ID

19124

Description

New Immunomodulatory Therapy Strategies in Chronic Reactive Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00244179

Link

https://clinicaltrials.gov/show/NCT00244179

Keywords

Versions (1)
  1. 12/6/16 12/6/16 -
Uploaded on

December 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Reactive Arthritis NCT00244179

English

Eligibility Reactive Arthritis NCT00244179

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. definite classification of the arthritis as rea enteric rea is defined as an arthritis, which occurs within 4 weeks after a preceding symptomatic infection of the gut with enteric bacteria such as yersinia, salmonella, campylobacter jejuni, shigella. if no symptomatic preceding infection can be remembered the triggering enterobacterium has to be clearly identified by serology or stool culture. other causes for a diarrhea like for example inflammatory bowel disease have to be eliminated.
Description

Arthritis, Reactive | Enteric reactive arthritis | Gut Communicable Disease Symptomatic | Enterobacteriaceae | Yersinia | Salmonella | Campylobacter jejuni | Shigella | Serologic tests | Stool culture | Diarrhea | Inflammatory Bowel Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0085435
UMLS CUI [2]
C1458152
UMLS CUI [3,1]
C0699819
UMLS CUI [3,2]
C0009450
UMLS CUI [3,3]
C0231220
UMLS CUI [4]
C0014346
UMLS CUI [5]
C0043405
UMLS CUI [6]
C0036111
UMLS CUI [7]
C0006819
UMLS CUI [8]
C0036953
UMLS CUI [9]
C0036743
UMLS CUI [10]
C0430414
UMLS CUI [11]
C0011991
UMLS CUI [12]
C0021390
urogenital (chlamydia-triggered) rea is defined as an arthritis, which occurs within 4 weeks after a symptomatic urogenital infection or an infection of the upper airways or if chlamydia can be clearly identified be serology or direct proof.
Description

Urogenital Reactive Arthritis caused by Chlamydia | Urogenital infection Symptomatic | Upper Respiratory Infections | Serologic tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0085435
UMLS CUI [1,2]
C0042066
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0008148
UMLS CUI [2,1]
C0729523
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0041912
UMLS CUI [4]
C0036743
2. disease duration > 12 months
Description

disease length

Data type

boolean

Alias
UMLS CUI [1]
C0872146
3. age 18 to 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. active arthritis in at least one joint
Description

Arthritis Joints Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1265611
5. constant demand of nsaids
Description

Non-Steroidal Anti-Inflammatory Agents Constant Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1948059
UMLS CUI [1,3]
C0686904
6. intensity of pain > 4 on a visual analogue scale (vas; 0 to 10)
Description

Pain intensity Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0042815
7. patients are allowed to have been treated with so-called conventional therapy (sulphasalazine, methotrexate etc.) or steroids i.a. before, but they have to be stopped 4 weeks before enrolled into the trial
Description

Conventional Treatment | Sulfasalazine | Methotrexate | Steroids Intra-articular

Data type

boolean

Alias
UMLS CUI [1]
C2945704
UMLS CUI [2]
C0036078
UMLS CUI [3]
C0025677
UMLS CUI [4,1]
C0038317
UMLS CUI [4,2]
C0442108
8. able to self-administer s.c. injections or have a caregiver who will do so
Description

Subcutaneous Injections Self Administration Able | Caregiver Subcutaneous Injections Able

Data type

boolean

Alias
UMLS CUI [1,1]
C0021499
UMLS CUI [1,2]
C0036589
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0085537
UMLS CUI [2,2]
C0021499
UMLS CUI [2,3]
C0085732
9. women of child bearing potential must have a negative pregnancy test at study baseline and use an adequate, effective method of contraception (such as implants, injectables, combined oral contraceptives, some iuds, sexual abstinence, vasectomised partner) for a duration of 6 months after stop of therapy. sexual active men must use an accepted method of contraception for a duration of 6 months after stop of therapy.
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Contraceptive implant | Contraceptive injection | Combined Oral Contraceptives | Intrauterine Devices | Sexual Abstinence | Vasectomy Partner | Gender Sexually active Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C1657106
UMLS CUI [4]
C1656586
UMLS CUI [5]
C0009906
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0042387
UMLS CUI [8,2]
C0682323
UMLS CUI [9,1]
C0079399
UMLS CUI [9,2]
C0241028
UMLS CUI [9,3]
C0700589
10. reading a normal chest/ lung x-ray, negative mendel-mantoux-skin test (10,0 te) (both not older than 4 weeks). if mendel-mantoux-skin test is positive and / or there are hints for a healed up tuberculosis in the chest x-ray (latent tuberculosis) and the patient shall receive infliximab or etanercept an additional therapy with isoniazid 300 mg daily starting 4 weeks before first administration of infliximab or etanercept has to be given.
Description

