ID

37104

Description

A Study of Subjects With Rheumatoid Arthritis Who Are in Clinical Remission to Investigate Patient and Disease Characteristics That Could Help Identify Which Subjects Could Reduce Their Adalimumab Dose Without Flaring; ODM derived from: https://clinicaltrials.gov/show/NCT02198651

Link

https://clinicaltrials.gov/show/NCT02198651

Keywords

Versions (1)
  1. 7/3/19 7/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02198651

English

Eligibility Rheumatoid Arthritis NCT02198651

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject has a diagnosis of rheumatoid arthritis (ra) as defined by the 1987 revised american college of rheumatology (acr) classification criteria and/or the acr
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
/european league against rheumatism (eular) 2010 classification criteria (any duration since diagnosis).
Description

Classification Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0008902
UMLS CUI [1,2]
C0243161
2. subject must meet the following criteria:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
must be treated with adalimumab 40 mg sc eow for at least 12 months prior to screening visit
Description

Adalimumab Subcutaneous U/week

Data type

boolean

Alias
UMLS CUI [1,1]
C1122087
UMLS CUI [1,2]
C1522438
UMLS CUI [1,3]
C0560588
must be treated with concomitant methotrexate (mtx) at a stable dose (oral or sc at any dose) for at least 12 weeks prior to screening visit
Description

Methotrexate Oral Dose Stable | Methotrexate Subcutaneous Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C1522438
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
3. subject must be in sustained clinical remission based on the following:
Description

Remission Clinical Sustained

Data type

boolean

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0443318
at least one documented disease activity score (das)28 erythrocyte sedimentation rate(esr) or das28 c-reactive protein (crp) < 2.6 (or calculated based on documented components of the das28) in the patient chart 6 months or longer prior to the screening visit
Description

DAS28 Patient chart | Erythrocyte sedimentation rate measurement Patient chart | C-reactive protein measurement Patient chart

Data type

boolean

Alias
UMLS CUI [1,1]
C4481729
UMLS CUI [1,2]
C1268547
UMLS CUI [2,1]
C1176468
UMLS CUI [2,2]
C1268547
UMLS CUI [3,1]
C0201657
UMLS CUI [3,2]
C1268547
das28 (esr) assessed at screening < 2.6, with all components including esr assessed at screening.
Description

DAS28 Screening | Erythrocyte sedimentation rate measurement Screening

Data type

boolean

Alias
UMLS CUI [1,1]
C4481729
UMLS CUI [1,2]
C0220908
UMLS CUI [2,1]
C1176468
UMLS CUI [2,2]
C0220908
4. if subjects are receiving concomitant conventional synthetic disease modifying anti-rheumatic drugs (csdmards) in addition to mtx, the dose must be stable for at least 12 weeks prior to the screening visit (e.g., chloroquine, hydroxychloroquine, sulfasalazine, gold formulations [including auranofin, gold sodium thiomalate, and aurothioglucose] and/or leflunomide).
Description

DMARDs synthetic conventional | Methotrexate Dose Stable | Chloroquine | Hydroxychloroquine | Sulfasalazine | Gold Formulation | Auranofin | Gold Sodium Thiomalate | Aurothioglucose | leflunomide

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1883254
UMLS CUI [1,3]
C0439858
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0008269
UMLS CUI [4]
C0020336
UMLS CUI [5]
C0036078
UMLS CUI [6,1]
C0018026
UMLS CUI [6,2]
C0524527
UMLS CUI [7]
C0004320
UMLS CUI [8]
C0018034
UMLS CUI [9]
C0018033
UMLS CUI [10]
C0063041
5. if subjects are receiving concomitant oral corticosteroids, prednisone or equivalent must be < 10 mg/day and the dose must be stable for at least 4 weeks prior to the screening visit.
Description

Adrenal Cortex Hormones Oral | Prednisone | Equivalent | Dose Stable U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0032952
UMLS CUI [3]
C0205163
UMLS CUI [4,1]
C0178602
UMLS CUI [4,2]
C0205360
UMLS CUI [4,3]
C0456683
6. if subjects are receiving non-steroidal anti-inflammatory drugs (nsaids) the dose must be stable for at least 4 weeks prior to the screening visit.
Description

NSAIDs Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
7. subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any das28 (esr) or das28 (crp) (or calculated based on documented components of the das28) assessed within 6 months prior to the screening visit ≥ 2.6
Description

DAS28 Time Interval | Erythrocyte sedimentation rate measurement Time Interval | C-reactive protein measurement Time Interval

