ID

31267

Beschreibung

Adalimumab for Inflammatory Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00686439

Link

https://clinicaltrials.gov/show/NCT00686439

Stichworte

Versionen (1)
  1. 06.08.18 06.08.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

6. August 2018

DOI

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Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00686439

Englisch

Eligibility Osteoarthritis NCT00686439

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is 40 years of age or older.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
if female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (iud) contraceptives (oral or parenteral) for three months prior to study drug administration),a vasectomized partner, total abstinence from sexual intercourse
Beschreibung

Postmenopausal state | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Childbearing Potential Contraceptive methods | Female Condoms | Contraceptive Sponge | Vaginal Foam Contraceptive | Vaginal Gel Contraceptive | Vaginal contraceptive diaphragm | Intrauterine Devices | Contraceptives, Oral | Contraceptive Agents Parenteral | Partner had vasectomy | Sexual Abstinence

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0589114
UMLS CUI [4]
C0278321
UMLS CUI [5]
C0020699
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0700589
UMLS CUI [7]
C0221829
UMLS CUI [8]
C0183461
UMLS CUI [9,1]
C0042254
UMLS CUI [9,2]
C0009871
UMLS CUI [10,1]
C0042257
UMLS CUI [10,2]
C0009871
UMLS CUI [11]
C0042241
UMLS CUI [12]
C0021900
UMLS CUI [13]
C0009905
UMLS CUI [14,1]
C0009871
UMLS CUI [14,2]
C1518896
UMLS CUI [15]
C0420842
UMLS CUI [16]
C0036899
if patient is female and of childbearing potential, the results of a serum pregnancy test performed at screening, prior to the first dose of adalimumab, must be negative.
Beschreibung

Childbearing Potential Serum pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
patient has a diagnosis of oa of the index knee according to american college of rheumatology criteria, including radiological evidence of oa (kellgren-lawrence grades 2 or 3).
Beschreibung

Osteoarthritis, Knee | Osteoarthritis Kellgren-Lawrence score Radiology

Datentyp

boolean

Alias
UMLS CUI [1]
C0409959
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C3177117
UMLS CUI [2,3]
C0043299
patient has had continual pain for at least 6 months prior to inclusion in the study. this includes pain that has persisted despite conventional treatment, defined as any one of the following medications taken daily during the preceding month:acetaminophen (2- 4 grams per day)maximum tolerated and recommended doses of an nsaid, acetaminophen/codeine combination (i.e. tylenol no 2, 3, 4) taken at least 3 times daily
Beschreibung

Pain Duration | Pain Persistent Conventional Treatment Resistant | Acetaminophen U/day | NSAIDs Maximum Tolerated Dose | Acetaminophen / Codeine Times Daily | Tylenol Times Daily

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0205322
UMLS CUI [2,3]
C2945704
UMLS CUI [2,4]
C0332325
UMLS CUI [3,1]
C0000970
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0003211
UMLS CUI [4,2]
C0752079
UMLS CUI [5,1]
C2351132
UMLS CUI [5,2]
C1632851
UMLS CUI [5,3]
C0332173
UMLS CUI [6,1]
C0699142
UMLS CUI [6,2]
C1632851
UMLS CUI [6,3]
C0332173
patient has had daily knee pain for the month preceding study enrolment.
Beschreibung

Knee pain Daily

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0332173
patient has a summed pain score of 125-400mm (visual analog scale) on the womac pain sub-scale in the index (more symptomatic) knee.
Beschreibung

Index Knee Visual Analog Pain Scale | Index Knee WOMAC scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0042815
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C3472647
patient has clinical evidence of a knee effusion in the index (more symptomatic) knee at screening and baseline.
Beschreibung

Knee effusion Index Knee

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0343166
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022742
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a history of an allergic reaction or significant sensitivity to constituents of adalimumab.
Beschreibung

Allergic Reaction Adalimumab Constituents | Hypersensitivity Adalimumab Constituents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1122087
UMLS CUI [1,3]
C0729650
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1122087
UMLS CUI [2,3]
C0729650
patient has a history of proven systemic arthritis such as rheumatoid arthritis.
Beschreibung

Arthritis Systemic | Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0003873
patient has a concurrent medical or arthritic condition that could confound evaluation of the index joint e.g. post-traumatic or any secondary form of knee oa
Beschreibung

Medical condition Interferes with Evaluation Index Joint | Arthritis Interferes with Evaluation Index Joint | Knee Osteoarthritis Posttraumatic | Secondary osteoarthritis of knee

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C2986546
UMLS CUI [1,5]
C0022417
UMLS CUI [2,1]
C0003864
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C2986546
UMLS CUI [2,5]
C0022417
UMLS CUI [3,1]
C0409959
UMLS CUI [3,2]
C0231288
UMLS CUI [4]
C2893943
patient has predominant patellofemoral disease
Beschreibung

