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

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.

Inclusion criteria

(for healthy volunteers):

• 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

Inclusion criteria

(for rheumatoid arthritis patients):

• 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

Exclusion criteria

(for healthy volunteers):

• 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.

Exclusion criteria

(for rheumatoid arthritis patients):

• 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

Other protocol-defined inclusion/exclusion criteria may apply