ID

31854

Description

A Study of ARRY-371797 in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00729209

Lien

https://clinicaltrials.gov/show/NCT00729209

Mots-clés

Versions (1)
  1. 04/10/2018 04/10/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 octobre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00729209

Anglais

Eligibility Rheumatoid Arthritis NCT00729209

1 Formulaires  
Criteria
Description

Criteria

diagnosed with rheumatoid arthritis (ra) at least 3 months prior to study start based upon the american college of rheumatology (acr) 1987 revised criteria.
Description

Rheumatoid Arthritis

Type de données

boolean

Alias
UMLS CUI [1]
C0003873
on a stable weekly dose of both methotrexate (mtx) (10 - 25 mg/week inclusively; either oral or parenteral) and folate (≥ 5 mg weekly ) for ≥ 6 weeks prior to study start and is willing to continue on these regimens for the duration of the study.
Description

Methotrexate Oral Product Dose Stable U/week | Methotrexate Injectable Product Dose Stable U/week | Folate U/week

Type de données

boolean

Alias
UMLS CUI [1,1]
C3216566
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
UMLS CUI [2,1]
C3216565
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0560588
UMLS CUI [3,1]
C0178638
UMLS CUI [3,2]
C0560588
meets the acr 1991 revised criteria for global functional status in ra, class i, ii, or iii.
Description

Rheumatoid Arthritis Functional Status Class

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
completed an appropriate washout period if treated with specified therapies.
Description

Therapeutic procedure Specified | Washout Period Completed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0205197
patients may continue on specified stable background therapy for ra (doses should be stable for at least 6 weeks prior to the first dose of study drug, unless the patient stops due to documented disease improvement, with sponsor approval).
Description

Standard of Care Dose Stable Rheumatoid Arthritis

Type de données

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0003873
additional criteria exist.
Description

Inclusion criteria Additional

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
key exclusion criteria:
Description

Exclusion Criteria Main

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
diagnosis of any other inflammatory or non-inflammatory arthritis (e.g. spondyloarthritis; fibromyalgia, psoriatic arthritis, crystal-proven gout) that may interfere with disease activity assessments and/or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
Description

Arthritis Interferes with Assessment of disease activity | Arthritis Noninflammatory Interferes with Assessment of disease activity | Spondylarthritis | Fibromyalgia | Arthritis, Psoriatic | Gout | Osteoarthritis Affecting Evaluation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C4064989
UMLS CUI [2,1]
C0003864
UMLS CUI [2,2]
C0442743
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C4064989
UMLS CUI [3]
C0949690
UMLS CUI [4]
C0016053
UMLS CUI [5]
C0003872
UMLS CUI [6]
C0018099
UMLS CUI [7,1]
C0029408
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C0220825
has received any of the following prior treatments:
Description

Prior Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C1514463
1. within 4 weeks of first dose of study drug: anakinra (kineret®), etanercept (enbrel®);
Description

anakinra | Kineret | Etanercept | Enbrel

Type de données

boolean

Alias
UMLS CUI [1]
C0245109
UMLS CUI [2]
C1170364
UMLS CUI [3]
C0717758
UMLS CUI [4]
C0720193
2. within 8 weeks of first dose of study drug: infliximab (remicade®), adalimumab (humira®), leflunomide (arava®);
Description

infliximab | Remicade | adalimumab | Humira | leflunomide | Arava

Type de données

boolean

Alias
UMLS CUI [1]
C0666743
UMLS CUI [2]
C0723012
UMLS CUI [3]
C1122087
UMLS CUI [4]
C1171255
UMLS CUI [5]
C0063041
UMLS CUI [6]
C0718644
3. at any time: rituximab (rituxan®), alemtuzumab (campath®), any experimental b cell targeting agents.
Description

rituximab | Rituxan | alemtuzumab | Campath | Investigational New Drugs Targeting B cells

Type de données

boolean

Alias
UMLS CUI [1]
C0393022
UMLS CUI [2]
C0732355
UMLS CUI [3]
C0383429
UMLS CUI [4]
C0939276
UMLS CUI [5,1]
C0013230
UMLS CUI [5,2]
C1521840
UMLS CUI [5,3]
C0004561
treatment with potent cyp3a inhibitors or inducers, disease-modifying antirheumatic drugs (dmards) and/or biologic response modifiers (brms) during the study.
Description

CYP3A Inhibitors | CYP3A Inducers | Antirheumatic Drugs, Disease-Modifying | Biological Response Modifiers

Type de données

boolean

Alias
UMLS CUI [1]
C3850056
UMLS CUI [2]
C3850044
UMLS CUI [3]
C0242708
UMLS CUI [4]
C0005525
additional criteria exist.
Description

