Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis Patients
1 other identifier
interventional
75
2 countries
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 rheumatoid-arthritis
Started Jan 2013
Longer than P75 for phase_1 rheumatoid-arthritis
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2013
CompletedFirst Submitted
Initial submission to the registry
March 13, 2014
CompletedFirst Posted
Study publicly available on registry
March 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2017
CompletedDecember 11, 2020
March 1, 2019
4.1 years
March 13, 2014
December 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with adverse events as a measure of safety and tolerability
7 months
Secondary Outcomes (5)
Plasma Pharmacokinetics (PK) of CFZ533: Area Under the Plasma Concentration-time Curve (AUC)
6 months
Plasma Pharmacokinetics (PK) of CFZ533: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)
6 months
Plasma Pharmacokinetics (PK) of CFZ533: Systemic Clearance from Plasma (CL)
6 months
Plasma Pharmacokinetics (PK) of CFZ533: Apparent Volume of Distribution (Vss)
6 months
CFZ533 immunogenicity
6 months
Study Arms (3)
CFZ533 in healthy volunteers
EXPERIMENTALCFZ533 single dose in healthy volunteers
CFZ533 in rheumatoid arthritis patients
EXPERIMENTALCFZ533 single dose in rheumatoid arthritis patients
Placebo
PLACEBO COMPARATORPlacebo single dose
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age (for Cohort 9 only, subjects must be of Chinese descent)
- Vital signs (systolic and diastolic blood pressure and pulse rate) should be within normal limits
- Weight 50-150 kg and a body mass index (BMI) 18-32 kg/m2
- Healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age
- Fulfilled 2010 ACR/EULAR classification criteria for RA per Investigator
- Treatment with a stable oral RA treatment regimen for ≥ 4 weeks before randomization
- Systemic corticosteroids allowed if on a stable dose (≤ 10 mg/day of prednisone or equivalent) ≥ 4 weeks prior to randomization
- Subjects taking NSAIDs (COX-1 or COX-2 inhibitors) as part of their RA therapy must be on a stable dose for at least 4 weeks before randomization
You may not qualify if:
- History of hypersensitivity to vaccines, the study drug, or to drugs of similar chemical classes (i.e., biologic agents)
- Abnormal hematology, coagulation or inflammatory lab results
- History or evidence of tuberculosis.
- Use of anti-TNF or other biologics in previous 3 months
- Any intra-articular injection therapy (e.g., corticosteroid, hyaluronan) required for treatment of acute RA flare within 4 weeks before randomization
- Previous treatment with a B cell-depleting biologic agent or any other immunomodulatory biologic agent within 5 half-lives (experimental or approved)
- Current treatment with cyclophosphamide
- Autoimmune disease other than RA
- Adult juvenile rheumatoid arthritis
- RA functional status class IV according to the ACR 1991 revised criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Novartis Investigative Site
Anniston, Alabama, 36207-5710, United States
Novartis Investigative Site
Miami, Florida, 33136, United States
Novartis Investigative Site
South Miami, Florida, 33143, United States
Novartis Investigative Site
Lincoln, Nebraska, 68502, United States
Novartis Investigative Site
Duncansville, Pennsylvania, 16635, United States
Novartis Investigative Site
Taipei, 110, Taiwan
Related Publications (1)
Espie P, He Y, Koo P, Sickert D, Dupuy C, Chokote E, Schuler R, Mergentaler H, Ristov J, Milojevic J, Verles A, Groenewegen A, Auger A, Avrameas A, Rotte M, Colin L, Tomek CS, Hernandez-Illas M, Rush JS, Gergely P. First-in-human clinical trial to assess pharmacokinetics, pharmacodynamics, safety, and tolerability of iscalimab, an anti-CD40 monoclonal antibody. Am J Transplant. 2020 Feb;20(2):463-473. doi: 10.1111/ajt.15661. Epub 2019 Dec 6.
PMID: 31647605DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2014
First Posted
March 17, 2014
Study Start
January 7, 2013
Primary Completion
February 3, 2017
Study Completion
February 3, 2017
Last Updated
December 11, 2020
Record last verified: 2019-03