ID

31856

Beschreibung

Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA); ODM derived from: https://clinicaltrials.gov/show/NCT00753454

Link

https://clinicaltrials.gov/show/NCT00753454

Stichworte

Versionen (1)
  1. 04.10.18 04.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00753454

Englisch

Eligibility Rheumatoid Arthritis NCT00753454

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be able to understand the written informed consent form (icf)
Beschreibung

Comprehension Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0021430
patients must have achieved an acr20 (american college of rheumatology) response at week 16 and completed the entire c87077 (nct00580840) study or patients having been randomized at week 18 and having met the pre-defined criteria for flare
Beschreibung

Therapy responder Improvement Percentage | Clinical Trial Rheumatoid Arthritis Completed | Subject is Randomized | Criteria Fulfill Flare

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919876
UMLS CUI [1,2]
C2986411
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0003873
UMLS CUI [2,3]
C0205197
UMLS CUI [3]
C3815594
UMLS CUI [4,1]
C0243161
UMLS CUI [4,2]
C1550543
UMLS CUI [4,3]
C1517205
patients must have complied with the protocol requirements during their participation in c87077 (nct00580840)
Beschreibung

Protocol Compliance Clinical Trial Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
female patients of childbearing potential must have a negative urine pregnancy test at entry and must continue to have negative urine pregnancy tests throughout their study participation
Beschreibung

Childbearing Potential Urine pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
patients must be willing to comply with protocol
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have a diagnosis of any other inflammatory arthritis
Beschreibung

Arthritis Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205394
patients must not have a secondary, non-inflammatory type of arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of rheumatoid arthritis (ra)
Beschreibung

Arthritis Secondary Symptomatic Noninflammatory | Interference Evaluation Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0231220
UMLS CUI [1,4]
C0442743
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C0013230
patients must not have a history of an infected joint prosthesis with that prosthesis still in situ
Beschreibung

Prosthetic joint infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0410808
patients who do not meet the medical history exclusion criteria, as defined per protocol. examples of exclusionary criteria (not all-inclusive): pregnancy, chronic infection, active tuberculosis (tb), high risk of infection, lymphproliferative disorder, acute or chronic viral hepatitis b or c, known human immunodeficiency virus (hiv), malignancy or history of malignancy, history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
Beschreibung