Data type

boolean

Alias
UMLS CUI [1,1]
C4481729
UMLS CUI [1,2]
C0872291
UMLS CUI [2,1]
C1176468
UMLS CUI [2,2]
C0872291
UMLS CUI [3,1]
C0201657
UMLS CUI [3,2]
C0872291
2. subject is on an additional concomitant biological disease-modifying anti-rheumatic drug (bdmard) (including but not limited to abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab or tocilizumab).
Description

Biologic Disease-Modifying Antirheumatic Drug | abatacept | anakinra | certolizumab | Etanercept | golimumab | infliximab | rituximab | tocilizumab

Data type

boolean

Alias
UMLS CUI [1]
C4055380
UMLS CUI [2]
C1619966
UMLS CUI [3]
C0245109
UMLS CUI [4]
C1872109
UMLS CUI [5]
C0717758
UMLS CUI [6]
C2353893
UMLS CUI [7]
C0666743
UMLS CUI [8]
C0393022
UMLS CUI [9]
C1609165
3. subject has been treated with intra-articular or parenteral corticosteroids within the last four weeks before screening.
Description

Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Parenteral

Data type

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1518896
4. subject has undergone joint surgery within 12 weeks of screening (at joints to be assessed by magnetic resonance imaging (mri) and/or ultrasound).
Description

Operation on joint | Joint Assessment MRI | Joint Assessment Ultrasonography

Data type

boolean

Alias
UMLS CUI [1]
C0185132
UMLS CUI [2,1]
C0022417
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0024485
UMLS CUI [3,1]
C0022417
UMLS CUI [3,2]
C1516048
UMLS CUI [3,3]
C0041618
5. subject has a medical condition precluding an mri (e.g. magnetic activated implanted devices - cardiac pace-maker, insulin pump, neuro stimulators, etc. and metallic devices or fragments or clips in the eye, brain or spinal canal and in the hand/wrist undergoing mri)
Description

Medical condition Excludes MRI | Implanted device magnetic | Artificial cardiac pacemaker | Insulin pump | Neurostimulator | Metallic device | Fragment Eye | Clip Eye | Fragment Brain | Clip Brain | Fragment Spinal Canal | Clip Spinal Canal | Fragment Hand | Clip Hand | Fragment Wrist | Clip Wrist

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C0563532
UMLS CUI [3]
C0030163
UMLS CUI [4]
C1140609
UMLS CUI [5]
C0582124
UMLS CUI [6]
C3693688
UMLS CUI [7,1]
C0332255
UMLS CUI [7,2]
C0015392
UMLS CUI [8,1]
C0175722
UMLS CUI [8,2]
C0015392
UMLS CUI [9,1]
C0332255
UMLS CUI [9,2]
C0006104
UMLS CUI [10,1]
C0175722
UMLS CUI [10,2]
C0006104
UMLS CUI [11,1]
C0332255
UMLS CUI [11,2]
C0037922
UMLS CUI [12,1]
C0175722
UMLS CUI [12,2]
C0037922
UMLS CUI [13,1]
C0332255
UMLS CUI [13,2]
C0018563
UMLS CUI [14,1]
C0175722
UMLS CUI [14,2]
C0018563
UMLS CUI [15,1]
C0332255
UMLS CUI [15,2]
C0043262
UMLS CUI [16,1]
C0175722
UMLS CUI [16,2]
C0043262
6. subject has a medical condition precluding a contrast mri with gadolinium [e.g. nephrogenic systemic fibrosis, previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, pregnancy or breast feeding, severe renal insufficiency with an estimated glomerular filtration rate (egfr) below 0 ml/min/1.73m2 at screening, hepato-renal syndrome, severe chronic liver function impairment]
Description

Medical condition Excludes Nuclear magnetic resonance imaging gadolinium-enhanced | Nephrogenic Systemic Fibrosis | Anaphylaxis Gadolinium-based Contrast Agent | Anaphylactoid reaction Gadolinium-based Contrast Agent | Pregnancy | Breast Feeding | Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Hepatorenal Syndrome | Liver Dysfunction Severe chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0855566
UMLS CUI [2]
C3888044
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C3249258
UMLS CUI [4,1]
C0340865
UMLS CUI [4,2]
C3249258
UMLS CUI [5]
C0032961
UMLS CUI [6]
C0006147
UMLS CUI [7,1]
C1565489
UMLS CUI [7,2]
C0205082
UMLS CUI [8]
C3811844
UMLS CUI [9]
C0019212
UMLS CUI [10,1]
C0086565
UMLS CUI [10,2]
C0205082
UMLS CUI [10,3]
C0205191
7. subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the screening visit.
Description

