NCT02089087 is a Phase 1 clinical trial of CFZ533 in Rheumatoid Arthritis, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT02089087?

NCT02089087 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02089087?

Interventions in NCT02089087: CFZ533, Placebo.

What condition does NCT02089087 study?

NCT02089087 studies Rheumatoid Arthritis.

Is NCT02089087 still recruiting?

NCT02089087 is currently completed. Last updated 11 December 2020.

Last reviewed 2020-12-11 · How we verify

NCT02089087

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients

Completed Phase 1 Last updated 11 December 2020

What this trial tests

Phase 1 trial testing CFZ533 in Rheumatoid Arthritis in 75 participants. Completed in 3 February 2017.

Timeline

7 January 2013

Primary endpoint
3 February 2017

3 February 2017

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	75
Start date	7 January 2013
Primary completion	3 February 2017
Estimated completion	3 February 2017
Sites	6 locations across Taiwan, United States

Drugs / interventions tested

CFZ533 — full drug profile →
Placebo

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 55, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous and subcutaneous doses of CFZ533 in healthy subjects and intravenous doses in rheumatoid arthritis patients.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Recent advances in kidney transplantation: a viewpoint from the Descartes advisory board.
Abramowicz D, Oberbauer R, Heemann U, Viklicky O, et al · · 2018 · cited 40× · PMID 29342289 · DOI 10.1093/ndt/gfx365
Autoimmune manifestations in aged mice arise from early-life immune dysregulation.
Mahmoud TI, Wang J, Karnell JL, Wang Q, et al · · 2016 · cited 38× · PMID 27798262 · DOI 10.1126/scitranslmed.aag0367
Targeting the CD40-CD154 Signaling Pathway for Treatment of Autoimmune Arthritis.
Lai JH, Luo SF, Ho LJ. · · 2019 · cited 29× · PMID 31426619 · DOI 10.3390/cells8080927
Targeting TNF/TNFR superfamilies in immune-mediated inflammatory diseases.
Veerasubramanian PK, Wynn TA, Quan J, Karlsson FJ. · · 2024 · cited 26× · PMID 39297883 · DOI 10.1084/jem.20240806
New molecular targets in the treatment of rheumatoid arthritis.
Wallace BI, Cooney L, Fox DA. · · 2024 · cited 7× · PMID 38165286 · DOI 10.1097/bor.0000000000001000
FcγRs and Their Relevance for the Activity of Anti-CD40 Antibodies.
Lang I, Zaitseva O, Wajant H. · · 2022 · cited 6× · PMID 36361658 · DOI 10.3390/ijms232112869
Current Topics of Relevance to the Xenotransplantation of Free Pig Islets.
Mou L, Shi G, Cooper DKC, Lu Y, et al · · 2022 · cited 6× · PMID 35432379 · DOI 10.3389/fimmu.2022.854883

Verify or expand the search:

Other trials of CFZ533

Trials testing the same drug.

NCT04129528 — Study of Safety and Efficacy of CFZ533 in Type 1 Diabetes Pediatric and Young Adult Subjects · Phase 2 · completed
NCT03781414 — Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibo · Phase 2 · terminated
NCT03905525 — Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome · Phase 2 · completed
NCT03827798 — Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 2 · active not recruiting
NCT03656562 — Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients · Phase 2 · completed

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02089087 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 11 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02089087.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing