ID

19212

Beschreibung

Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept; ODM derived from: https://clinicaltrials.gov/show/NCT00317538

Link

https://clinicaltrials.gov/show/NCT00317538

Stichworte

Versionen (1)
  1. 12.12.16 12.12.16 -
Hochgeladen am

12. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00317538

Englisch

Eligibility Rheumatoid Arthritis NCT00317538

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients have a diagnosis of ra according to the revised 1987 criteria of the american rheumatism association
Beschreibung

Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
have been receiving background mtx for at least 2 months prior to week -4
Beschreibung

Methotrexate

Datentyp

boolean

Alias
UMLS CUI [1]
C0025677
have been receiving a stable etanercept dose of 25 mg subcutaneously twice weekly for at least 2 months prior to week -4
Beschreibung

Etanercept Subcutaneous Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0717758
UMLS CUI [1,2]
C1522438
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
must have been using oral or parenteral mtx for the 2 months prior to screening and at a stable dose of 7.5 to 25 mg per week between week -4 and week 0
Beschreibung

Methotrexate Oral Product Dose Stable | Methotrexate Injectable Product Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3216566
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C3216565
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
have shown improvement in signs and symptoms of ra in response to etanercept and mtx according to both the patient and the treating physician
Beschreibung

Rheumatoid Arthritis Signs and Symptoms Improvement | Etanercept Disease Response | Methotrexate Disease Response

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0037088
UMLS CUI [1,3]
C2986411
UMLS CUI [2,1]
C0717758
UMLS CUI [2,2]
C1704632
UMLS CUI [3,1]
C0025677
UMLS CUI [3,2]
C1704632
have active disease as defined by both a tjc of at least 9 (on the 68 joint set) and sjc of at least 6 (on the 66 joint set)
Beschreibung

Rheumatoid Arthritis | Tender joint count | Swollen joint count

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0451530
UMLS CUI [3]
C0451521
have a documented negative reaction to a purified protein derivative (ppd) skin test (ppd induration< 5 mm) performed within 3 months prior to the week 0 visit
Beschreibung

PPD skin test negative | PPD induration

Datentyp

boolean

Alias
UMLS CUI [1]
C1328483
UMLS CUI [2]
C2059397
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients have been receiving corticosteroids (ie, via any route) at doses > 10 mg prednisone equivalent daily or have not been taking a stable dose of corticosteroids for at least 1 month prior to week -4
Beschreibung

Adrenal Cortex Hormones Drug Administration Routes Any | Adrenal Cortex Hormones Dose Prednisone Equivalent | Adrenal Cortex Hormones Dose Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0032952
UMLS CUI [2,4]
C0205163
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0443343
have started receiving nonsteroidal anti-inflammatory drugs (nsaids) within 1 month of week -4 or have not been on a stable dose of nsaids for at least 1 month prior to week -4
Beschreibung

Non-Steroidal Anti-Inflammatory Agents Started | Non-Steroidal Anti-Inflammatory Agents Dose Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1272689
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0443343
have received disease modifying anti-rheumatic drugs (dmards) or immunosuppressives (except mtx) for at least 1 month prior to week 0
Beschreibung

Antirheumatic Drugs, Disease-Modifying | Immunosuppressive Agents | Methotrexate

Datentyp

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2]
C0021081
UMLS CUI [3]
C0025677
patients who have received any prior treatment with infliximab or with any other therapeutic agent targeted at reducing tnf, except etanercept, (e.g.pentoxifylline or thalidomide)
Beschreibung

infliximab | Tumor necrosis factor alpha (TNF-) inhibitors | Etanercept | Pentoxifylline | Thalidomide

Datentyp

boolean

Alias
UMLS CUI [1]
C0666743
UMLS CUI [2]
C3653350
UMLS CUI [3]
C0717758
UMLS CUI [4]
C0030899
UMLS CUI [5]
C0039736
patients with a concomitant diagnosis of congestive heart failure, including medically controlled asymptomatic patients
Beschreibung

Congestive heart failure | Patients Asymptomatic Disease Controlled

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0231221
UMLS CUI [2,3]
C2911690
any current known malignancy or history of malignancy within the previous 5 years
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
serious infection within the past 3 months or history of chronic infection such as hepatitis, pneumonia, or pyelonephritis in the previous 3 months, any opportunistic infections
Beschreibung

Communicable Diseases Serious | Chronic infectious disease | Hepatitis | Pneumonia | Pyelonephritis | Opportunistic Infections

