Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, RA, first-in-human, single ascending dose, safety, tolerability
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.
Detailed description
This was a Healthy Volunteer only study originally, but after an amendment to protocol, rheumatoid arthritis patients will be starting 7-Mar-2014 and thus, the protocol is now registered.
Interventions
BIOLOGICALCFZ533
Single dose at varying dosage levels depending on treatment assignment
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
(for healthy volunteers): 1. 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) 2. Vital signs (systolic and diastolic blood pressure and pulse rate) should be within normal limits 3. Weight 50-150 kg and a body mass index (BMI) 18-32 kg/m2 Inclusion Criteria (for rheumatoid arthritis patients): 1. Healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age 2. Fulfilled 2010 ACR/EULAR classification criteria for RA per Investigator 3. Treatment with a stable oral RA treatment regimen for ≥ 4 weeks before randomization 4. Systemic corticosteroids allowed if on a stable dose (≤ 10 mg/day of prednisone or equivalent) ≥ 4 weeks prior to randomization 5. 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
Exclusion criteria
(for healthy volunteers): 1. History of hypersensitivity to vaccines, the study drug, or to drugs of similar chemical classes (i.e., biologic agents) 2. Abnormal hematology, coagulation or inflammatory lab results 3. History or evidence of tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events as a measure of safety and tolerability | 7 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Pharmacokinetics (PK) of CFZ533: Area Under the Plasma Concentration-time Curve (AUC) | 6 months | The following PK parameters were determined from the plasma concentration time profile of CFZ533 using a non-compartmental method: AUCtau: Area under the plasma concentration-time curve from time zero to the end of the dosing interval AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration AUCinf: Area under the plasma concentration-time curve from time zero to infinity |
| 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 | Determining the presence and measuring amount of anti-CFZ533 antibodies in the blood |
Countries
Taiwan, United States
Outcome results
None listed