Investigational New Drugs chemical | Investigational New Drugs biological

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0220806
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0205460
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Similar models

Eligibility Rheumatoid Arthritis NCT02198651

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
1. subject has a diagnosis of rheumatoid arthritis (ra) as defined by the 1987 revised american college of rheumatology (acr) classification criteria and/or the acr
boolean
C0003873 (UMLS CUI [1])
Classification Criteria
Item
/european league against rheumatism (eular) 2010 classification criteria (any duration since diagnosis).
boolean
C0008902 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Criteria Fulfill
Item
2. subject must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Adalimumab Subcutaneous U/week
Item
must be treated with adalimumab 40 mg sc eow for at least 12 months prior to screening visit
boolean
C1122087 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
Methotrexate Oral Dose Stable | Methotrexate Subcutaneous Dose Stable
Item
must be treated with concomitant methotrexate (mtx) at a stable dose (oral or sc at any dose) for at least 12 weeks prior to screening visit
boolean
C0025677 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0025677 (UMLS CUI [2,1])
C1522438 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Remission Clinical Sustained
Item
3. subject must be in sustained clinical remission based on the following:
boolean
C0544452 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0443318 (UMLS CUI [1,3])
DAS28 Patient chart | Erythrocyte sedimentation rate measurement Patient chart | C-reactive protein measurement Patient chart
Item
at least one documented disease activity score (das)28 erythrocyte sedimentation rate(esr) or das28 c-reactive protein (crp) < 2.6 (or calculated based on documented components of the das28) in the patient chart 6 months or longer prior to the screening visit
boolean
C4481729 (UMLS CUI [1,1])
C1268547 (UMLS CUI [1,2])
C1176468 (UMLS CUI [2,1])
C1268547 (UMLS CUI [2,2])
C0201657 (UMLS CUI [3,1])
C1268547 (UMLS CUI [3,2])
DAS28 Screening | Erythrocyte sedimentation rate measurement Screening
Item
das28 (esr) assessed at screening < 2.6, with all components including esr assessed at screening.
boolean
C4481729 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C1176468 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
DMARDs synthetic conventional | Methotrexate Dose Stable | Chloroquine | Hydroxychloroquine | Sulfasalazine | Gold Formulation | Auranofin | Gold Sodium Thiomalate | Aurothioglucose | leflunomide
Item
4. if subjects are receiving concomitant conventional synthetic disease modifying anti-rheumatic drugs (csdmards) in addition to mtx, the dose must be stable for at least 12 weeks prior to the screening visit (e.g., chloroquine, hydroxychloroquine, sulfasalazine, gold formulations [including auranofin, gold sodium thiomalate, and aurothioglucose] and/or leflunomide).
boolean
C0242708 (UMLS CUI [1,1])
C1883254 (UMLS CUI [1,2])
C0439858 (UMLS CUI [1,3])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0008269 (UMLS CUI [3])
C0020336 (UMLS CUI [4])
C0036078 (UMLS CUI [5])
C0018026 (UMLS CUI [6,1])
C0524527 (UMLS CUI [6,2])
C0004320 (UMLS CUI [7])
C0018034 (UMLS CUI [8])
C0018033 (UMLS CUI [9])
C0063041 (UMLS CUI [10])
Adrenal Cortex Hormones Oral | Prednisone | Equivalent | Dose Stable U/day
Item
5. if subjects are receiving concomitant oral corticosteroids, prednisone or equivalent must be < 10 mg/day and the dose must be stable for at least 4 weeks prior to the screening visit.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2])
C0205163 (UMLS CUI [3])
C0178602 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
NSAIDs Dose Stable
Item
6. if subjects are receiving non-steroidal anti-inflammatory drugs (nsaids) the dose must be stable for at least 4 weeks prior to the screening visit.
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Informed Consent | Protocol Compliance
Item
7. subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
DAS28 Time Interval | Erythrocyte sedimentation rate measurement Time Interval | C-reactive protein measurement Time Interval
Item