Exclusion Criteria Additional

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Rheumatoid Arthritis NCT00729209

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Rheumatoid Arthritis
Item
diagnosed with rheumatoid arthritis (ra) at least 3 months prior to study start based upon the american college of rheumatology (acr) 1987 revised criteria.
boolean
C0003873 (UMLS CUI [1])
Methotrexate Oral Product Dose Stable U/week | Methotrexate Injectable Product Dose Stable U/week | Folate U/week
Item
on a stable weekly dose of both methotrexate (mtx) (10 - 25 mg/week inclusively; either oral or parenteral) and folate (≥ 5 mg weekly ) for ≥ 6 weeks prior to study start and is willing to continue on these regimens for the duration of the study.
boolean
C3216566 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
C3216565 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0560588 (UMLS CUI [2,4])
C0178638 (UMLS CUI [3,1])
C0560588 (UMLS CUI [3,2])
Rheumatoid Arthritis Functional Status Class
Item
meets the acr 1991 revised criteria for global functional status in ra, class i, ii, or iii.
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Therapeutic procedure Specified | Washout Period Completed
Item
completed an appropriate washout period if treated with specified therapies.
boolean
C0087111 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1710661 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Standard of Care Dose Stable Rheumatoid Arthritis
Item
patients may continue on specified stable background therapy for ra (doses should be stable for at least 6 weeks prior to the first dose of study drug, unless the patient stops due to documented disease improvement, with sponsor approval).
boolean
C2936643 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003873 (UMLS CUI [1,4])
Inclusion criteria Additional
Item
additional criteria exist.
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Arthritis Interferes with Assessment of disease activity | Arthritis Noninflammatory Interferes with Assessment of disease activity | Spondylarthritis | Fibromyalgia | Arthritis, Psoriatic | Gout | Osteoarthritis Affecting Evaluation
Item
diagnosis of any other inflammatory or non-inflammatory arthritis (e.g. spondyloarthritis; fibromyalgia, psoriatic arthritis, crystal-proven gout) that may interfere with disease activity assessments and/or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
boolean
C0003864 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C4064989 (UMLS CUI [1,3])
C0003864 (UMLS CUI [2,1])
C0442743 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C4064989 (UMLS CUI [2,4])
C0949690 (UMLS CUI [3])
C0016053 (UMLS CUI [4])
C0003872 (UMLS CUI [5])
C0018099 (UMLS CUI [6])
C0029408 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0220825 (UMLS CUI [7,3])
Prior Therapy
Item
has received any of the following prior treatments:
boolean
C1514463 (UMLS CUI [1])
anakinra | Kineret | Etanercept | Enbrel
Item
1. within 4 weeks of first dose of study drug: anakinra (kineret®), etanercept (enbrel®);
boolean
C0245109 (UMLS CUI [1])
C1170364 (UMLS CUI [2])
C0717758 (UMLS CUI [3])
C0720193 (UMLS CUI [4])
infliximab | Remicade | adalimumab | Humira | leflunomide | Arava
Item
2. within 8 weeks of first dose of study drug: infliximab (remicade®), adalimumab (humira®), leflunomide (arava®);
boolean
C0666743 (UMLS CUI [1])
C0723012 (UMLS CUI [2])
C1122087 (UMLS CUI [3])
C1171255 (UMLS CUI [4])
C0063041 (UMLS CUI [5])
C0718644 (UMLS CUI [6])
rituximab | Rituxan | alemtuzumab | Campath | Investigational New Drugs Targeting B cells
Item
3. at any time: rituximab (rituxan®), alemtuzumab (campath®), any experimental b cell targeting agents.
boolean
C0393022 (UMLS CUI [1])
C0732355 (UMLS CUI [2])
C0383429 (UMLS CUI [3])
C0939276 (UMLS CUI [4])
C0013230 (UMLS CUI [5,1])
C1521840 (UMLS CUI [5,2])
C0004561 (UMLS CUI [5,3])
CYP3A Inhibitors | CYP3A Inducers | Antirheumatic Drugs, Disease-Modifying | Biological Response Modifiers
Item
treatment with potent cyp3a inhibitors or inducers, disease-modifying antirheumatic drugs (dmards) and/or biologic response modifiers (brms) during the study.
boolean
C3850056 (UMLS CUI [1])
C3850044 (UMLS CUI [2])
C0242708 (UMLS CUI [3])
C0005525 (UMLS CUI [4])
Exclusion Criteria Additional
Item
additional criteria exist.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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