Disorder of patellofemoral joint Predominant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0409325
UMLS CUI [1,2]
C1542147
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Ähnliche Modelle

Eligibility Osteoarthritis NCT00686439

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is 40 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Childbearing Potential Contraceptive methods | Female Condoms | Contraceptive Sponge | Vaginal Foam Contraceptive | Vaginal Gel Contraceptive | Vaginal contraceptive diaphragm | Intrauterine Devices | Contraceptives, Oral | Contraceptive Agents Parenteral | Partner had vasectomy | Sexual Abstinence
Item
if female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (iud) contraceptives (oral or parenteral) for three months prior to study drug administration),a vasectomized partner, total abstinence from sexual intercourse
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0589114 (UMLS CUI [3])
C0278321 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0221829 (UMLS CUI [7])
C0183461 (UMLS CUI [8])
C0042254 (UMLS CUI [9,1])
C0009871 (UMLS CUI [9,2])
C0042257 (UMLS CUI [10,1])
C0009871 (UMLS CUI [10,2])
C0042241 (UMLS CUI [11])
C0021900 (UMLS CUI [12])
C0009905 (UMLS CUI [13])
C0009871 (UMLS CUI [14,1])
C1518896 (UMLS CUI [14,2])
C0420842 (UMLS CUI [15])
C0036899 (UMLS CUI [16])
Childbearing Potential Serum pregnancy test negative
Item
if patient is female and of childbearing potential, the results of a serum pregnancy test performed at screening, prior to the first dose of adalimumab, must be negative.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Osteoarthritis, Knee | Osteoarthritis Kellgren-Lawrence score Radiology
Item
patient has a diagnosis of oa of the index knee according to american college of rheumatology criteria, including radiological evidence of oa (kellgren-lawrence grades 2 or 3).
boolean
C0409959 (UMLS CUI [1])
C0029408 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
C0043299 (UMLS CUI [2,3])
Pain Duration | Pain Persistent Conventional Treatment Resistant | Acetaminophen U/day | NSAIDs Maximum Tolerated Dose | Acetaminophen / Codeine Times Daily | Tylenol Times Daily
Item
patient has had continual pain for at least 6 months prior to inclusion in the study. this includes pain that has persisted despite conventional treatment, defined as any one of the following medications taken daily during the preceding month:acetaminophen (2- 4 grams per day)maximum tolerated and recommended doses of an nsaid, acetaminophen/codeine combination (i.e. tylenol no 2, 3, 4) taken at least 3 times daily
boolean
C0030193 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C2945704 (UMLS CUI [2,3])
C0332325 (UMLS CUI [2,4])
C0000970 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0003211 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C2351132 (UMLS CUI [5,1])
C1632851 (UMLS CUI [5,2])
C0332173 (UMLS CUI [5,3])
C0699142 (UMLS CUI [6,1])
C1632851 (UMLS CUI [6,2])
C0332173 (UMLS CUI [6,3])
Knee pain Daily
Item
patient has had daily knee pain for the month preceding study enrolment.
boolean
C0231749 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
Index Knee Visual Analog Pain Scale | Index Knee WOMAC scale
Item
patient has a summed pain score of 125-400mm (visual analog scale) on the womac pain sub-scale in the index (more symptomatic) knee.
boolean
C2986546 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0042815 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C3472647 (UMLS CUI [2,3])
Knee effusion Index Knee
Item
patient has clinical evidence of a knee effusion in the index (more symptomatic) knee at screening and baseline.
boolean
C0343166 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Adalimumab Constituents | Hypersensitivity Adalimumab Constituents
Item
subject has a history of an allergic reaction or significant sensitivity to constituents of adalimumab.
boolean
C1527304 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
C0729650 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1122087 (UMLS CUI [2,2])
C0729650 (UMLS CUI [2,3])
Arthritis Systemic | Rheumatoid Arthritis
Item
patient has a history of proven systemic arthritis such as rheumatoid arthritis.
boolean
C0003864 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
Medical condition Interferes with Evaluation Index Joint | Arthritis Interferes with Evaluation Index Joint | Knee Osteoarthritis Posttraumatic | Secondary osteoarthritis of knee
Item
patient has a concurrent medical or arthritic condition that could confound evaluation of the index joint e.g. post-traumatic or any secondary form of knee oa
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C2986546 (UMLS CUI [1,4])
C0022417 (UMLS CUI [1,5])
C0003864 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C2986546 (UMLS CUI [2,4])
C0022417 (UMLS CUI [2,5])
C0409959 (UMLS CUI [3,1])
C0231288 (UMLS CUI [3,2])
C2893943 (UMLS CUI [4])
Disorder of patellofemoral joint Predominant
Item
patient has predominant patellofemoral disease
boolean
C0409325 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
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