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Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

Primary Purpose

Inflammation, Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

NNC109-0012

placebo

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Terminal serum half-life (t½)

Serum levels of NNC109-0012

Full Information

NCT ID

NCT01282255

First Posted

January 21, 2011

Last Updated

February 8, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01282255

Brief Title

Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

NNC109-0012

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

week 0, week 12

Secondary Outcome Measure Information:

Title

Terminal serum half-life (t½)

Time Frame

end of treatment period

Title

Serum levels of NNC109-0012

Time Frame

end of treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Brno

ZIP/Postal Code

602 00

Country

Czech Republic

Facility Name

Novo Nordisk Investigational Site

City

Praha 2

ZIP/Postal Code

128 50

Country

Czech Republic

Facility Name

Novo Nordisk Investigational Site

City

Praha

ZIP/Postal Code

140 00

Country

Czech Republic

Facility Name

Novo Nordisk Investigational Site

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czech Republic

Facility Name

Novo Nordisk Investigational Site

City

Zlin

ZIP/Postal Code

760 01

Country

Czech Republic

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

ZIP/Postal Code

15-296

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-021

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Konskie

ZIP/Postal Code

26-200

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Poznan

ZIP/Postal Code

60-218

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Zyrardow

ZIP/Postal Code

96-300

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400006

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Targoviste

State/Province

Dambovita

ZIP/Postal Code

130095

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Ploiesti

State/Province

Prahova

ZIP/Postal Code

100550

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Braila

ZIP/Postal Code

810019

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Leeds

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Norwich

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25749867

Citation

Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.

Results Reference

result

PubMed Identifier

25707477

Citation

Senolt L, Leszczynski P, Dokoupilova E, Gothberg M, Valencia X, Hansen BB, Canete JD. Efficacy and Safety of Anti-Interleukin-20 Monoclonal Antibody in Patients With Rheumatoid Arthritis: A Randomized Phase IIa Trial. Arthritis Rheumatol. 2015 Jun;67(6):1438-48. doi: 10.1002/art.39083.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

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Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

Inflammation, Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial