Interleukin-6 inhibitors and drug-drug interactions in patients with Rheumatoid Arthritis.

Phase 1

• Conditions: Rheumatoid arthritis; MedDRA version: 23.1Level: LLTClassification code 10060732Term: Rheumatoid arthritis flare upSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-005998-27-DK
• Lead Sponsor: niversity of Southern Denmark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-25
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to investigate if drug metabolism changes in patients with rheumatoid arthritis when they initiate treatment with an IL-6 inhibitor.;Secondary Objective: Change in inflammation following initiation of IL-6 inhibitor treatment. ;Primary end point(s): A change in metabolic ratio of midazolam after 3 weeks of treatment with an IL-6Ra as compared to baseline. The metabolic ratio of midazolam is used to assess the activity of CYP3A4. ;Timepoint(s) of evaluation of this end point: After the study is completed and drug analysis is completed.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): A change in metabolic ratio of midazolam after 12 weeks of treatment with an IL-6R as compared to baseline. The metabolic ratio of midazolam is used to assess the activity of CYP3A4.<br><br>A change in the metabolic ratio of caffeine, efavirenz, losartan, omeprazole and metoprolol after 3 and 12 weeks, as markers of activity of CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP2D6, respectively. <br><br>Change in inflammation measured by a panel of inflammatory markers. ;Timepoint(s) of evaluation of this end point: After the study is completed and analyses are completed.