ID

22971

Description

A Phase II Dose-finding Study of Atacicept in Rheumatoid Arthritis (RA); ODM derived from: https://clinicaltrials.gov/show/NCT00430495

Link

https://clinicaltrials.gov/show/NCT00430495

Keywords

Versions (1)
  1. 6/19/17 6/19/17 -
Uploaded on

June 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00430495

English

Eligibility Rheumatoid Arthritis NCT00430495

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. rheumatoid arthritis satisfying year american college of rheumatology (acr) diagnostic criteria with a disease history of at least one year.
Description

Rheumatoid Arthritis disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
2. male or female greater than or equal to 18 years of age at time of informed consent.
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
3. active ra as defined by:
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
greater than or equal to swollen joints (66-joint count),
Description

Swollen joint count

Data type

boolean

Alias
UMLS CUI [1]
C0451521
greater than or equal to tender joints (68-joint count), and
Description

Tender joint count

Data type

boolean

Alias
UMLS CUI [1]
C0451530
crp greater than or equal to 10 mg/l (central laboratory) and/or esr greater than or equal to 28mm/h.
Description

C-reactive protein measurement | Erythrocyte sedimentation rate measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201657
UMLS CUI [2]
C1176468
4. failure of at least one tnfa antagonist therapy (previously or at the time of screening)
Description

Tumor Necrosis Factor-alpha Antagonists Quantity failed

Data type

boolean

Alias
UMLS CUI [1,1]
C1456820
UMLS CUI [1,2]
C0243076
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231175
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the investigator constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation.
Description

Condition At risk Study Subject Participation Status | Laboratory Results At risk Study Subject Participation Status | Medical History At risk Study Subject Participation Status | Medical contraindication Study Subject Participation Status | Condition Interferes with Study Protocol | Condition Interferes with Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C2348568
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348563
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1261322
2. treatment with biologics aiming at b cell modulation such as rituximab (also called rituxan), a cancer and arthritis drug) or belimumab within 2 years before sd 1.
Description

Biological treatment targeting B-Lymphocytes Modulation | rituximab | Rituxan | Antineoplastic Agents | Pharmaceutical Preparations Against Arthritis | belimumab

Data type

boolean

Alias
UMLS CUI [1,1]
C1531518
UMLS CUI [1,2]
C0599894
UMLS CUI [1,3]
C0004561
UMLS CUI [1,4]
C0544633
UMLS CUI [2]
C0393022
UMLS CUI [3]
C0732355
UMLS CUI [4]
C0003392
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0521124
UMLS CUI [5,3]
C0003864
UMLS CUI [6]
C1723401
3. any previous treatment with anakinra (kineret), abatacept (orencia) or tocilizumab within 3 months before sd1.
Description

anakinra | Kineret | abatacept | Orencia | tocilizumab

Data type

boolean

Alias
UMLS CUI [1]
C0245109
UMLS CUI [2]
C1170364
UMLS CUI [3]
C1619966
UMLS CUI [4]
C1700021
UMLS CUI [5]
C1609165
4. use of etanercept (enbrel) within 28 days before sd 1, or of infliximab (remicade) or adalimumab (humira) within 60 days before sd 1.
Description

Etanercept | Enbrel | infliximab | Remicade | adalimumab | Humira

Data type

boolean

Alias
UMLS CUI [1]
C0717758
UMLS CUI [2]
C0720193
UMLS CUI [3]
C0666743
UMLS CUI [4]
C0723012
UMLS CUI [5]
C1122087
UMLS CUI [6]
C1171255
5. participation in any interventional clinical trial with an unapproved investigational therapy within the 3 months before the start of this study (or within 5 half-lives of the investigated compound before study day 1, whichever is longer).
Description

Study Subject Participation Status | Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
children are necessarily excluded from this study.
Description

Children

Data type

boolean

Alias
UMLS CUI [1]
C0008059
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Similar models

Eligibility Rheumatoid Arthritis NCT00430495

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis disease length
Item
1. rheumatoid arthritis satisfying year american college of rheumatology (acr) diagnostic criteria with a disease history of at least one year.
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age | Informed Consent
Item
2. male or female greater than or equal to 18 years of age at time of informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Rheumatoid Arthritis
Item
3. active ra as defined by:
boolean
C0003873 (UMLS CUI [1])
Swollen joint count
Item
greater than or equal to swollen joints (66-joint count),
boolean
C0451521 (UMLS CUI [1])
Tender joint count
Item
greater than or equal to tender joints (68-joint count), and
boolean
C0451530 (UMLS CUI [1])
C-reactive protein measurement | Erythrocyte sedimentation rate measurement
Item
crp greater than or equal to 10 mg/l (central laboratory) and/or esr greater than or equal to 28mm/h.
boolean
C0201657 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
Tumor Necrosis Factor-alpha Antagonists Quantity failed
Item
4. failure of at least one tnfa antagonist therapy (previously or at the time of screening)
boolean
C1456820 (UMLS CUI [1,1])
C0243076 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Condition At risk Study Subject Participation Status | Laboratory Results At risk Study Subject Participation Status | Medical History At risk Study Subject Participation Status | Medical contraindication Study Subject Participation Status | Condition Interferes with Study Protocol | Condition Interferes with Evaluation
Item
1. any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the investigator constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation.
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1254595 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348563 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
Biological treatment targeting B-Lymphocytes Modulation | rituximab | Rituxan | Antineoplastic Agents | Pharmaceutical Preparations Against Arthritis | belimumab
Item
2. treatment with biologics aiming at b cell modulation such as rituximab (also called rituxan), a cancer and arthritis drug) or belimumab within 2 years before sd 1.
boolean
C1531518 (UMLS CUI [1,1])
C0599894 (UMLS CUI [1,2])
C0004561 (UMLS CUI [1,3])
C0544633 (UMLS CUI [1,4])
C0393022 (UMLS CUI [2])
C0732355 (UMLS CUI [3])
C0003392 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0521124 (UMLS CUI [5,2])
C0003864 (UMLS CUI [5,3])
C1723401 (UMLS CUI [6])
anakinra | Kineret | abatacept | Orencia | tocilizumab
Item
3. any previous treatment with anakinra (kineret), abatacept (orencia) or tocilizumab within 3 months before sd1.
boolean
C0245109 (UMLS CUI [1])
C1170364 (UMLS CUI [2])
C1619966 (UMLS CUI [3])
C1700021 (UMLS CUI [4])
C1609165 (UMLS CUI [5])
Etanercept | Enbrel | infliximab | Remicade | adalimumab | Humira
Item
4. use of etanercept (enbrel) within 28 days before sd 1, or of infliximab (remicade) or adalimumab (humira) within 60 days before sd 1.
boolean
C0717758 (UMLS CUI [1])
C0720193 (UMLS CUI [2])
C0666743 (UMLS CUI [3])
C0723012 (UMLS CUI [4])
C1122087 (UMLS CUI [5])
C1171255 (UMLS CUI [6])
Study Subject Participation Status | Therapy, Investigational
Item
5. participation in any interventional clinical trial with an unapproved investigational therapy within the 3 months before the start of this study (or within 5 half-lives of the investigated compound before study day 1, whichever is longer).
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Children
Item
children are necessarily excluded from this study.
boolean
C0008059 (UMLS CUI [1])
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