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

Phase 1

Completed

• Conditions: Inflammation; Rheumatoid Arthritis
• Interventions: Drug: placebo; Drug: NNC0114-0006

• Registration Number: NCT01565408
• Lead Sponsor: Novo Nordisk A/S

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
NNC0114-0006	NNC0114-0006	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	From first administration of trial product (week 1) and up until week 27

Secondary Outcome Measures

Name	Time	Method
Change in serum levels of total IL-21 from first administration of trial product	Week 1, week 27
Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP)	From week 1 to week 9 (8 weeks after initiation of treatment)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇷🇺 Yaroslavl, Russian Federation