ID

31777

Beschreibung

CLARITY Extension Study; ODM derived from: https://clinicaltrials.gov/show/NCT00641537

Link

https://clinicaltrials.gov/show/NCT00641537

Stichworte

Versionen (1)
  1. 27.09.18 27.09.18 -
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See clinicaltrials.gov

Hochgeladen am

27. September 2018

DOI

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Eligibility Relapsing-Remitting Multiple Sclerosis NCT00641537

Englisch

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00641537

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
randomized in trial 25643 and satisfied one of the following:
Beschreibung

Randomization Clinical Trial Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
completed randomized treatment course and scheduled visits for the full 96 weeks; or
Beschreibung

Therapeutic procedure Completed | Visits Scheduled Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0008952
UMLS CUI [2,2]
C0205539
UMLS CUI [2,3]
C0205197
did not complete the randomized treatment course in trial 25643 but elected to receive rescue treatment with rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
Beschreibung

Therapeutic procedure Incomplete | Rebif | Interferon-beta | glatiramer acetate | Clinic Visits Scheduled Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205257
UMLS CUI [2]
C0752980
UMLS CUI [3]
C0015980
UMLS CUI [4]
C0289884
UMLS CUI [5,1]
C0008952
UMLS CUI [5,2]
C0205539
UMLS CUI [5,3]
C0205197
did not complete the randomized treatment course in trial 25643, declined rescue with rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
Beschreibung

Therapeutic procedure Incomplete | Rebif Rejected | Interferon-beta Rejected | Glatiramer acetate Rejected | Clinic Visits Scheduled Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205257
UMLS CUI [2,1]
C0752980
UMLS CUI [2,2]
C1548437
UMLS CUI [3,1]
C0015980
UMLS CUI [3,2]
C1548437
UMLS CUI [4,1]
C0289884
UMLS CUI [4,2]
C1548437
UMLS CUI [5,1]
C0008952
UMLS CUI [5,2]
C0205539
UMLS CUI [5,3]
C0205197
did not complete the randomized treatment course in trial 25643, were not eligible for rescue option with rebif®, and still completed scheduled clinic visits for the full 96 weeks
Beschreibung

Therapeutic procedure Incomplete | Ineligibility Rebif | Clinic Visits Scheduled Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205257
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C0752980
UMLS CUI [3,1]
C0008952
UMLS CUI [3,2]
C0205539
UMLS CUI [3,3]
C0205197
male or female, between 18 and 65 years of age (inclusive, at time of informed consent for trial 25643)
Beschreibung

Age | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
no medical history or evidence of latent tuberculosis infection (ltbi) or tuberculosis (tb), as evidenced by tb skin test or chest x-ray
Beschreibung

Latent Tuberculosis Absent TB Skin Test | Tuberculosis Absent TB Skin Test | Latent Tuberculosis Absent Chest X-ray | Tuberculosis Absent Chest X-ray

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1609538
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C3282342
UMLS CUI [2,1]
C0041296
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C3282342
UMLS CUI [3,1]
C1609538
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0039985
UMLS CUI [4,1]
C0041296
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0039985
all of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study day 1:
Beschreibung

Parameters Hematologic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0205488
hemoglobin = 11.6 to 16.2 gram per deciliter (g/dl)
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
leukocytes (total white blood cell) = 4.1 to 12.3*10^3 per microliter
Beschreibung

White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
absolute lymphocyte count (alc) = 1.02 to 3.36*10^3 per microliter
Beschreibung

Absolute lymphocyte count

Datentyp

boolean

Alias
UMLS CUI [1]
C3544087
absolute neutrophil count (anc) = 2.03 to 8.36*10^3 per microliter
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count = 140 to 450*10^3 per microliter
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
other protocol-defined inclusion/exclusion criteria may apply
Beschreibung

Eligibility Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who were not enrolled in trial 25643
Beschreibung

Enrollment Absent | Clinical Trial Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
subject has moderate to severe renal impairment
Beschreibung

Renal Insufficiency Moderate | Renal Insufficiency Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205082
use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since trial 25643
Beschreibung

Mitoxantrone | Lymphatic Irradiation Total | Myelosuppressive Therapy | Campath 1H | Cyclophosphamide | Azathioprine | Methotrexate | natalizumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0026259
UMLS CUI [2,1]
C0024230
UMLS CUI [2,2]
C0439810
UMLS CUI [3]
C1513793
UMLS CUI [4]
C1178562
UMLS CUI [5]
C0010583
UMLS CUI [6]
C0004482
UMLS CUI [7]
C0025677
UMLS CUI [8]
C1172734
use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (ivig) or plasmapheresis at any time during and since trial 25643
Beschreibung

