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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005998-27-DK

Enrollment

Registered

2021-01-25

Start date

2021-03-12

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis MedDRA version: 23.1 Level: LLT Classification code 10060732 Term: Rheumatoid arthritis flare up System Organ Class: 100000004859

Interventions

Trade Name: RoActemra Product Name: RoActemra Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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. 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. 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.	—

Measure

Time frame

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. 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. 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.

—

Countries

Denmark

Contacts

Public ContactDepartment of Public Health

University of Southern Denmark

acdunvald@health.sdu.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026