Pregnancy | Chronic infectious disease | Tuberculosis | High risk of Communicable Diseases | Lymphoproliferative Disorders | Hepatitis B | Hepatitis C | Hepatitis B, Chronic | Hepatitis C, Chronic | HIV Infections | Malignant Neoplasms | Kidney Diseases Severe | Liver diseases Severe | Hematological Disease Severe | Gastrointestinal Diseases Severe | Endocrine System Diseases Severe | Lung diseases Severe | Heart Diseases Severe | Nervous system disorder Severe | Cerebral disorder Severe | Kidney Diseases Progressive | Liver diseases Progressive | Hematological Disease Progressive | Gastrointestinal Diseases Progressive | Endocrine System Diseases Progressive | Lung diseases Progressive | Heart Diseases Progressive | Nervous system disorder Progressive | Cerebral disorder Progressive | Kidney Diseases Uncontrolled | Liver diseases Uncontrolled | Hematological Disease Uncontrolled | Gastrointestinal Diseases Uncontrolled | Endocrine System Diseases Uncontrolled | Lung diseases Uncontrolled | Heart Diseases Uncontrolled | Nervous system disorder Uncontrolled | Cerebral disorder Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0041296
UMLS CUI [4,1]
C0332167
UMLS CUI [4,2]
C0009450
UMLS CUI [5]
C0024314
UMLS CUI [6]
C0019163
UMLS CUI [7]
C0019196
UMLS CUI [8]
C0524909
UMLS CUI [9]
C0524910
UMLS CUI [10]
C0019693
UMLS CUI [11]
C0006826
UMLS CUI [12,1]
C0022658
UMLS CUI [12,2]
C0205082
UMLS CUI [13,1]
C0023895
UMLS CUI [13,2]
C0205082
UMLS CUI [14,1]
C0018939
UMLS CUI [14,2]
C0205082
UMLS CUI [15,1]
C0017178
UMLS CUI [15,2]
C0205082
UMLS CUI [16,1]
C0014130
UMLS CUI [16,2]
C0205082
UMLS CUI [17,1]
C0024115
UMLS CUI [17,2]
C0205082
UMLS CUI [18,1]
C0018799
UMLS CUI [18,2]
C0205082
UMLS CUI [19,1]
C0027765
UMLS CUI [19,2]
C0205082
UMLS CUI [20,1]
C0234387
UMLS CUI [20,2]
C0205082
UMLS CUI [21,1]
C0022658
UMLS CUI [21,2]
C0205329
UMLS CUI [22,1]
C0023895
UMLS CUI [22,2]
C0205329
UMLS CUI [23,1]
C0018939
UMLS CUI [23,2]
C0205329
UMLS CUI [24,1]
C0017178
UMLS CUI [24,2]
C0205329
UMLS CUI [25,1]
C0014130
UMLS CUI [25,2]
C0205329
UMLS CUI [26,1]
C0024115
UMLS CUI [26,2]
C0205329
UMLS CUI [27,1]
C0018799
UMLS CUI [27,2]
C0205329
UMLS CUI [28,1]
C0027765
UMLS CUI [28,2]
C0205329
UMLS CUI [29,1]
C0234387
UMLS CUI [29,2]
C0205329
UMLS CUI [30,1]
C0022658
UMLS CUI [30,2]
C0205318
UMLS CUI [31,1]
C0023895
UMLS CUI [31,2]
C0205318
UMLS CUI [32,1]
C0018939
UMLS CUI [32,2]
C0205318
UMLS CUI [33,1]
C0017178
UMLS CUI [33,2]
C0205318
UMLS CUI [34,1]
C0014130
UMLS CUI [34,2]
C0205318
UMLS CUI [35,1]
C0024115
UMLS CUI [35,2]
C0205318
UMLS CUI [36,1]
C0018799
UMLS CUI [36,2]
C0205318
UMLS CUI [37,1]
C0027765
UMLS CUI [37,2]
C0205318
UMLS CUI [38,1]
C0234387
UMLS CUI [38,2]
C0205318
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00753454

