ID

31872

Beschrijving

Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies; ODM derived from: https://clinicaltrials.gov/show/NCT00805467

Link

https://clinicaltrials.gov/show/NCT00805467

Trefwoorden

Versies (1)
  1. 05-10-18 05-10-18 -
Houder van rechten

See clinicaltrials.gov

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5 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00805467

Engels

Eligibility Rheumatoid Arthritis NCT00805467

1 Formulieren  
Inclusion Criteria
Beschrijving

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
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients who are being treated in study c-788-006x
Beschrijving

Patients Treated Clinical Trial Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205369
patients who completed studies c-788-010 or c-788-011 and did not withdraw due to adverse events
Beschrijving

Patients Clinical Trial Specified Completion | Absence Patient withdrawn from trial Due to Adverse event

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [1,4]
C0205197
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0422727
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0877248
patients who withdrew from study c-788-010 at month 4 or month 5 because of a pre-defined lack of efficacy
Beschrijving

Patient withdrawn from trial specified | Etiology Lack of Efficacy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0235828
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 pregnancy test at the time of entry and at each laboratory determination.
Beschrijving

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

Datatype

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]
C0009907
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]
C0427780
Exclusion Criteria
Beschrijving

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:
Beschrijving

Comorbidity Affecting Completion of clinical trial | Medical condition Affecting Completion of clinical trial | Exception Arthritis | Laboratory test result abnormal Affecting Completion of clinical trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
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]
C1705847
UMLS CUI [3,2]
C0003864
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C2732579
1. unresolved grade 2 or greater toxicity in a ra protocol studying r788
Beschrijving

Toxicity CTCAE Grades | Resolution Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C0332268
2. uncontrolled or poorly controlled hypertension;
Beschrijving

Uncontrolled hypertension | Poor hypertension control

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0421190
3. recent (within past 2 months) serious surgery or infectious disease;
Beschrijving

Operative Surgical Procedures Serious | Communicable Disease Serious

Datatype

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 (since enrollment in prior r788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma;
Beschrijving

Malignant Neoplasms | Cancer treatment | Exception Skin carcinoma | Lymphoma

Datatype

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. known to be positive for hepatitis b, hepatitis c, hiv or tuberculosis;
Beschrijving

Hepatitis B positive | Hepatitis C positive | HIV Seropositivity | Tuberculosis test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0019699
UMLS CUI [4]
C1739367
6. interstitial pneumonitis or active pulmonary infection;
Beschrijving

Pneumonia, Interstitial | Infectious disease of lung

Datatype

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2]
C0876973
7. known laboratory abnormalities: alt > 1.2 x uln, creatinine >1.5x uln, an anc <2,500/mm3 or 2.5 x 109/l, lymphocyte count < 600/mm3 or 0.6 x 109l, hgb < 9 g/dl or 5 mmol/l, platelet count <125,000/mm3 or 125 x 109/l are excluded.
Beschrijving

Laboratory test result abnormal | Alanine aminotransferase increased | Serum creatinine raised | Absolute neutrophil count | Lymphocyte Count measurement | Hemoglobin measurement | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0700225
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0200635
UMLS CUI [6]
C0518015
UMLS CUI [7]
C0032181
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.
Beschrijving

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

Datatype

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 is unable to report for clinical and laboratory monitoring as per protocol.
Beschrijving

Report Monitoring Clinical Unable | Report Laboratory Monitoring Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700287
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0205210
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0700287
UMLS CUI [2,2]
C0022877
UMLS CUI [2,3]
C1283169
UMLS CUI [2,4]
C1299582
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Similar models

Eligibility Rheumatoid Arthritis NCT00805467

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Patients Treated Clinical Trial Specified
Item
patients who are being treated in study c-788-006x
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Patients Clinical Trial Specified Completion | Absence Patient withdrawn from trial Due to Adverse event
Item
patients who completed studies c-788-010 or c-788-011 and did not withdraw due to adverse events
boolean
C0030705 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0877248 (UMLS CUI [2,4])
Patient withdrawn from trial specified | Etiology Lack of Efficacy
Item
patients who withdrew from study c-788-010 at month 4 or month 5 because of a pre-defined lack of efficacy
boolean
C0422727 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0235828 (UMLS CUI [2,2])
Childbearing Potential Informed R788 compound | Childbearing Potential Sexually active Contraceptive methods | Contraceptives, Oral | Contraception, Barrier | Oral Hormonal Contraceptives Active Long-term | Childbearing Potential Breast Feeding Absent | Childbearing Potential 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 pregnancy test at the time of entry 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])
C0009907 (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])
C0427780 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
Comorbidity Affecting Completion of clinical trial | Medical condition Affecting Completion of clinical trial | Exception Arthritis | 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
C0009488 (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])
C1705847 (UMLS CUI [3,1])
C0003864 (UMLS CUI [3,2])
C0438215 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
Toxicity CTCAE Grades | Resolution Lacking
Item
1. unresolved grade 2 or greater toxicity in a ra protocol studying r788
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1514893 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Uncontrolled hypertension | Poor hypertension control
Item
2. uncontrolled or poorly controlled hypertension;
boolean
C1868885 (UMLS CUI [1])
C0421190 (UMLS CUI [2])
Operative Surgical Procedures Serious | Communicable Disease Serious
Item
3. recent (within past 2 months) 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 (since enrollment in prior r788 study) of, or treatment for, a malignancy other than non-melanomatous 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 positive | Hepatitis C positive | HIV Seropositivity | Tuberculosis test positive
Item
5. known to be positive for hepatitis b, hepatitis c, hiv or tuberculosis;
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
C1739367 (UMLS CUI [4])
Pneumonia, Interstitial | Infectious disease of lung
Item
6. interstitial pneumonitis or active pulmonary infection;
boolean
C0206061 (UMLS CUI [1])
C0876973 (UMLS CUI [2])
Laboratory test result abnormal | Alanine aminotransferase increased | Serum creatinine raised | Absolute neutrophil count | Lymphocyte Count measurement | Hemoglobin measurement | Platelet Count measurement
Item
7. known laboratory abnormalities: alt > 1.2 x uln, creatinine >1.5x uln, an anc <2,500/mm3 or 2.5 x 109/l, lymphocyte count < 600/mm3 or 0.6 x 109l, hgb < 9 g/dl or 5 mmol/l, platelet count <125,000/mm3 or 125 x 109/l are excluded.
boolean
C0438215 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0200635 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
C0032181 (UMLS CUI [7])
Substance Use Disorders | Drug Dependence | Alcoholic Intoxication, Chronic | Alcohol consumption U/week | Beer Alcohol unit | Wine Alcohol unit | Dessert wine Alcohol unit | Distilled spirits Alcohol unit
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])
Report Monitoring Clinical Unable | Report Laboratory Monitoring Unable
Item
the patient is unable to report for clinical and laboratory monitoring as per protocol.
boolean
C0700287 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0700287 (UMLS CUI [2,1])
C0022877 (UMLS CUI [2,2])
C1283169 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
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