Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Recruitment & Eligibility

Inclusion Criteria

Fulfill 2010 ACR/EULAR criteria for RA Aletaha et al 2010 at Screening
Active disease defined as ≥ 2 swollen joints (of 58 evaluable joints) and ≥ 2 tender joints (of 60 evaluable joints) despite stable MTX ≤ 25 mg/week and/or hydroxychloroquine ≤ 400 mg/day treatment for at least 2 months prior to randomization

Exclusion Criteria

Prior or previous use of (specific dosages and intervals prior to study start may apply): other investigational drugs, B-cell depleting therapy (e.g. rituximab), monoclonal antibodies (mAb), i.v. / s.c. Ig, thymoglobulin, i.v. or oral cyclophosphamide, oral cyclosporine, soluble cytokine receptors, azathioprine.
Currently receiving prednisone >10 mg/day (or equivalent oral glucocorticoid) or dose adjustment within 2 weeks prior to randomization
Active viral, bacterial or other infections requiring systemic treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
Receipt of live/attenuated vaccine within a 2-month period before randomization
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception from screening and for 4 months after stopping of investigational drug

Study & Design

Arm && Interventions

Group	Intervention	Description
Reference VAY736 Drug Product	ianalumab	Powder for solution for injection / infusion
Test VAY736 Drug Product	ianalumab	Solution for injection

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic comparability at steady state - AUCtau	Week 8 - 12	The area under the serum ianalumab concentration-time curve from time zero to the end of the dosing interval (AUCtau)
Safety and tolerability as measured by the number of patients with adverse events	Week 0 - 112	The number of patients with adverse events after repeated subcutaneous (s.c) injections of a fixed dose of ianalumab
Pharmacokinetic comparability at steady state - Cmax	Week 8 - 12	Observed maximum serum concentration of ianalumab following drug administration (Cmax)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic comparability after the first dose - Cmax	Week 0 - 4	Observed maximum serum concentration of ianalumab following drug administration (Cmax)
Pharmacokinetic comparability after the first dose - Tmax	Week 0 - 4	Time to reach the maximum concentration after drug administration (Tmax)
Pharmacokinetic comparability of two ianalumab drug products after the last dose - AUCinf	Week 8 - 12	The area under the serum ianalumab concentration-time curve from time zero to infinity (AUCinf)
Pharmacokinetic comparability after the last dose - T1/2	Week 8 - 12	The terminal elimination half-life (T1/2)
Pharmacokinetic comparability at the end of each dosing interval - Ctrough	Week 0 - 12	Observed minimum serum ianalumab concentration following drug administration (Ctrough)
Pharmacokinetic comparability after the last dose - Tmax	Week 8 - 12	Time to reach the maximum concentration after drug administration (Tmax)
Pharmacodynamic effect as measured by B-cell level	Week 0 - 112	Circulating B cells (CD19+)
Immunogenicity as measured by Anti-Drug Antibodies	Week 0 - 112	Anti-ianalumab antibodies (ADA); incidence of ADA positive patients and correlation with AEs, PK and clinical outcomes
Pharmacokinetic comparability after the first dose - AUCtau	Week 0 - 4	The area under the serum ianalumab concentration-time curve from time zero to the end of the dosing interval (AUCtau)

Recruitment & Eligibility