Plain chest X-ray | Lung X-ray | Mantoux test Negative | Mantoux: positive | Tuberculosis Healed | Latent Tuberculosis | infliximab | Etanercept | isoniazid U/day

Data type

boolean

Alias
UMLS CUI [1]
C0039985
UMLS CUI [2]
C0581647
UMLS CUI [3,1]
C1304836
UMLS CUI [3,2]
C1513916
UMLS CUI [4]
C0032739
UMLS CUI [5,1]
C0041296
UMLS CUI [5,2]
C0205249
UMLS CUI [6]
C1609538
UMLS CUI [7]
C0666743
UMLS CUI [8]
C0717758
UMLS CUI [9,1]
C0022209
UMLS CUI [9,2]
C0456683
11. signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. female subjects who are pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. previous treatment with cytokines or anti-cytokines (biological agents)
Description

cytokine | anticytokines | Biological Factors

Data type

boolean

Alias
UMLS CUI [1]
C0079189
UMLS CUI [2]
C2236020
UMLS CUI [3]
C0005515
3. severe infections within the last 3 months
Description

Communicable Diseases Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
4. history of opportunistic infections within the last 2 months (herpes zoster, cytomegaly virus-, pneumocystis carinii-infection)
Description

Opportunistic Infections | Herpes zoster disease | Cytomegalovirus Infections | Pneumocystis Infections

Data type

boolean

Alias
UMLS CUI [1]
C0029118
UMLS CUI [2]
C0019360
UMLS CUI [3]
C0010823
UMLS CUI [4]
C0851886
5. hiv-infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
6. history of malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
7. receipt of any live (attenuated) vaccines within last 30 days before screening visit
Description

Vaccines, Attenuated

Data type

boolean

Alias
UMLS CUI [1]
C0042211
8. previous diagnosis or signs of demyelinating diseases
Description

Demyelinating Diseases | Demyelinating Diseases signs

Data type

boolean

Alias
UMLS CUI [1]
C0011303
UMLS CUI [2,1]
C0011303
UMLS CUI [2,2]
C0220912
9. history of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke, ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
Description

Diabetic - poor control | Myocardial Ischemia Unstable | Inflammatory Bowel Diseases | Peptic Ulcer | Cerebrovascular accident | Congestive heart failure | Condition At risk Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2,1]
C0151744
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0021390
UMLS CUI [4]
C0030920
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0018802
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C1444641
UMLS CUI [7,3]
C2348568
10. history of cytopenia
Description

cytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0010828
11. laboratory exclusions are: hemoglobin level < 8,5 g/dl, white blood cell count < 3.5 x109/l, platelet count < 125 x 109 /l, creatinine level > 175 µmol/ liver enzymes > 1,5, alkaline phosphatase >2 times the upper limit of normal, quick > 50.
Description

Laboratory Exclusion | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Creatinine measurement, serum | Measurement of liver enzyme | Alkaline phosphatase measurement | Quick method

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C2828389
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0428321
UMLS CUI [7]
C0201850
UMLS CUI [8]
C1441713
12. clinical examination showing significant abnormalities of clinical relevance
Description

Abnormality Significant Relevance Clinical | Physical Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C2347946
UMLS CUI [1,4]
C0205210
UMLS CUI [2]
C0031809
13. participation in trials of other investigational medications within 30 days of entering the study
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
14. history or current evidence of abuse of ”hard” drugs (e.g. cocaine/heroine)
Description

Hard drug abuse | Cocaine | Heroin

Data type

boolean

Alias
UMLS CUI [1,1]
C0301284
UMLS CUI [1,2]
C0013146
UMLS CUI [2]
C0009170
UMLS CUI [3]
C0011892
15. current medication with 7,5 mg or more prednisolon daily
Description

prednisolone U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0032950
UMLS CUI [1,2]
C0456683
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Similar models

