Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01282255

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Inflammation Rheumatoid Arthritis	Drug: NNC109-0012 Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: NNC109-0012 The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)
Placebo Comparator: B	Drug: placebo The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)

Arm

Intervention/Treatment

Experimental: A

Drug: NNC109-0012

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

Placebo Comparator: B

Drug: placebo

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Brno		Czech Republic	602 00
2	Novo Nordisk Investigational Site	Praha 2		Czech Republic	128 50
3	Novo Nordisk Investigational Site	Praha		Czech Republic	140 00
4	Novo Nordisk Investigational Site	Uherske Hradiste		Czech Republic	686 01
5	Novo Nordisk Investigational Site	Zlin		Czech Republic	760 01
6	Novo Nordisk Investigational Site	Berlin		Germany	14059
7	Novo Nordisk Investigational Site	Mainz		Germany	55131
8	Novo Nordisk Investigational Site	Würzburg		Germany	97080
9	Novo Nordisk Investigational Site	Pavia		Italy	27100
10	Novo Nordisk Investigational Site	Bialystok		Poland	15-296
11	Novo Nordisk Investigational Site	Bialystok		Poland	15-351
12	Novo Nordisk Investigational Site	Bydgoszcz		Poland	85-021
13	Novo Nordisk Investigational Site	Bytom		Poland	41-902
14	Novo Nordisk Investigational Site	Elblag		Poland	82-300
15	Novo Nordisk Investigational Site	Konskie		Poland	26-200
16	Novo Nordisk Investigational Site	Poznan		Poland	60-218
17	Novo Nordisk Investigational Site	Zyrardow		Poland	96-300
18	Novo Nordisk Investigational Site	Lisboa		Portugal	1649-035
19	Novo Nordisk Investigational Site	Cluj-Napoca	Cluj	Romania	400006
20	Novo Nordisk Investigational Site	Targoviste	Dambovita	Romania	130095
21	Novo Nordisk Investigational Site	Ploiesti	Prahova	Romania	100550
22	Novo Nordisk Investigational Site	Braila		Romania	810019
23	Novo Nordisk Investigational Site	A Coruña		Spain	15006
24	Novo Nordisk Investigational Site	Barcelona		Spain	08036
25	Novo Nordisk Investigational Site	Santiago de Compostela		Spain	15706
26	Novo Nordisk Investigational Site	Sevilla		Spain	41009
27	Novo Nordisk Investigational Site	Cambridge		United Kingdom	CB2 0QQ
28	Novo Nordisk Investigational Site	Leeds		United Kingdom	LS7 4SA
29	Novo Nordisk Investigational Site	Norwich		United Kingdom	NR4 7UY

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical Trials at Novo Nordisk

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01282255

Other Study ID Numbers:

NN8226-3875
U1111-1117-1136
2010-021283-14

First Posted:

Jan 24, 2011

Last Update Posted:

Feb 9, 2017

Last Verified:

Feb 1, 2017

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Inflammation

Study Results

No Results Posted as of Feb 9, 2017