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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03781310 |
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Date of registration:
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17/12/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Therapeutic Drug Monitoring of Tocilizumab in Rheumatoid Arthritis
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Scientific title:
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Therapeutic Drug Monitoring of Tocilizumab in Rheumatoid Arthritis |
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Date of first enrolment:
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December 2018 |
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Target sample size:
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80 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03781310 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Israel
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Contacts
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Name:
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Uri Arad |
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Address:
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Telephone:
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+972524262446 |
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Email:
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uria@tlvmc.gov.il |
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Affiliation:
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Name:
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Uri Arad |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tel-Aviv Sourasky Medical Center |
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Name:
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Ori Elkayam, M.D |
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Address:
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Telephone:
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97236973668 |
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Email:
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orie@tasmc.health.gov.il |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- RA according to the ACR 1987 or 2010 criteria;
- Current use of tocilizumab IV, with a consistent interval of 4 weeks for at least 24
weeks.
- 18 years of age and older.
Exclusion Criteria:
- A potential subject will be excluded from participation in case of a scheduled surgery
in the next 20 weeks or other preplanned reasons for treatment discontinuation.
- Children, pregnant women and individuals with a lack of judgement.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tocilizumab
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Tocilizumab
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Primary Outcome(s)
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Drop-out rate
[Time Frame: 20 weeks]
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Disease flare rate
[Time Frame: 20 weeks]
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Secondary Outcome(s)
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DAS28 score
[Time Frame: 20 weeks]
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RAPID-3
[Time Frame: 20 weeks]
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SDAI score
[Time Frame: 20 weeks]
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patient disease activity VAS
[Time Frame: 20 weeks]
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sHAQ
[Time Frame: 20 weeks]
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physician global VAS
[Time Frame: 20 weeks]
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Swollen joint count
[Time Frame: 20 weeks]
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Tender joint count
[Time Frame: 20 weeks]
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CDAI score
[Time Frame: 20 weeks]
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patient pain VAS
[Time Frame: 20 weeks]
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Secondary ID(s)
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0563-18-TLV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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