and acceptable contraceptive method (pearl index <1) throughout the study period. these methods include: hormone releasing intrauterine device (iud), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).
boolean
C0700589 (UMLS CUI [1,1])
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