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

NCT ID: NCT02675803

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-20

Study Completion Date

2018-01-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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VAY736

VAY736 active

Group Type EXPERIMENTAL

VAY736

Intervention Type BIOLOGICAL

VAY736 treatment

Placebo

VAY736 placebo

Group Type PLACEBO_COMPARATOR

VAY736 placebo

Intervention Type BIOLOGICAL

VAY736 placebo

Interventions

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VAY736

VAY736 treatment

Intervention Type BIOLOGICAL

VAY736 placebo

VAY736 placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Berlin, , Germany

Site Status

Countries

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Germany

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17297

Results for CVAY736X2101 from the Novartis Clinical Trials Website

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=422

A Plain Language Trial Summary is available on novartisclinicatrials.com

Other Identifiers

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2010-020156-65

Identifier Type: -

Identifier Source: secondary_id

CVAY736X2101

Identifier Type: -

Identifier Source: org_study_id