ID

31845

Beskrivning

Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00665925

Länk

https://clinicaltrials.gov/show/NCT00665925

Nyckelord

Versioner (1)
  1. 2018-10-02 2018-10-02 -
Rättsinnehavare

See clinicaltrials.gov

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2 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00665925

Engelsk

Eligibility Rheumatoid Arthritis NCT00665925

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must give written informed consent by signing an irb/ec-approved informed consent form (icf) prior to admission to this study.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
males and females, 18 years of age or older, with active ra for at least 6 months prior to day 1 dosing.
Beskrivning

Age | Rheumatoid Arthritis Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0449238
patients must have been receiving weekly methotrexate doses (7.5-25 mg/week) for a minimum of 3 months prior to day 1 dosing and must be receiving a stable mtx dose, with no change in route, for the previous 6 weeks prior to day 1 dosing.
Beskrivning

Methotrexate Dose Stable U/week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
`patients must be receiving a folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to day 1 dosing.
Beskrivning

Folic acid supplementation Dose Stable | Folinic acid Supplementation Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0556110
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0023413
UMLS CUI [2,2]
C0242297
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
females of childbearing potential must be fully informed of the potential for r788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). these patients must not be lactating and must have a negative urine pregnancy test at the time of randomization and at each laboratory determination.
Beskrivning

Childbearing Potential Informed R788 compound | Childbearing Potential Sexually active Contraceptive methods | Contraceptives, Oral | Contraception, Barrier | Hormonal contraception Active Long-term | Childbearing Potential Breast Feeding Absent | Childbearing Potential Urine pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C1522154
UMLS CUI [1,3]
C2002836
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [3]
C0009905
UMLS CUI [4]
C0004764
UMLS CUI [5,1]
C2985296
UMLS CUI [5,2]
C0205177
UMLS CUI [5,3]
C0443252
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0006147
UMLS CUI [6,3]
C0332197
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0430057
the patient must otherwise be in good health as determined by the investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period. see exclusion criteria for specific exclusions.
Beskrivning

General health good Medical History | General health good Physical Examination | General health good Laboratory test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1277245
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C1277245
UMLS CUI [3,2]
C0022885
in the investigator's opinion, the patient has the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the investigator and to participate in, and to comply with, the requirements of the entire protocol.
Beskrivning

Comprehension Study Protocol | Able to communicate Research Personnel | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C2364293
UMLS CUI [2,2]
C0035173
UMLS CUI [3]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study. specifically, excluded are patients with the following:
Beskrivning

Illness Affecting Completion of clinical trial | Medical condition Affecting Completion of clinical trial | Laboratory test result abnormal Affecting Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0438215
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C2732579
1. uncontrolled or poorly controlled hypertension;
Beskrivning

Uncontrolled hypertension | Poor hypertension control

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0421190
2. other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, lyme disease, reiter's syndrome);
Beskrivning

Autoimmune Disease | Arthritis, Psoriatic | Lupus Erythematosus | Mixed Connective Tissue Disease | Arthritis Syndrome | Gout | Lyme Disease | Reiter Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0003872
UMLS CUI [3]
C0409974
UMLS CUI [4]
C0026272
UMLS CUI [5,1]
C0003864
UMLS CUI [5,2]
C0039082
UMLS CUI [6]
C0018099
UMLS CUI [7]
C0024198
UMLS CUI [8]
C0035012
3. recent (within past 2 months prior to day 1 dosing) serious surgery or infectious disease;
Beskrivning

Operative Surgical Procedures Serious | Communicable Disease Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
4. recent history (past 5 years prior to day 1 dosing) of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;
Beskrivning

Malignant Neoplasms | Cancer treatment | Exception Skin carcinoma | Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4]
C0024299
5. hepatitis b ;
Beskrivning

Hepatitis B

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
6. hepatitis c ;
Beskrivning

Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019196
7. interstitial pneumonitis or active pulmonary infection on chest x-ray;
Beskrivning

Interstitial Pneumonia Chest X-ray | Infectious disease of lung Chest X-ray

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0206061
UMLS CUI [1,2]
C0039985
UMLS CUI [2,1]
C0876973
UMLS CUI [2,2]
C0039985
8. tuberculosis (tb): the tb skin test should be negative.
Beskrivning

Tuberculosis | Tuberculosis Skin Test Negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2,1]
C3282342
UMLS CUI [2,2]
C1513916
9. known laboratory abnormalities.
Beskrivning

Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
the patient has a history of substance abuse, drug addiction or alcoholism. patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. patients who cannot reliably comply with this should be excluded. a unit of alcohol is defined as the following: beer=12 oz or 355 ml; wine = 5 oz or 148 ml; sweet dessert wine=3 oz or 89 ml; 80 proof distilled spirits= 1.5 oz or 44 ml.
Beskrivning

Substance Use Disorders | Drug Dependence | Alcoholic Intoxication, Chronic | Alcohol consumption U/week | Beer Alcohol units | Wine Alcohol units | Dessert wine Alcohol units | Distilled spirits Alcohol units

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C1510472
UMLS CUI [3]
C0001973
UMLS CUI [4,1]
C0001948
UMLS CUI [4,2]
C0560588
UMLS CUI [5,1]
C0004922
UMLS CUI [5,2]
C0556604
UMLS CUI [6,1]
C0043188
UMLS CUI [6,2]
C0556604
UMLS CUI [7,1]
C0454276
UMLS CUI [7,2]
C0556604
UMLS CUI [8,1]
C0301611
UMLS CUI [8,2]
C0556604
the patient has been treated previously treated with r788 under a different protocol.
Beskrivning

Study Subject Participation Status | R788 compound

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2002836
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Similar models

