ID

19135

Description

A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.; ODM derived from: https://clinicaltrials.gov/show/NCT00203073

Lien

https://clinicaltrials.gov/show/NCT00203073

Mots-clés

Versions (1)
  1. 07/12/2016 07/12/2016 -
Téléchargé le

7 décembre 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Relapsing Remitting Multiple Sclerosis NCT00203073

Anglais

Eligibility Relapsing Remitting Multiple Sclerosis NCT00203073

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. definite ms as determined by the mcdonald criteria (ann neurol, july 2001) with a relapsing disease course.
Description

Multiple Sclerosis, Relapsing-Remitting

Type de données

boolean

Alias
UMLS CUI [1]
C0751967
2. 2.edss 0.0 - 6.5 inclusive
Description

EDSS

Type de données

boolean

Alias
UMLS CUI [1]
C0451246
3. 18 to 55 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
4. 1 or more t1 gadolinium-enhancing lesions but no more than 15 lesions
Description

Gadolinium-Enhancing Lesion Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1333400
UMLS CUI [1,2]
C1265611
5. able and willing to sign and date an informed consent form
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients ever treated with glatiramer acetate or mitoxantrone.
Description

glatiramer acetate | Mitoxantrone

Type de données

boolean

Alias
UMLS CUI [1]
C0289884
UMLS CUI [2]
C0026259
2. patients treated with interferons or iv immunoglobulins (iv ig) in the previous 4 weeks prior to screening visits.
Description

Interferons | Immunoglobulins, Intravenous

Type de données

boolean

Alias
UMLS CUI [1]
C0021747
UMLS CUI [2]
C0085297
3. patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.
Description

Methotrexate | Azathioprine

Type de données

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0004482
4. patients ever treated with cyclophosphamide or total lymphoid irradiation (tli), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
Description

Cyclophosphamide | Lymphatic Irradiation Total | cladribine injection | Anthraquinones | Anthracyclines | Radiotherapy to mediastinum

Type de données

boolean

Alias
UMLS CUI [1]
C0010583
UMLS CUI [2,1]
C0024230
UMLS CUI [2,2]
C0439810
UMLS CUI [3]
C2075283
UMLS CUI [4]
C0003174
UMLS CUI [5]
C0282564
UMLS CUI [6]
C4049191
5. patients treated with intravenous or oral steroids within 28 days prior to initial mri.
Description

Intravenous steroids | Steroids Oral | MRI

Type de données

boolean

Alias
UMLS CUI [1]
C0563322
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0024485
6. female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator.
Description

Pregnancy | Breast Feeding | Gender Pregnancy test negative | Gender Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
7. male patients and their partners must use contraceptive methods deemed reliable by the investigator
Description

Gender Contraceptive methods | Partner Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0700589
8. lvef < 50%
Description

Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
9. patients using catheters or foley catheters
Description

Catheter Use of | Foley catheter Use of

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085590
UMLS CUI [1,2]
C1524063
UMLS CUI [2,1]
C0179804
UMLS CUI [2,2]
C1524063
10. patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: als, cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome (i.e., due to heredodegeneration), b12/folate deficiency, lyme disease, htlv 1-myelopathy
Description

Systemic disease Significant Interferes with research results | Amyotrophic Lateral Sclerosis | Cervical spondylosis with myelopathy | Syphilis | Arteritis | Cerebellar Diseases | Vitamin B 12 Deficiency | Folic Acid Deficiency | Lyme Disease | Tropical Spastic Paraparesis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0683954
UMLS CUI [2]
C0002736
UMLS CUI [3]
C0158242
UMLS CUI [4]
C0039128
UMLS CUI [5]
C0003860
UMLS CUI [6]
C0007760
UMLS CUI [7]
C0042847
UMLS CUI [8]
C0016412
UMLS CUI [9]
C0024198
UMLS CUI [10]
C0030481
11. patients with immune deficiency or other medical condition that would preclude treatment with mitoxantrone or glatiramer acetate
Description

Immunologic Deficiency Syndromes Exclude Mitoxantrone | Immunologic Deficiency Syndromes Exclude glatiramer acetate | Medical condition Excludes Mitoxantrone | Medical condition Excludes glatiramer acetate

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0026259
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0289884
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0026259
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0289884
12. abnormal screening blood tests exceeding any of the limits defined below:
Description

Blood test abnormal

Type de données

boolean

Alias
UMLS CUI [1]
C0854146
alanine transaminase (alt) - twice the upper limit of normal aspartate transaminase (ast) - twice the upper limit of normal total white blood cell count < 2.3 x 103/ul baseline neutrophil counts of < 1.5 x103/ul platelet count < 80 x 103/ul creatinine >1.5 mg/dl prothrombin time greater than 150% upper limit of normal
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Prothrombin time increased