Eligibility Reactive Arthritis NCT00244179

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Arthritis, Reactive | Enteric reactive arthritis | Gut Communicable Disease Symptomatic | Enterobacteriaceae | Yersinia | Salmonella | Campylobacter jejuni | Shigella | Serologic tests | Stool culture | Diarrhea | Inflammatory Bowel Diseases
Item
1. definite classification of the arthritis as rea enteric rea is defined as an arthritis, which occurs within 4 weeks after a preceding symptomatic infection of the gut with enteric bacteria such as yersinia, salmonella, campylobacter jejuni, shigella. if no symptomatic preceding infection can be remembered the triggering enterobacterium has to be clearly identified by serology or stool culture. other causes for a diarrhea like for example inflammatory bowel disease have to be eliminated.
boolean
C0085435 (UMLS CUI [1])
C1458152 (UMLS CUI [2])
C0699819 (UMLS CUI [3,1])
C0009450 (UMLS CUI [3,2])
C0231220 (UMLS CUI [3,3])
C0014346 (UMLS CUI [4])
C0043405 (UMLS CUI [5])
C0036111 (UMLS CUI [6])
C0006819 (UMLS CUI [7])
C0036953 (UMLS CUI [8])
C0036743 (UMLS CUI [9])
C0430414 (UMLS CUI [10])
C0011991 (UMLS CUI [11])
C0021390 (UMLS CUI [12])
Urogenital Reactive Arthritis caused by Chlamydia | Urogenital infection Symptomatic | Upper Respiratory Infections | Serologic tests
Item
urogenital (chlamydia-triggered) rea is defined as an arthritis, which occurs within 4 weeks after a symptomatic urogenital infection or an infection of the upper airways or if chlamydia can be clearly identified be serology or direct proof.
boolean
C0085435 (UMLS CUI [1,1])
C0042066 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0008148 (UMLS CUI [1,4])
C0729523 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0041912 (UMLS CUI [3])
C0036743 (UMLS CUI [4])
disease length
Item
2. disease duration > 12 months
boolean
C0872146 (UMLS CUI [1])
Age
Item
3. age 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
Arthritis Joints Quantity
Item
4. active arthritis in at least one joint
boolean
C0003864 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Non-Steroidal Anti-Inflammatory Agents Constant Patient need for
Item
5. constant demand of nsaids
boolean
C0003211 (UMLS CUI [1,1])
C1948059 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
Pain intensity Visual Analog Pain Scale
Item
6. intensity of pain > 4 on a visual analogue scale (vas; 0 to 10)
boolean
C1320357 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
Conventional Treatment | Sulfasalazine | Methotrexate | Steroids Intra-articular
Item
7. patients are allowed to have been treated with so-called conventional therapy (sulphasalazine, methotrexate etc.) or steroids i.a. before, but they have to be stopped 4 weeks before enrolled into the trial
boolean
C2945704 (UMLS CUI [1])
C0036078 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
C0038317 (UMLS CUI [4,1])
C0442108 (UMLS CUI [4,2])
Subcutaneous Injections Self Administration Able | Caregiver Subcutaneous Injections Able
Item
8. able to self-administer s.c. injections or have a caregiver who will do so
boolean
C0021499 (UMLS CUI [1,1])
C0036589 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0085537 (UMLS CUI [2,1])
C0021499 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Contraceptive implant | Contraceptive injection | Combined Oral Contraceptives | Intrauterine Devices | Sexual Abstinence | Vasectomy Partner | Gender Sexually active Contraceptive methods
Item
9. women of child bearing potential must have a negative pregnancy test at study baseline and use an adequate, effective method of contraception (such as implants, injectables, combined oral contraceptives, some iuds, sexual abstinence, vasectomised partner) for a duration of 6 months after stop of therapy. sexual active men must use an accepted method of contraception for a duration of 6 months after stop of therapy.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1657106 (UMLS CUI [3])
C1656586 (UMLS CUI [4])
C0009906 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0042387 (UMLS CUI [8,1])
C0682323 (UMLS CUI [8,2])
C0079399 (UMLS CUI [9,1])
C0241028 (UMLS CUI [9,2])
C0700589 (UMLS CUI [9,3])
Plain chest X-ray | Lung X-ray | Mantoux test Negative | Mantoux: positive | Tuberculosis Healed | Latent Tuberculosis | infliximab | Etanercept | isoniazid U/day