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Comprehension Informed Consent
Item
patients must be able to understand the written informed consent form (icf)
boolean
C0162340 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Therapy responder Improvement Percentage | Clinical Trial Rheumatoid Arthritis Completed | Subject is Randomized | Criteria Fulfill Flare
Item
patients must have achieved an acr20 (american college of rheumatology) response at week 16 and completed the entire c87077 (nct00580840) study or patients having been randomized at week 18 and having met the pre-defined criteria for flare
boolean
C0919876 (UMLS CUI [1,1])
C2986411 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C3815594 (UMLS CUI [3])
C0243161 (UMLS CUI [4,1])
C1550543 (UMLS CUI [4,2])
C1517205 (UMLS CUI [4,3])
Protocol Compliance Clinical Trial Specified
Item
patients must have complied with the protocol requirements during their participation in c87077 (nct00580840)
boolean
C0525058 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Childbearing Potential Urine pregnancy test negative
Item
female patients of childbearing potential must have a negative urine pregnancy test at entry and must continue to have negative urine pregnancy tests throughout their study participation
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Protocol Compliance
Item
patients must be willing to comply with protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Arthritis Other
Item
patients must not have a diagnosis of any other inflammatory arthritis
boolean
C0003864 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Arthritis Secondary Symptomatic Noninflammatory | Interference Evaluation Investigational New Drugs
Item
patients must not have a secondary, non-inflammatory type of arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of rheumatoid arthritis (ra)
boolean
C0003864 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0442743 (UMLS CUI [1,4])
C0521102 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Prosthetic joint infection
Item
patients must not have a history of an infected joint prosthesis with that prosthesis still in situ
boolean
C0410808 (UMLS CUI [1])
Pregnancy | Chronic infectious disease | Tuberculosis | High risk of Communicable Diseases | Lymphoproliferative Disorders | Hepatitis B | Hepatitis C | Hepatitis B, Chronic | Hepatitis C, Chronic | HIV Infections | Malignant Neoplasms | Kidney Diseases Severe | Liver diseases Severe | Hematological Disease Severe | Gastrointestinal Diseases Severe | Endocrine System Diseases Severe | Lung diseases Severe | Heart Diseases Severe | Nervous system disorder Severe | Cerebral disorder Severe | Kidney Diseases Progressive | Liver diseases Progressive | Hematological Disease Progressive | Gastrointestinal Diseases Progressive | Endocrine System Diseases Progressive | Lung diseases Progressive | Heart Diseases Progressive | Nervous system disorder Progressive | Cerebral disorder Progressive | Kidney Diseases Uncontrolled | Liver diseases Uncontrolled | Hematological Disease Uncontrolled | Gastrointestinal Diseases Uncontrolled | Endocrine System Diseases Uncontrolled | Lung diseases Uncontrolled | Heart Diseases Uncontrolled | Nervous system disorder Uncontrolled | Cerebral disorder Uncontrolled
Item
patients who do not meet the medical history exclusion criteria, as defined per protocol. examples of exclusionary criteria (not all-inclusive): pregnancy, chronic infection, active tuberculosis (tb), high risk of infection, lymphproliferative disorder, acute or chronic viral hepatitis b or c, known human immunodeficiency virus (hiv), malignancy or history of malignancy, history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
boolean
C0032961 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
C0332167 (UMLS CUI [4,1])
C0009450 (UMLS CUI [4,2])
C0024314 (UMLS CUI [5])
C0019163 (UMLS CUI [6])
C0019196 (UMLS CUI [7])
C0524909 (UMLS CUI [8])
C0524910 (UMLS CUI [9])
C0019693 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
C0022658 (UMLS CUI [12,1])
C0205082 (UMLS CUI [12,2])
C0023895 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0018939 (UMLS CUI [14,1])
C0205082 (UMLS CUI [14,2])
C0017178 (UMLS CUI [15,1])
C0205082 (UMLS CUI [15,2])
C0014130 (UMLS CUI [16,1])
C0205082 (UMLS CUI [16,2])
C0024115 (UMLS CUI [17,1])
C0205082 (UMLS CUI [17,2])
C0018799 (UMLS CUI [18,1])
C0205082 (UMLS CUI [18,2])
C0027765 (UMLS CUI [19,1])
C0205082 (UMLS CUI [19,2])
C0234387 (UMLS CUI [20,1])
C0205082 (UMLS CUI [20,2])
C0022658 (UMLS CUI [21,1])
C0205329 (UMLS CUI [21,2])
C0023895 (UMLS CUI [22,1])
C0205329 (UMLS CUI [22,2])
C0018939 (UMLS CUI [23,1])
C0205329 (UMLS CUI [23,2])
C0017178 (UMLS CUI [24,1])
C0205329 (UMLS CUI [24,2])
C0014130 (UMLS CUI [25,1])
C0205329 (UMLS CUI [25,2])
C0024115 (UMLS CUI [26,1])
C0205329 (UMLS CUI [26,2])
C0018799 (UMLS CUI [27,1])
C0205329 (UMLS CUI [27,2])
C0027765 (UMLS CUI [28,1])
C0205329 (UMLS CUI [28,2])
C0234387 (UMLS CUI [29,1])
C0205329 (UMLS CUI [29,2])
C0022658 (UMLS CUI [30,1])
C0205318 (UMLS CUI [30,2])
C0023895 (UMLS CUI [31,1])
C0205318 (UMLS CUI [31,2])
C0018939 (UMLS CUI [32,1])
C0205318 (UMLS CUI [32,2])
C0017178 (UMLS CUI [33,1])
C0205318 (UMLS CUI [33,2])
C0014130 (UMLS CUI [34,1])
C0205318 (UMLS CUI [34,2])
C0024115 (UMLS CUI [35,1])
C0205318 (UMLS CUI [35,2])
C0018799 (UMLS CUI [36,1])
C0205318 (UMLS CUI [36,2])
C0027765 (UMLS CUI [37,1])
C0205318 (UMLS CUI [37,2])
C0234387 (UMLS CUI [38,1])
C0205318 (UMLS CUI [38,2])
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