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0032285
UMLS CUI [5]
C0034186
UMLS CUI [6]
C0029118
known substance abuse (drug or alcohol) within the previous 3 years
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
Beschreibung

Pregnancy | Breast Feeding | Gender Planned Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0032992
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00317538

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
patients have a diagnosis of ra according to the revised 1987 criteria of the american rheumatism association
boolean
C0003873 (UMLS CUI [1])
Methotrexate
Item
have been receiving background mtx for at least 2 months prior to week -4
boolean
C0025677 (UMLS CUI [1])
Etanercept Subcutaneous Dose Stable
Item
have been receiving a stable etanercept dose of 25 mg subcutaneously twice weekly for at least 2 months prior to week -4
boolean
C0717758 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Methotrexate Oral Product Dose Stable | Methotrexate Injectable Product Dose Stable
Item
must have been using oral or parenteral mtx for the 2 months prior to screening and at a stable dose of 7.5 to 25 mg per week between week -4 and week 0
boolean
C3216566 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C3216565 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Rheumatoid Arthritis Signs and Symptoms Improvement | Etanercept Disease Response | Methotrexate Disease Response
Item
have shown improvement in signs and symptoms of ra in response to etanercept and mtx according to both the patient and the treating physician
boolean
C0003873 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C2986411 (UMLS CUI [1,3])
C0717758 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C0025677 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
Rheumatoid Arthritis | Tender joint count | Swollen joint count
Item
have active disease as defined by both a tjc of at least 9 (on the 68 joint set) and sjc of at least 6 (on the 66 joint set)
boolean
C0003873 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
PPD skin test negative | PPD induration
Item
have a documented negative reaction to a purified protein derivative (ppd) skin test (ppd induration< 5 mm) performed within 3 months prior to the week 0 visit
boolean
C1328483 (UMLS CUI [1])
C2059397 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Adrenal Cortex Hormones Drug Administration Routes Any | Adrenal Cortex Hormones Dose Prednisone Equivalent | Adrenal Cortex Hormones Dose Unstable
Item
patients have been receiving corticosteroids (ie, via any route) at doses > 10 mg prednisone equivalent daily or have not been taking a stable dose of corticosteroids for at least 1 month prior to week -4
boolean
C0001617 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0032952 (UMLS CUI [2,3])
C0205163 (UMLS CUI [2,4])
C0001617 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0443343 (UMLS CUI [3,3])
Non-Steroidal Anti-Inflammatory Agents Started | Non-Steroidal Anti-Inflammatory Agents Dose Unstable
Item
have started receiving nonsteroidal anti-inflammatory drugs (nsaids) within 1 month of week -4 or have not been on a stable dose of nsaids for at least 1 month prior to week -4
boolean
C0003211 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Antirheumatic Drugs, Disease-Modifying | Immunosuppressive Agents | Methotrexate
Item
have received disease modifying anti-rheumatic drugs (dmards) or immunosuppressives (except mtx) for at least 1 month prior to week 0
boolean
C0242708 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
infliximab | Tumor necrosis factor alpha (TNF-) inhibitors | Etanercept | Pentoxifylline | Thalidomide
Item
patients who have received any prior treatment with infliximab or with any other therapeutic agent targeted at reducing tnf, except etanercept, (e.g.pentoxifylline or thalidomide)
boolean
C0666743 (UMLS CUI [1])
C3653350 (UMLS CUI [2])
C0717758 (UMLS CUI [3])
C0030899 (UMLS CUI [4])
C0039736 (UMLS CUI [5])
Congestive heart failure | Patients Asymptomatic Disease Controlled
Item
patients with a concomitant diagnosis of congestive heart failure, including medically controlled asymptomatic patients
boolean
C0018802 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C2911690 (UMLS CUI [2,3])
Malignant Neoplasms
Item
any current known malignancy or history of malignancy within the previous 5 years
boolean
C0006826 (UMLS CUI [1])
Communicable Diseases Serious | Chronic infectious disease | Hepatitis | Pneumonia | Pyelonephritis | Opportunistic Infections
Item
serious infection within the past 3 months or history of chronic infection such as hepatitis, pneumonia, or pyelonephritis in the previous 3 months, any opportunistic infections
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0151317 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0032285 (UMLS CUI [4])
C0034186 (UMLS CUI [5])
C0029118 (UMLS CUI [6])
Substance Use Disorders
Item
known substance abuse (drug or alcohol) within the previous 3 years
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Gender Planned Pregnancy
Item
are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
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