ID

35883

Description

A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02384538

Link

https://clinicaltrials.gov/show/NCT02384538

Keywords

Versions (1)
  1. 4/1/19 4/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 1, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hand Osteoarthritis NCT02384538

English

Eligibility Hand Osteoarthritis NCT02384538

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female between the ages of 35 to 80.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. must fulfill 1990 american college of rheumatology (acr) hand osteoarthritis (oa) criteria
Description

Osteoarthritis of the hand Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0263746
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
3. must have radiographic evidence of erosive hand oa
Description

Erosive osteoarthritis Hand Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0451840
UMLS CUI [1,2]
C0018563
UMLS CUI [1,3]
C0034571
4. have one or more clinical signs and symptoms of active inflammation in at least three hand joints
Description

Signs and Symptoms Arthritis of joint of hand Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0409208
UMLS CUI [1,3]
C1265611
5. subject assessment of hand pain intensity in at least one hand is ≥ 6.
Description

Hand Pain intensity Assessment Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0018563
UMLS CUI [1,2]
C1320357
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0449820
6. patient global assessment of arthritis status is ≥ 6.
Description

Global assessment Arthritis Status Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0281858
UMLS CUI [1,2]
C0003864
UMLS CUI [1,3]
C0449438
UMLS CUI [1,4]
C0449820
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous exposure to any anti-interleukin-1 treatment, to corticosteroids within 1 month prior to screening, to intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to screening, to any immunosuppressive biologic therapy within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug, or current use of immunosuppressive oral medications within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug.
Description

Exposure to Interleukin 1 Receptor Antagonists | Exposure to Adrenal Cortex Hormones | INTRAARTICULAR HYALURONIC ACID Injection Hand joint | Therapeutic immunosuppression biological | Immunosuppressive Agents Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C2917260
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0001617
UMLS CUI [3,1]
C0493951
UMLS CUI [3,2]
C1533685
UMLS CUI [3,3]
C0459470
UMLS CUI [4,1]
C0021079
UMLS CUI [4,2]
C0205460
UMLS CUI [5,1]
C0021081
UMLS CUI [5,2]
C1527415
2. absolute neutrophil count < 2,000 mm3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
3. diagnosis of one or more of the following:
Description

Diagnosis Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1265611
fibromyalgia,
Description

Fibromyalgia

Data type

boolean

Alias
UMLS CUI [1]
C0016053
inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy,
Description

Arthritis | Rheumatoid Arthritis | Spondylarthropathy Peripheral Seronegative

Data type

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0003873
UMLS CUI [3,1]
C0949691
UMLS CUI [3,2]
C0205100
UMLS CUI [3,3]
C0521144
psoriatic arthritis, psoriasis,
Description

Arthritis, Psoriatic | Psoriasis

Data type

boolean

Alias
UMLS CUI [1]
C0003872
UMLS CUI [2]
C0033860
microcrystalline (including gout and pseudo gout) arthritis affecting the hands,
Description

Crystal Arthropathy Affecting Hands | Gout | Pseudogout

Data type

boolean

Alias
UMLS CUI [1,1]
C0152087
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0018563
UMLS CUI [2]
C0018099
UMLS CUI [3]
C0033802
any oa of the hands due to an infectious origin or acute traumatic episode, secondary oa or oa linked to cartilage and bone dysplasia,
Description

Osteoarthritis of the hand Due to Communicable Disease | Osteoarthritis of the hand Due to Episode Traumatic | Secondary osteoarthritis | Osteoarthritis Relationship Cartilage dysplasia | Osteoarthritis Relationship Bone dysplasia

Data type

boolean

Alias
UMLS CUI [1,1]
C0263746
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0009450
UMLS CUI [2,1]
C0263746
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0332189
UMLS CUI [2,4]
C0332663
UMLS CUI [3]
C2732281
UMLS CUI [4,1]
C0029408
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C0007301
UMLS CUI [4,4]
C0334044
UMLS CUI [5,1]
C0029408
UMLS CUI [5,2]
C0439849
UMLS CUI [5,3]
C0005941
other chronic painful syndromes that could interfere with assessment of pain at the hand(s).
Description

Chronic pain syndrome Interferes with Assessment Hand pain

Data type

boolean

Alias
UMLS CUI [1,1]
C1298685
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0239833
4. any uncontrolled medical illness or an unstable treatment or therapy.
Description

Illness Uncontrolled | Therapy Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0443343
5. clinically significant cardiac disease.
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
6. evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
Description

Dysplasia | Malignant Neoplasms | Exception Squamous cell carcinoma of skin Treated | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Localized

Data type

boolean

Alias
UMLS CUI [1]
C0334044
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C0392752
7. history of persistent chronic or active infection(s) requiring hospitalization or treatment with antimicrobials/antibiotics.
Description

Chronic infectious disease Persistent Hospitalization Required | Communicable Disease Hospitalization Required | Microbicides | Antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0151317
UMLS CUI [1,2]
C0205322
UMLS CUI [1,3]
C1708385
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1708385
UMLS CUI [3]
C1136254
UMLS CUI [4]
C0003232
8. any reason that prohibits a subject to undergo an mri.
Description