1. any das28 (esr) or das28 (crp) (or calculated based on documented components of the das28) assessed within 6 months prior to the screening visit ≥ 2.6
boolean
C4481729 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C1176468 (UMLS CUI [2,1])
C0872291 (UMLS CUI [2,2])
C0201657 (UMLS CUI [3,1])
C0872291 (UMLS CUI [3,2])
Biologic Disease-Modifying Antirheumatic Drug | abatacept | anakinra | certolizumab | Etanercept | golimumab | infliximab | rituximab | tocilizumab
Item
2. subject is on an additional concomitant biological disease-modifying anti-rheumatic drug (bdmard) (including but not limited to abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab or tocilizumab).
boolean
C4055380 (UMLS CUI [1])
C1619966 (UMLS CUI [2])
C0245109 (UMLS CUI [3])
C1872109 (UMLS CUI [4])
C0717758 (UMLS CUI [5])
C2353893 (UMLS CUI [6])
C0666743 (UMLS CUI [7])
C0393022 (UMLS CUI [8])
C1609165 (UMLS CUI [9])
Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Parenteral
Item
3. subject has been treated with intra-articular or parenteral corticosteroids within the last four weeks before screening.
boolean
C2064783 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
Operation on joint | Joint Assessment MRI | Joint Assessment Ultrasonography
Item
4. subject has undergone joint surgery within 12 weeks of screening (at joints to be assessed by magnetic resonance imaging (mri) and/or ultrasound).
boolean
C0185132 (UMLS CUI [1])
C0022417 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0022417 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
Medical condition Excludes MRI | Implanted device magnetic | Artificial cardiac pacemaker | Insulin pump | Neurostimulator | Metallic device | Fragment Eye | Clip Eye | Fragment Brain | Clip Brain | Fragment Spinal Canal | Clip Spinal Canal | Fragment Hand | Clip Hand | Fragment Wrist | Clip Wrist
Item
5. subject has a medical condition precluding an mri (e.g. magnetic activated implanted devices - cardiac pace-maker, insulin pump, neuro stimulators, etc. and metallic devices or fragments or clips in the eye, brain or spinal canal and in the hand/wrist undergoing mri)
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0021102 (UMLS CUI [2,1])
C0563532 (UMLS CUI [2,2])
C0030163 (UMLS CUI [3])
C1140609 (UMLS CUI [4])
C0582124 (UMLS CUI [5])
C3693688 (UMLS CUI [6])
C0332255 (UMLS CUI [7,1])
C0015392 (UMLS CUI [7,2])
C0175722 (UMLS CUI [8,1])
C0015392 (UMLS CUI [8,2])
C0332255 (UMLS CUI [9,1])
C0006104 (UMLS CUI [9,2])
C0175722 (UMLS CUI [10,1])
C0006104 (UMLS CUI [10,2])
C0332255 (UMLS CUI [11,1])
C0037922 (UMLS CUI [11,2])
C0175722 (UMLS CUI [12,1])
C0037922 (UMLS CUI [12,2])
C0332255 (UMLS CUI [13,1])
C0018563 (UMLS CUI [13,2])
C0175722 (UMLS CUI [14,1])
C0018563 (UMLS CUI [14,2])
C0332255 (UMLS CUI [15,1])
C0043262 (UMLS CUI [15,2])
C0175722 (UMLS CUI [16,1])
C0043262 (UMLS CUI [16,2])
Medical condition Excludes Nuclear magnetic resonance imaging gadolinium-enhanced | Nephrogenic Systemic Fibrosis | Anaphylaxis Gadolinium-based Contrast Agent | Anaphylactoid reaction Gadolinium-based Contrast Agent | Pregnancy | Breast Feeding | Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Hepatorenal Syndrome | Liver Dysfunction Severe chronic
Item
6. subject has a medical condition precluding a contrast mri with gadolinium [e.g. nephrogenic systemic fibrosis, previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, pregnancy or breast feeding, severe renal insufficiency with an estimated glomerular filtration rate (egfr) below 0 ml/min/1.73m2 at screening, hepato-renal syndrome, severe chronic liver function impairment]
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0855566 (UMLS CUI [1,3])
C3888044 (UMLS CUI [2])
C0002792 (UMLS CUI [3,1])
C3249258 (UMLS CUI [3,2])
C0340865 (UMLS CUI [4,1])
C3249258 (UMLS CUI [4,2])
C0032961 (UMLS CUI [5])
C0006147 (UMLS CUI [6])
C1565489 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C3811844 (UMLS CUI [8])
C0019212 (UMLS CUI [9])
C0086565 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0205191 (UMLS CUI [10,3])
Investigational New Drugs chemical | Investigational New Drugs biological
Item
7. subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the screening visit.
boolean
C0013230 (UMLS CUI [1,1])
C0220806 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0205460 (UMLS CUI [2,2])
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