Item
10. reading a normal chest/ lung x-ray, negative mendel-mantoux-skin test (10,0 te) (both not older than 4 weeks). if mendel-mantoux-skin test is positive and / or there are hints for a healed up tuberculosis in the chest x-ray (latent tuberculosis) and the patient shall receive infliximab or etanercept an additional therapy with isoniazid 300 mg daily starting 4 weeks before first administration of infliximab or etanercept has to be given.
boolean
C0039985 (UMLS CUI [1])
C0581647 (UMLS CUI [2])
C1304836 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0032739 (UMLS CUI [4])
C0041296 (UMLS CUI [5,1])
C0205249 (UMLS CUI [5,2])
C1609538 (UMLS CUI [6])
C0666743 (UMLS CUI [7])
C0717758 (UMLS CUI [8])
C0022209 (UMLS CUI [9,1])
C0456683 (UMLS CUI [9,2])
Informed Consent
Item
11. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. female subjects who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
cytokine | anticytokines | Biological Factors
Item
2. previous treatment with cytokines or anti-cytokines (biological agents)
boolean
C0079189 (UMLS CUI [1])
C2236020 (UMLS CUI [2])
C0005515 (UMLS CUI [3])
Communicable Diseases Severe
Item
3. severe infections within the last 3 months
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Opportunistic Infections | Herpes zoster disease | Cytomegalovirus Infections | Pneumocystis Infections
Item
4. history of opportunistic infections within the last 2 months (herpes zoster, cytomegaly virus-, pneumocystis carinii-infection)
boolean
C0029118 (UMLS CUI [1])
C0019360 (UMLS CUI [2])
C0010823 (UMLS CUI [3])
C0851886 (UMLS CUI [4])
HIV Infection
Item
5. hiv-infection
boolean
C0019693 (UMLS CUI [1])
Malignant Neoplasms
Item
6. history of malignancy
boolean
C0006826 (UMLS CUI [1])
Vaccines, Attenuated
Item
7. receipt of any live (attenuated) vaccines within last 30 days before screening visit
boolean
C0042211 (UMLS CUI [1])
Demyelinating Diseases | Demyelinating Diseases signs
Item
8. previous diagnosis or signs of demyelinating diseases
boolean
C0011303 (UMLS CUI [1])
C0011303 (UMLS CUI [2,1])
C0220912 (UMLS CUI [2,2])
Diabetic - poor control | Myocardial Ischemia Unstable | Inflammatory Bowel Diseases | Peptic Ulcer | Cerebrovascular accident | Congestive heart failure | Condition At risk Study Subject Participation Status
Item
9. history of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke, ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
boolean
C0421258 (UMLS CUI [1])
C0151744 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0021390 (UMLS CUI [3])
C0030920 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0348080 (UMLS CUI [7,1])
C1444641 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
cytopenia
Item
10. history of cytopenia
boolean
C0010828 (UMLS CUI [1])
Laboratory Exclusion | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Creatinine measurement, serum | Measurement of liver enzyme | Alkaline phosphatase measurement | Quick method
Item
11. laboratory exclusions are: hemoglobin level < 8,5 g/dl, white blood cell count < 3.5 x109/l, platelet count < 125 x 109 /l, creatinine level > 175 µmol/ liver enzymes > 1,5, alkaline phosphatase >2 times the upper limit of normal, quick > 50.
boolean
C0022877 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0428321 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
C1441713 (UMLS CUI [8])
Abnormality Significant Relevance Clinical | Physical Examination
Item
12. clinical examination showing significant abnormalities of clinical relevance
boolean
C1704258 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
C0031809 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
13. participation in trials of other investigational medications within 30 days of entering the study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Hard drug abuse | Cocaine | Heroin
Item
14. history or current evidence of abuse of ”hard” drugs (e.g. cocaine/heroine)
boolean
C0301284 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
C0009170 (UMLS CUI [2])
C0011892 (UMLS CUI [3])
prednisolone U/day
Item
15. current medication with 7,5 mg or more prednisolon daily
boolean
C0032950 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
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