drugset / Trial / NCT01220518
Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active Ankylosing Spondylitis patients.
Timeline
- Start
- 2010-10
- Primary completion
- 2011-11
- Completion
- 2012-06
Publications
- Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021 Feb;61(2):224-233. doi: 10.1002/jcph.1732. Epub 2020 Sep 9.
- Park W, Yoo DH, Jaworski J, Brzezicki J, Gnylorybov A, Kadinov V, Sariego IG, Abud-Mendoza C, Escalante WJ, Kang SW, Andersone D, Blanco F, Hong SS, Lee SH, Braun J. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther. 2016 Jan 20;18:25. doi: 10.1186/s13075-016-0930-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Infliximab | Monoclonal antibody | 5 mg/kg | — |