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Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis

Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis

NCT01565408•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid arthritis (RA).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•A diagnosis of RA, meeting the 2010 ACR-EULAR (American College of Rheumatology-European League Against Rheumatism) or the 1987 ACR classification criteria, made at least 4 months prior to trial drug administration
•Active RA, characterised by a DAS28-CRP equal to or above 4.5 and at least 5 tender and 5 swollen joints
•Methotrexate (MTX) treatment for at least 16 weeks (dose equal to or above 7.5 mg/week and equal to or below 25 mg/week) at a stable dose for at least 6 weeks prior to dosing
•Female subjects not pregnant and not nursing

Exclusion Criteria

•Subjects with chronic inflammatory autoimmune disease other than RA
•Any active or ongoing chronic infectious disease requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
•Body mass index (BMI) below 18.0 or above 35.0 kg/m\^2

Locations (5)

Novo Nordisk Investigational Site

Berlin, Germany

Novo Nordisk Investigational Site

Moscow, Russia

Novo Nordisk Investigational Site

Moscow, Russia

Novo Nordisk Investigational Site

Moscow, Russia

Novo Nordisk Investigational Site

Yaroslavl, Russia

Key Dates

Start Date

March 1, 2012

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

February 8, 2017

Enrollment

32

ACTUAL participants

Conditions

InflammationRheumatoid Arthritis

Interventions

NNC0114-0006

DRUG

placebo

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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