ID

31891

Beschreibung

Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy; ODM derived from: https://clinicaltrials.gov/show/NCT00948610

Link

https://clinicaltrials.gov/show/NCT00948610

Stichworte

Versionen (1)
  1. 07.10.18 07.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00948610

Englisch

Eligibility Rheumatoid Arthritis NCT00948610

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. rheumatoid arthritis patients will meet american college of rheumatology revised criteria (arnett, edworthy et al. 1988). this requires at least four of the following seven criteria: 1) morning joint stiffness; 2) arthritis in 3 or more joint areas; 3) arthritis of hand joints; 4) symmetric arthritis; 5) rheumatoid nodules; 6) presence of serum rheumatoid factor and 7) changes on posteroanterior hand and wrist radiographs. in addition, criteria 1-4 must be present for at least four weeks. subjects must be between 18 and 85 years of age.
Beschreibung

Rheumatoid Arthritis | Morning stiffness joint Duration | Arthritis Joints Quantity Duration | Arthritis Hand joint Duration | Arthritis Symmetric Duration | Rheumatoid Nodules | Rheumatoid factor presence in serum | Change Posteroanterior radiography Hand | Change Posteroanterior radiography Wrist | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2,1]
C0457086
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0003864
UMLS CUI [3,2]
C0022417
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0449238
UMLS CUI [4,1]
C0003864
UMLS CUI [4,2]
C0459470
UMLS CUI [4,3]
C0449238
UMLS CUI [5,1]
C0003864
UMLS CUI [5,2]
C0332516
UMLS CUI [5,3]
C0449238
UMLS CUI [6]
C0035450
UMLS CUI [7]
C4481755
UMLS CUI [8,1]
C0392747
UMLS CUI [8,2]
C0202573
UMLS CUI [8,3]
C0018563
UMLS CUI [9,1]
C0392747
UMLS CUI [9,2]
C0202573
UMLS CUI [9,3]
C0043262
UMLS CUI [10]
C0001779
2. if rheumatoid arthritis patients are receiving treatment with traditional disease modifying antirheumatic drugs (dmard), such as methotrexate, sulfasalazine or hydroxychloroquine, they must be on a stable regime for one month before study and stable throughout study.
Beschreibung

Rheumatoid Arthritis | DMARDs Dose Stable | Methotrexate | Sulfasalazine | Hydroxychloroquine

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2,1]
C0242708
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0025677
UMLS CUI [4]
C0036078
UMLS CUI [5]
C0020336
3. if rheumatoid arthritis patients have received treatment with a tnf antagonist or other biologic medication, they must be drug free for greater than 3 months.
Beschreibung

Rheumatoid Arthritis | Anti-TNF drug | Anti-TNF drug Free Duration | Biological agent | Biological agent Free Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C1562242
UMLS CUI [3,1]
C1562242
UMLS CUI [3,2]
C0332296
UMLS CUI [3,3]
C0449238
UMLS CUI [4]
C0005515
UMLS CUI [5,1]
C0005515
UMLS CUI [5,2]
C0332296
UMLS CUI [5,3]
C0449238
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. steroids - individuals currently taking greater than an equivalent of 10 mg of prednisone will be excluded given the potent anti-inflammatory effects of such medications.
Beschreibung

Steroids | Prednisone Dosage Equivalent

Datentyp

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205163
2. opioids - individuals using multiple daily dosage schedule of opioid agents such as oxycodone (percocet), hydrocodone (vicodin), morphine, dilaudid will be excluded.
Beschreibung

Opioids Daily Dose Multiple | Oxycodone | Percocet | Hydrocodone | Vicodin | Morphine | Dilaudid

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242402
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439064
UMLS CUI [2]
C0030049
UMLS CUI [3]
C0086787
UMLS CUI [4]
C0020264
UMLS CUI [5]
C0483514
UMLS CUI [6]
C0026549
UMLS CUI [7]
C0728755
3. co-morbid medical disorders - the presence of active unstable and uncontrolled co-morbid medical conditions such as diabetes, cardiovascular diseases, and cancer will be exclusionary criteria. in particular, individuals with co-morbid inflammatory disorders such as crohn's disease and ulcerative colitis and other autoimmune disorders will be excluded. any uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or put the study participant at undue risk will also be considered exclusionary criteria.
Beschreibung

