Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis Identifier: NCT03574545

Novartis Reference Number: CVAY736A2101

Last Update: Dec 03, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.

Rheumatoid Arthritis
Phase 1
Overall status 
Start date 
Dec 19, 2018
Completion date 
Nov 20, 2023
18 Years - 65 Years (Adult, Older Adult)


Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)

Eligibility Criteria

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 Locations

Novartis Investigative Site
Berlin, 10117


Novartis Pharmaceuticals

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