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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Mar 2012

Geographic Reach

2 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

March 1, 2012

Completed

20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed

7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed

Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

March 21, 2012

Last Update Submit

February 6, 2017

Conditions

Inflammation Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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)

Study Arms (2)

NNC0114-0006

EXPERIMENTAL

Drug: NNC0114-0006

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

NNC0114-0006DRUG

Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks. The trial comprises dose escalation up to four dose levels. Progression to next dose will be based on safety evaluation.

NNC0114-0006

placeboDRUG

Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks.

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.