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

ClinicalTrials.gov Identifier: NCT03574545

Novartis Reference Number: CVAY736A2101

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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.

Condition 
Rheumatoid Arthritis
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
50 participants
Start date 
Dec 19, 2018
Completion date 
Feb 10, 2023
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

Biological
ianalumab
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

Germany
Novartis Investigative Site
Recruiting
Berlin, 10117
-
Germany
Jordan
Novartis Investigative Site
Recruiting
Amman, 11941
-
Jordan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]