Comorbidity Unstable Uncontrolled | Diabetes Mellitus | Cardiovascular Diseases | Malignant Neoplasms | Inflammatory disorder | Crohn Disease | Ulcerative Colitis | Autoimmune Diseases | Medical condition Uncontrolled Interferes with Interventional procedure | Medical condition Uncontrolled Study Subject Participation Status At risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0006826
UMLS CUI [5]
C1290884
UMLS CUI [6]
C0010346
UMLS CUI [7]
C0009324
UMLS CUI [8]
C0004364
UMLS CUI [9,1]
C3843040
UMLS CUI [9,2]
C0205318
UMLS CUI [9,3]
C0521102
UMLS CUI [9,4]
C0184661
UMLS CUI [10,1]
C3843040
UMLS CUI [10,2]
C0205318
UMLS CUI [10,3]
C2348568
UMLS CUI [10,4]
C1444641
4. chronic infections - individuals with chronic infections will also be excluded because of effects on immune markers measured in study.
Beschreibung

Chronic infectious disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0151317
5. co-morbid pain disorders - individuals with co-morbid pain disorders such as fibromyalgia will also be excluded. individuals with fibromyalgia have been found to have sleep abnormalities as well as daytime fatigue and pain (drewes 1999) and thus could confound findings.
Beschreibung

Pain Disorder | Fibromyalgia Interferes with Findings | Sleep abnormalities | Fatigue Daytime | Pain Daytime

Datentyp

boolean

Alias
UMLS CUI [1]
C0391976
UMLS CUI [2,1]
C0016053
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2607943
UMLS CUI [3]
C3277092
UMLS CUI [4,1]
C0015672
UMLS CUI [4,2]
C0332169
UMLS CUI [5,1]
C0030193
UMLS CUI [5,2]
C0332169
6. psychiatric disorders - current conditions such as major depressive disorder, bipolar disorder and risk for suicide will also be considered exclusionary criteria.
Beschreibung

Major Depressive Disorder | Bipolar Disorder | At risk for suicide

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0563664
7. gender-based criteria - pregnant or breast-feeding women will also be excluded because of their effects on neuroendocrine systems and sleep
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00948610

