Status:
TERMINATED
Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis
Lead Sponsor:
University of Southern Denmark
Collaborating Sponsors:
Odense University Hospital
Esbjerg Hospital - University Hospital of Southern Denmark
Conditions:
Arthritis, Rheumatoid
Interaction
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
With this study the investigators aim to assess if drug metabolism changes in patients with rheumatoid arthritis when an interleukin (IL)-6 inhibitor is initiated. Patients with rheumatoid arthritis ...
Eligibility Criteria
Inclusion
- Active rheumatoid arthritis
- Age 18-75 years
- eGFR \> 30 mL/min
- absolute neutrophil count (ANC) ≥ 2 x 109 /L
- Platelet count \> 150 x 103 /μL (corresponding to \>150 x 109 /L)
- ALAT in the normal range or within 1.5x the upper limit of normal.
- Use of effective contraception (only woman of childbearing potential)
- Negative test for hepatitis and tuberculosis
Exclusion
- Known sensitivity to any of the medications used.
- Active severe infections
- Malignancy
- Diverticulitis
- Intake of medications which can influence the safety of the patient or the results of the study. Can include prescription medications, over-the-counter medications, herbal medicines or dietary supplements. Will be assessed by the investigators.
- Participation in other clinical intervention trials.
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04842981
Start Date
May 25 2021
End Date
September 30 2022
Last Update
January 25 2023
Active Locations (3)
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1
Hospital South West Jutland
Esbjerg, Region Syddanmark, Denmark, 6700
2
Odense University Hospital
Odense, Region Syddanmark, Denmark, 5000
3
Danish Hospital for Rheumatic Diseases
Sønderborg, Region Syddanmark, Denmark, 6400