Cytokine | Anti-cytokine therapy | Immunoglobulins, Intravenous | Plasmapheresis

Datentyp

boolean

Alias
UMLS CUI [1]
C0079189
UMLS CUI [2]
C0281178
UMLS CUI [3]
C0085297
UMLS CUI [4]
C0032134
treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before study day 1
Beschreibung

Adrenal Cortex Hormones Oral | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenocorticotropic hormone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C3653708
UMLS CUI [3]
C0001655
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Ähnliche Modelle

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00641537

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Randomization Clinical Trial Specified
Item
randomized in trial 25643 and satisfied one of the following:
boolean
C0034656 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Therapeutic procedure Completed | Visits Scheduled Completed
Item
completed randomized treatment course and scheduled visits for the full 96 weeks; or
boolean
C0087111 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0008952 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Therapeutic procedure Incomplete | Rebif | Interferon-beta | glatiramer acetate | Clinic Visits Scheduled Completed
Item
did not complete the randomized treatment course in trial 25643 but elected to receive rescue treatment with rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
boolean
C0087111 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C0752980 (UMLS CUI [2])
C0015980 (UMLS CUI [3])
C0289884 (UMLS CUI [4])
C0008952 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
C0205197 (UMLS CUI [5,3])
Therapeutic procedure Incomplete | Rebif Rejected | Interferon-beta Rejected | Glatiramer acetate Rejected | Clinic Visits Scheduled Completed
Item
did not complete the randomized treatment course in trial 25643, declined rescue with rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
boolean
C0087111 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C0752980 (UMLS CUI [2,1])
C1548437 (UMLS CUI [2,2])
C0015980 (UMLS CUI [3,1])
C1548437 (UMLS CUI [3,2])
C0289884 (UMLS CUI [4,1])
C1548437 (UMLS CUI [4,2])
C0008952 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
C0205197 (UMLS CUI [5,3])
Therapeutic procedure Incomplete | Ineligibility Rebif | Clinic Visits Scheduled Completed
Item
did not complete the randomized treatment course in trial 25643, were not eligible for rescue option with rebif®, and still completed scheduled clinic visits for the full 96 weeks
boolean
C0087111 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C1512714 (UMLS CUI [2,1])
C0752980 (UMLS CUI [2,2])
C0008952 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Age | Informed Consent
Item
male or female, between 18 and 65 years of age (inclusive, at time of informed consent for trial 25643)
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Latent Tuberculosis Absent TB Skin Test | Tuberculosis Absent TB Skin Test | Latent Tuberculosis Absent Chest X-ray | Tuberculosis Absent Chest X-ray
Item
no medical history or evidence of latent tuberculosis infection (ltbi) or tuberculosis (tb), as evidenced by tb skin test or chest x-ray
boolean
C1609538 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3282342 (UMLS CUI [1,3])
C0041296 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3282342 (UMLS CUI [2,3])
C1609538 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0039985 (UMLS CUI [3,3])
C0041296 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0039985 (UMLS CUI [4,3])
Parameters Hematologic
Item
all of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study day 1:
boolean
C0449381 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
Hemoglobin measurement
Item
hemoglobin = 11.6 to 16.2 gram per deciliter (g/dl)
boolean
C0518015 (UMLS CUI [1])
White Blood Cell Count procedure
Item
leukocytes (total white blood cell) = 4.1 to 12.3*10^3 per microliter
boolean
C0023508 (UMLS CUI [1])
Absolute lymphocyte count
Item
absolute lymphocyte count (alc) = 1.02 to 3.36*10^3 per microliter
boolean
C3544087 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) = 2.03 to 8.36*10^3 per microliter
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count = 140 to 450*10^3 per microliter
boolean
C0032181 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Enrollment Absent | Clinical Trial Specified
Item
subjects who were not enrolled in trial 25643
boolean
C1516879 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Renal Insufficiency Moderate | Renal Insufficiency Severe
Item
subject has moderate to severe renal impairment
boolean
C1565489 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Mitoxantrone | Lymphatic Irradiation Total | Myelosuppressive Therapy | Campath 1H | Cyclophosphamide | Azathioprine | Methotrexate | natalizumab
Item
use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since trial 25643
boolean
C0026259 (UMLS CUI [1])
C0024230 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C1513793 (UMLS CUI [3])
C1178562 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
C0004482 (UMLS CUI [6])
C0025677 (UMLS CUI [7])
C1172734 (UMLS CUI [8])
Cytokine | Anti-cytokine therapy | Immunoglobulins, Intravenous | Plasmapheresis
Item
use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (ivig) or plasmapheresis at any time during and since trial 25643
boolean
C0079189 (UMLS CUI [1])
C0281178 (UMLS CUI [2])
C0085297 (UMLS CUI [3])
C0032134 (UMLS CUI [4])
Adrenal Cortex Hormones Oral | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenocorticotropic hormone
Item
treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before study day 1
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2])
C0001655 (UMLS CUI [3])
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