Eligibility Rheumatoid Arthritis NCT00665925

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients must give written informed consent by signing an irb/ec-approved informed consent form (icf) prior to admission to this study.
boolean
C0021430 (UMLS CUI [1])
Age | Rheumatoid Arthritis Duration
Item
males and females, 18 years of age or older, with active ra for at least 6 months prior to day 1 dosing.
boolean
C0001779 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Methotrexate Dose Stable U/week
Item
patients must have been receiving weekly methotrexate doses (7.5-25 mg/week) for a minimum of 3 months prior to day 1 dosing and must be receiving a stable mtx dose, with no change in route, for the previous 6 weeks prior to day 1 dosing.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Folic acid supplementation Dose Stable | Folinic acid Supplementation Dose Stable
Item
`patients must be receiving a folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to day 1 dosing.
boolean
C0556110 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0023413 (UMLS CUI [2,1])
C0242297 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Childbearing Potential Informed R788 compound | Childbearing Potential Sexually active Contraceptive methods | Contraceptives, Oral | Contraception, Barrier | Hormonal contraception Active Long-term | Childbearing Potential Breast Feeding Absent | Childbearing Potential Urine pregnancy test negative
Item
females of childbearing potential must be fully informed of the potential for r788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). these patients must not be lactating and must have a negative urine pregnancy test at the time of randomization and at each laboratory determination.
boolean
C3831118 (UMLS CUI [1,1])
C1522154 (UMLS CUI [1,2])
C2002836 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0009905 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C2985296 (UMLS CUI [5,1])
C0205177 (UMLS CUI [5,2])
C0443252 (UMLS CUI [5,3])
C3831118 (UMLS CUI [6,1])
C0006147 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])
General health good Medical History | General health good Physical Examination | General health good Laboratory test
Item
the patient must otherwise be in good health as determined by the investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period. see exclusion criteria for specific exclusions.
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1277245 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
Comprehension Study Protocol | Able to communicate Research Personnel | Protocol Compliance
Item
in the investigator's opinion, the patient has the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the investigator and to participate in, and to comply with, the requirements of the entire protocol.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2364293 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Illness Affecting Completion of clinical trial | Medical condition Affecting Completion of clinical trial | Laboratory test result abnormal Affecting Completion of clinical trial
Item
the patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study. specifically, excluded are patients with the following:
boolean
C0221423 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0438215 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
Uncontrolled hypertension | Poor hypertension control
Item
1. uncontrolled or poorly controlled hypertension;
boolean
C1868885 (UMLS CUI [1])
C0421190 (UMLS CUI [2])
Autoimmune Disease | Arthritis, Psoriatic | Lupus Erythematosus | Mixed Connective Tissue Disease | Arthritis Syndrome | Gout | Lyme Disease | Reiter Syndrome
Item
2. other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, lyme disease, reiter's syndrome);
boolean
C0004364 (UMLS CUI [1])
C0003872 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C0026272 (UMLS CUI [4])
C0003864 (UMLS CUI [5,1])
C0039082 (UMLS CUI [5,2])
C0018099 (UMLS CUI [6])
C0024198 (UMLS CUI [7])
C0035012 (UMLS CUI [8])
Operative Surgical Procedures Serious | Communicable Disease Serious
Item
3. recent (within past 2 months prior to day 1 dosing) serious surgery or infectious disease;
boolean
C0543467 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Malignant Neoplasms | Cancer treatment | Exception Skin carcinoma | Lymphoma
Item
4. recent history (past 5 years prior to day 1 dosing) of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C0024299 (UMLS CUI [4])
Hepatitis B
Item
5. hepatitis b ;
boolean
C0019163 (UMLS CUI [1])
Hepatitis C
Item
6. hepatitis c ;
boolean
C0019196 (UMLS CUI [1])
Interstitial Pneumonia Chest X-ray | Infectious disease of lung Chest X-ray
Item
7. interstitial pneumonitis or active pulmonary infection on chest x-ray;
boolean
C0206061 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0876973 (UMLS CUI [2,1])
C0039985 (UMLS CUI [2,2])
Tuberculosis | Tuberculosis Skin Test Negative
Item
8. tuberculosis (tb): the tb skin test should be negative.
boolean
C0041296 (UMLS CUI [1])
C3282342 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Laboratory test result abnormal
Item
9. known laboratory abnormalities.
boolean
C0438215 (UMLS CUI [1])
Substance Use Disorders | Drug Dependence | Alcoholic Intoxication, Chronic | Alcohol consumption U/week | Beer Alcohol units | Wine Alcohol units | Dessert wine Alcohol units | Distilled spirits Alcohol units
Item
the patient has a history of substance abuse, drug addiction or alcoholism. patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. patients who cannot reliably comply with this should be excluded. a unit of alcohol is defined as the following: beer=12 oz or 355 ml; wine = 5 oz or 148 ml; sweet dessert wine=3 oz or 89 ml; 80 proof distilled spirits= 1.5 oz or 44 ml.
boolean
C0038586 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0001973 (UMLS CUI [3])
C0001948 (UMLS CUI [4,1])
C0560588 (UMLS CUI [4,2])
C0004922 (UMLS CUI [5,1])
C0556604 (UMLS CUI [5,2])
C0043188 (UMLS CUI [6,1])
C0556604 (UMLS CUI [6,2])
C0454276 (UMLS CUI [7,1])
C0556604 (UMLS CUI [7,2])
C0301611 (UMLS CUI [8,1])
C0556604 (UMLS CUI [8,2])
Study Subject Participation Status | R788 compound
Item
the patient has been treated previously treated with r788 under a different protocol.
boolean
C2348568 (UMLS CUI [1])
C2002836 (UMLS CUI [2])
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