Reason Preventing MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0024485
Back to the top of the page

Similar models

Eligibility Hand Osteoarthritis NCT02384538

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female between the ages of 35 to 80.
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis of the hand Criteria Fulfill
Item
2. must fulfill 1990 american college of rheumatology (acr) hand osteoarthritis (oa) criteria
boolean
C0263746 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Erosive osteoarthritis Hand Radiography
Item
3. must have radiographic evidence of erosive hand oa
boolean
C0451840 (UMLS CUI [1,1])
C0018563 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
Signs and Symptoms Arthritis of joint of hand Quantity
Item
4. have one or more clinical signs and symptoms of active inflammation in at least three hand joints
boolean
C0037088 (UMLS CUI [1,1])
C0409208 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Hand Pain intensity Assessment Score
Item
5. subject assessment of hand pain intensity in at least one hand is ≥ 6.
boolean
C0018563 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
Global assessment Arthritis Status Score
Item
6. patient global assessment of arthritis status is ≥ 6.
boolean
C0281858 (UMLS CUI [1,1])
C0003864 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Exposure to Interleukin 1 Receptor Antagonists | Exposure to Adrenal Cortex Hormones | INTRAARTICULAR HYALURONIC ACID Injection Hand joint | Therapeutic immunosuppression biological | Immunosuppressive Agents Oral
Item
1. previous exposure to any anti-interleukin-1 treatment, to corticosteroids within 1 month prior to screening, to intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to screening, to any immunosuppressive biologic therapy within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug, or current use of immunosuppressive oral medications within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug.
boolean
C0332157 (UMLS CUI [1,1])
C2917260 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0493951 (UMLS CUI [3,1])
C1533685 (UMLS CUI [3,2])
C0459470 (UMLS CUI [3,3])
C0021079 (UMLS CUI [4,1])
C0205460 (UMLS CUI [4,2])
C0021081 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
Absolute neutrophil count
Item
2. absolute neutrophil count < 2,000 mm3
boolean
C0948762 (UMLS CUI [1])
Diagnosis Quantity
Item
3. diagnosis of one or more of the following:
boolean
C0011900 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Fibromyalgia
Item
fibromyalgia,
boolean
C0016053 (UMLS CUI [1])
Arthritis | Rheumatoid Arthritis | Spondylarthropathy Peripheral Seronegative
Item
inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy,
boolean
C0003864 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0949691 (UMLS CUI [3,1])
C0205100 (UMLS CUI [3,2])
C0521144 (UMLS CUI [3,3])
Arthritis, Psoriatic | Psoriasis
Item
psoriatic arthritis, psoriasis,
boolean
C0003872 (UMLS CUI [1])
C0033860 (UMLS CUI [2])
Crystal Arthropathy Affecting Hands | Gout | Pseudogout
Item
microcrystalline (including gout and pseudo gout) arthritis affecting the hands,
boolean
C0152087 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0018563 (UMLS CUI [1,3])
C0018099 (UMLS CUI [2])
C0033802 (UMLS CUI [3])
Osteoarthritis of the hand Due to Communicable Disease | Osteoarthritis of the hand Due to Episode Traumatic | Secondary osteoarthritis | Osteoarthritis Relationship Cartilage dysplasia | Osteoarthritis Relationship Bone dysplasia
Item
any oa of the hands due to an infectious origin or acute traumatic episode, secondary oa or oa linked to cartilage and bone dysplasia,
boolean
C0263746 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0263746 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0332189 (UMLS CUI [2,3])
C0332663 (UMLS CUI [2,4])
C2732281 (UMLS CUI [3])
C0029408 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0007301 (UMLS CUI [4,3])
C0334044 (UMLS CUI [4,4])
C0029408 (UMLS CUI [5,1])
C0439849 (UMLS CUI [5,2])
C0005941 (UMLS CUI [5,3])
Chronic pain syndrome Interferes with Assessment Hand pain
Item
other chronic painful syndromes that could interfere with assessment of pain at the hand(s).
boolean
C1298685 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0239833 (UMLS CUI [1,4])
Illness Uncontrolled | Therapy Unstable
Item
4. any uncontrolled medical illness or an unstable treatment or therapy.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Heart Disease
Item
5. clinically significant cardiac disease.
boolean
C0018799 (UMLS CUI [1])
Dysplasia | Malignant Neoplasms | Exception Squamous cell carcinoma of skin Treated | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Localized
Item
6. evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
boolean
C0334044 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C0392752 (UMLS CUI [5,3])
Chronic infectious disease Persistent Hospitalization Required | Communicable Disease Hospitalization Required | Microbicides | Antibiotics
Item
7. history of persistent chronic or active infection(s) requiring hospitalization or treatment with antimicrobials/antibiotics.
boolean
C0151317 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C1708385 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1708385 (UMLS CUI [2,2])
C1136254 (UMLS CUI [3])
C0003232 (UMLS CUI [4])
Reason Preventing MRI
Item
8. any reason that prohibits a subject to undergo an mri.
boolean
C0392360 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial