Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of VAY736 in Rheumatoid Arthritis Patients

Novartis

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Biological: VAY736; Biological: VAY736 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02675803

CVAY736X2101

2010-020156-65

Details and patient eligibility

About

This study investigated the safety and tolerability of VAY736 administered as single ascending doses of intravenous infusion, subcutaneous injection and repeated subcutaneous injections in rheumatoid arthritis patients.

Full description

This study had three sequential parts which investigated the safety and tolerability of VAY736 administered as single ascending doses of intravenous infusion (Part 1), single ascending doses of subcutaneous injection (Part 2), and repeated subcutaneous injections of fixed doses (Part 3), respectively, in rheumatoid arthritis patients. Part 1 was double blind, placebo controlled, with 11 cohorts. Part 2 was open-label study with 2 dosing cohorts. Part 3 was open-label study with 1 fixed-dose cohort.

Enrollment: 65 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active disease despite methotrexate treatment 5 to 20 mg/week for Parts 1 and 2; methotrexate treatment 5 to 20 mg/week for Part 3
• Fulfilled 2010 American College of Rheumatolody (ACR)/European League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis for Part 1 and Part 2. For Part 3, fulfilled 2010 American College of Rheumatolody (ACR)/)/European League Against Rheumatism (EULAR) classification criteria or/and 1987 American College of Rheumatolody (ACR) classification criteria for rheumatoid arthritis;
• Methotrexate ≥ 16 weeks, stable dose ≥ 8 weeks

Exclusion criteria

• Previous treatment with a B cell-depleting biologic agent.
• Autoimmune disease other than RA except concurrent Sjogren's syndrome
• Adult juvenile rheumatoid arthritis
• ARA functional class IV disease of ACR Revised Steinbrocker Classification

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups, including a placebo group

VAY736

Experimental group

Description:

VAY736 active

Treatment:

Biological: VAY736

Placebo

Placebo Comparator group

Description:

VAY736 placebo

Treatment:

Biological: VAY736 placebo