Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

Novo Nordisk

Status and phase

Completed

Phase 2

Conditions

Inflammation

Rheumatoid Arthritis

Treatments

Drug: NNC109-0012

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01282255

2010-021283-14 (EudraCT Number)

NN8226-3875

U1111-1117-1136 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

67 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)