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis | Morning stiffness joint Duration | Arthritis Joints Quantity Duration | Arthritis Hand joint Duration | Arthritis Symmetric Duration | Rheumatoid Nodules | Rheumatoid factor presence in serum | Change Posteroanterior radiography Hand | Change Posteroanterior radiography Wrist | Age
Item
1. rheumatoid arthritis patients will meet american college of rheumatology revised criteria (arnett, edworthy et al. 1988). this requires at least four of the following seven criteria: 1) morning joint stiffness; 2) arthritis in 3 or more joint areas; 3) arthritis of hand joints; 4) symmetric arthritis; 5) rheumatoid nodules; 6) presence of serum rheumatoid factor and 7) changes on posteroanterior hand and wrist radiographs. in addition, criteria 1-4 must be present for at least four weeks. subjects must be between 18 and 85 years of age.
boolean
C0003873 (UMLS CUI [1])
C0457086 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0003864 (UMLS CUI [3,1])
C0022417 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C0003864 (UMLS CUI [4,1])
C0459470 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
C0003864 (UMLS CUI [5,1])
C0332516 (UMLS CUI [5,2])
C0449238 (UMLS CUI [5,3])
C0035450 (UMLS CUI [6])
C4481755 (UMLS CUI [7])
C0392747 (UMLS CUI [8,1])
C0202573 (UMLS CUI [8,2])
C0018563 (UMLS CUI [8,3])
C0392747 (UMLS CUI [9,1])
C0202573 (UMLS CUI [9,2])
C0043262 (UMLS CUI [9,3])
C0001779 (UMLS CUI [10])
Rheumatoid Arthritis | DMARDs Dose Stable | Methotrexate | Sulfasalazine | Hydroxychloroquine
Item
2. if rheumatoid arthritis patients are receiving treatment with traditional disease modifying antirheumatic drugs (dmard), such as methotrexate, sulfasalazine or hydroxychloroquine, they must be on a stable regime for one month before study and stable throughout study.
boolean
C0003873 (UMLS CUI [1])
C0242708 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0025677 (UMLS CUI [3])
C0036078 (UMLS CUI [4])
C0020336 (UMLS CUI [5])
Rheumatoid Arthritis | Anti-TNF drug | Anti-TNF drug Free Duration | Biological agent | Biological agent Free Duration
Item
3. if rheumatoid arthritis patients have received treatment with a tnf antagonist or other biologic medication, they must be drug free for greater than 3 months.
boolean
C0003873 (UMLS CUI [1])
C1562242 (UMLS CUI [2])
C1562242 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C0005515 (UMLS CUI [4])
C0005515 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
C0449238 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Steroids | Prednisone Dosage Equivalent
Item
1. steroids - individuals currently taking greater than an equivalent of 10 mg of prednisone will be excluded given the potent anti-inflammatory effects of such medications.
boolean
C0038317 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
Opioids Daily Dose Multiple | Oxycodone | Percocet | Hydrocodone | Vicodin | Morphine | Dilaudid
Item
2. opioids - individuals using multiple daily dosage schedule of opioid agents such as oxycodone (percocet), hydrocodone (vicodin), morphine, dilaudid will be excluded.
boolean
C0242402 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0030049 (UMLS CUI [2])
C0086787 (UMLS CUI [3])
C0020264 (UMLS CUI [4])
C0483514 (UMLS CUI [5])
C0026549 (UMLS CUI [6])
C0728755 (UMLS CUI [7])
Comorbidity Unstable Uncontrolled | Diabetes Mellitus | Cardiovascular Diseases | Malignant Neoplasms | Inflammatory disorder | Crohn Disease | Ulcerative Colitis | Autoimmune Diseases | Medical condition Uncontrolled Interferes with Interventional procedure | Medical condition Uncontrolled Study Subject Participation Status At risk
Item
3. co-morbid medical disorders - the presence of active unstable and uncontrolled co-morbid medical conditions such as diabetes, cardiovascular diseases, and cancer will be exclusionary criteria. in particular, individuals with co-morbid inflammatory disorders such as crohn's disease and ulcerative colitis and other autoimmune disorders will be excluded. any uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or put the study participant at undue risk will also be considered exclusionary criteria.
boolean
C0009488 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C1290884 (UMLS CUI [5])
C0010346 (UMLS CUI [6])
C0009324 (UMLS CUI [7])
C0004364 (UMLS CUI [8])
C3843040 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C0184661 (UMLS CUI [9,4])
C3843040 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
C2348568 (UMLS CUI [10,3])
C1444641 (UMLS CUI [10,4])
Chronic infectious disease
Item
4. chronic infections - individuals with chronic infections will also be excluded because of effects on immune markers measured in study.
boolean
C0151317 (UMLS CUI [1])
Pain Disorder | Fibromyalgia Interferes with Findings | Sleep abnormalities | Fatigue Daytime | Pain Daytime
Item
5. co-morbid pain disorders - individuals with co-morbid pain disorders such as fibromyalgia will also be excluded. individuals with fibromyalgia have been found to have sleep abnormalities as well as daytime fatigue and pain (drewes 1999) and thus could confound findings.
boolean
C0391976 (UMLS CUI [1])
C0016053 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2607943 (UMLS CUI [2,3])
C3277092 (UMLS CUI [3])
C0015672 (UMLS CUI [4,1])
C0332169 (UMLS CUI [4,2])
C0030193 (UMLS CUI [5,1])
C0332169 (UMLS CUI [5,2])
Major Depressive Disorder | Bipolar Disorder | At risk for suicide
Item
6. psychiatric disorders - current conditions such as major depressive disorder, bipolar disorder and risk for suicide will also be considered exclusionary criteria.
boolean
C1269683 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0563664 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
7. gender-based criteria - pregnant or breast-feeding women will also be excluded because of their effects on neuroendocrine systems and sleep
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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