- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03923738
Recruitment Status Completed
First Posted April 23, 2019
Last update posted December 10, 2020
This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).
Participants will receive up to 6 doses of Dose 1 of TCZ IV Q4W followed by up to 6 doses of Dose 2 of TCZ IV Q4W.
TCZ will be administered by IV infusion at two dose levels Q4W. The maximum dose of TCZ that will be administered is 800 mg. The dose of TCZ infusion will be calculated on the basis of body weight measured prior to each infusion.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Diagnosis of GCA as classified according to protocol-specified criteria;
- Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.
- Treatment with any other investigational agent besides TCZ within 12 weeks (or 5
half-lives of the investigational drug, whichever is longer) prior to screening;
- Evidence of serious uncontrolled disease;
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial,
or other infections;
- Active TB requiring treatment within the previous 3 years.
Universitätsspital Basel; Rheumatologie
Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie
Study Director: Clinical Trials Hoffmann-La Roche