Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active 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_2

Timeline

Completed

Started Feb 2011

Shorter than P25 for phase_2

Geographic Reach

8 countries

29 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

11 months study duration

First Submitted

Initial submission to the registry

January 21, 2011

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2011

Completed

8 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed

Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

January 21, 2011

Last Update Submit

February 8, 2017

Conditions

Inflammation Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)
week 0, week 12

Secondary Outcomes (2)

Terminal serum half-life (t½)
end of treatment period
Serum levels of NNC109-0012
end of treatment period

Study Arms (2)

A

EXPERIMENTAL

Drug: NNC109-0012

B

PLACEBO COMPARATOR

Drug: placebo

Interventions

NNC109-0012DRUG

The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)

placeboDRUG

The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Czech Republic: Age between 18 - 65 years (both inclusive)
A diagnosis of RA made at least 3 months prior to trial start
Active RA
Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start
Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication
Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode

You may not qualify if:

Known or suspected allergy to trial product or related products
Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m\^2
Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)

Contact the study team to confirm eligibility.