Type de données

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0200633
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0151872
13. patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
Description

Medical condition Study Subject Participation Status Exclusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
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Similar models

Eligibility Relapsing Remitting Multiple Sclerosis NCT00203073

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
1. definite ms as determined by the mcdonald criteria (ann neurol, july 2001) with a relapsing disease course.
boolean
C0751967 (UMLS CUI [1])
EDSS
Item
2. 2.edss 0.0 - 6.5 inclusive
boolean
C0451246 (UMLS CUI [1])
Age
Item
3. 18 to 55 years of age
boolean
C0001779 (UMLS CUI [1])
Gadolinium-Enhancing Lesion Quantity
Item
4. 1 or more t1 gadolinium-enhancing lesions but no more than 15 lesions
boolean
C1333400 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Informed Consent
Item
5. able and willing to sign and date an informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
glatiramer acetate | Mitoxantrone
Item
1. patients ever treated with glatiramer acetate or mitoxantrone.
boolean
C0289884 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
Interferons | Immunoglobulins, Intravenous
Item
2. patients treated with interferons or iv immunoglobulins (iv ig) in the previous 4 weeks prior to screening visits.
boolean
C0021747 (UMLS CUI [1])
C0085297 (UMLS CUI [2])
Methotrexate | Azathioprine
Item
3. patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.
boolean
C0025677 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
Cyclophosphamide | Lymphatic Irradiation Total | cladribine injection | Anthraquinones | Anthracyclines | Radiotherapy to mediastinum
Item
4. patients ever treated with cyclophosphamide or total lymphoid irradiation (tli), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
boolean
C0010583 (UMLS CUI [1])
C0024230 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C2075283 (UMLS CUI [3])
C0003174 (UMLS CUI [4])
C0282564 (UMLS CUI [5])
C4049191 (UMLS CUI [6])
Intravenous steroids | Steroids Oral | MRI
Item
5. patients treated with intravenous or oral steroids within 28 days prior to initial mri.
boolean
C0563322 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0024485 (UMLS CUI [3])
Pregnancy | Breast Feeding | Gender Pregnancy test negative | Gender Contraceptive methods
Item
6. female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Gender Contraceptive methods | Partner Contraceptive methods
Item
7. male patients and their partners must use contraceptive methods deemed reliable by the investigator
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
8. lvef < 50%
boolean
C0428772 (UMLS CUI [1])
Catheter Use of | Foley catheter Use of
Item
9. patients using catheters or foley catheters
boolean
C0085590 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0179804 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
Systemic disease Significant Interferes with research results | Amyotrophic Lateral Sclerosis | Cervical spondylosis with myelopathy | Syphilis | Arteritis | Cerebellar Diseases | Vitamin B 12 Deficiency | Folic Acid Deficiency | Lyme Disease | Tropical Spastic Paraparesis
Item
10. patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: als, cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome (i.e., due to heredodegeneration), b12/folate deficiency, lyme disease, htlv 1-myelopathy
boolean
C0442893 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0002736 (UMLS CUI [2])
C0158242 (UMLS CUI [3])
C0039128 (UMLS CUI [4])
C0003860 (UMLS CUI [5])
C0007760 (UMLS CUI [6])
C0042847 (UMLS CUI [7])
C0016412 (UMLS CUI [8])
C0024198 (UMLS CUI [9])
C0030481 (UMLS CUI [10])
Immunologic Deficiency Syndromes Exclude Mitoxantrone | Immunologic Deficiency Syndromes Exclude glatiramer acetate | Medical condition Excludes Mitoxantrone | Medical condition Excludes glatiramer acetate
Item
11. patients with immune deficiency or other medical condition that would preclude treatment with mitoxantrone or glatiramer acetate
boolean
C0021051 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0026259 (UMLS CUI [1,3])
C0021051 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0289884 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0026259 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0289884 (UMLS CUI [4,3])
Blood test abnormal
Item
12. abnormal screening blood tests exceeding any of the limits defined below:
boolean
C0854146 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Prothrombin time increased
Item
alanine transaminase (alt) - twice the upper limit of normal aspartate transaminase (ast) - twice the upper limit of normal total white blood cell count < 2.3 x 103/ul baseline neutrophil counts of < 1.5 x103/ul platelet count < 80 x 103/ul creatinine >1.5 mg/dl prothrombin time greater than 150% upper limit of normal
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0200633 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0151872 (UMLS CUI [7])
Medical condition Study Subject Participation Status Exclusion
Item
13. patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
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