ID

37152

Beschreibung

Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study; ODM derived from: https://clinicaltrials.gov/show/NCT02433340

Link

https://clinicaltrials.gov/show/NCT02433340

Stichworte

Versionen (1)
  1. 04.07.19 04.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. Juli 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02433340

Englisch

Eligibility Rheumatoid Arthritis NCT02433340

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects who have completed the preceding study m12-963 (abt-122) rct study and have not developed any discontinuation criteria, as defined in section 5.4.1 of study m12-963.
Beschreibung

Clinical Trial Preceding Completed | ABT-122 | Discontinuation Criteria Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C4547412
UMLS CUI [3,1]
C1444662
UMLS CUI [3,2]
C0243161
UMLS CUI [3,3]
C0332197
2. if female, subject must meet one of the following criteria:
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
postmenopausal (defined as no menses for at least 1 year).
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
Beschreibung

Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0589114
UMLS CUI [3]
C0278321
UMLS CUI [4]
C0020699
practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug. females who have undergone tubal ligation will be required to agree to use a second form of contraception for the same period of time.
Beschreibung

Contraceptive methods | Tubal Ligation Requirement Contraceptive method second

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C0520483
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C0205436
3. male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
Beschreibung

Gender Contraceptive methods | Omission Sperm donation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3845736
UMLS CUI [2,2]
C0871414
4. subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee (iec)/institutional review board (irb), prior to the initiation of any screening or study-specific procedures.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
5. subject is judged to be in good health as determined by the investigator based on the results of medical history, physical examination and laboratory profile performed.
Beschreibung

Good health Medical History | Good health Physical Examination | Good health Laboratory Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3813622
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3813622
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C3813622
UMLS CUI [3,2]
C0022885
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or breastfeeding female.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. ongoing infections at day 1 (week 0) that have not been successfully treated within 14 days.
Beschreibung

Communicable Diseases | Therapy Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1272705
3. anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
Beschreibung

Requirement Anticipated Live Vaccine | Live Vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C3840775
UMLS CUI [1,3]
C0042211
UMLS CUI [2]
C0042211
4. current enrollment in another investigational study; with the exception of study m12-963, which is required.
Beschreibung

Study Subject Participation Status | Clinical study | Exception Clinical Trial Specified

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008972
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0008976
UMLS CUI [3,3]
C0205369
5. consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive abt-122.
Beschreibung

Study Subject Inappropriate ABT-122

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C4547412
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT02433340

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Preceding Completed | ABT-122 | Discontinuation Criteria Absent
Item
1. subjects who have completed the preceding study m12-963 (abt-122) rct study and have not developed any discontinuation criteria, as defined in section 5.4.1 of study m12-963.
boolean
C0008976 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C4547412 (UMLS CUI [2])
C1444662 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Gender
Item
2. if female, subject must meet one of the following criteria:
boolean
C0079399 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal (defined as no menses for at least 1 year).
boolean
C0232970 (UMLS CUI [1])
Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy
Item
surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
boolean
C0015787 (UMLS CUI [1])
C0589114 (UMLS CUI [2])
C0278321 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
Contraceptive methods | Tubal Ligation Requirement Contraceptive method second
Item
practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug. females who have undergone tubal ligation will be required to agree to use a second form of contraception for the same period of time.
boolean
C0700589 (UMLS CUI [1])
C0520483 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0205436 (UMLS CUI [2,4])
Gender Contraceptive methods | Omission Sperm donation
Item
3. male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3845736 (UMLS CUI [2,1])
C0871414 (UMLS CUI [2,2])
Informed Consent
Item
4. subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee (iec)/institutional review board (irb), prior to the initiation of any screening or study-specific procedures.
boolean
C0021430 (UMLS CUI [1])
Good health Medical History | Good health Physical Examination | Good health Laboratory Procedures
Item
5. subject is judged to be in good health as determined by the investigator based on the results of medical history, physical examination and laboratory profile performed.
boolean
C3813622 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3813622 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3813622 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or breastfeeding female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Communicable Diseases | Therapy Unsuccessful
Item
2. ongoing infections at day 1 (week 0) that have not been successfully treated within 14 days.
boolean
C0009450 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Requirement Anticipated Live Vaccine | Live Vaccine
Item
3. anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
boolean
C1514873 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0042211 (UMLS CUI [1,3])
C0042211 (UMLS CUI [2])
Study Subject Participation Status | Clinical study | Exception Clinical Trial Specified
Item
4. current enrollment in another investigational study; with the exception of study m12-963, which is required.
boolean
C2348568 (UMLS CUI [1])
C0008972 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Study Subject Inappropriate ABT-122
Item
5. consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive abt-122.
boolean
C0681850 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C4547412 (UMLS CUI [1,3])
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