InflammationPhase 2NCT01636843

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

A Phase 2 study testing NNC0109-0012 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 139 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Inflammation, Rheumatoid Arthritis
What is being tested?: NNC0109-0012
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 298 participants
Where: 139 sitesin 14 countries
Study dates: 30 Oct 2012to 10 Nov 2014
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Inclusion Criteria: - Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - A documented diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010 - Active RA, characterised by: a. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. C-reactive protein (CRP) above or equal to 1.0 mg/dL (10 mg/L) - Patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. Methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. Patient can be on MTX as low as 10 mg/week only if due to MTX intolerance b. Hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit Exclusion Criteria: - Patients with arthritis due to other autoimmune diseases than RA - Any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis) - History of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy - Patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit - Females of childbearing potential who are pregnant or breast feeding or intend to become pregnant - Any other disease or clinically significant abnormality in laboratory parameters which, according to the Investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective

Trial locations and contacts

139 sites in 14 countries.

Country

City, postcode or hospital

139 sites in 14 countries

United States29 sites

Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87102
Novo Nordisk Investigational Site
Beckley, West Virginia, 25801-2805
Novo Nordisk Investigational Site
Brooklyn, New York, 11201-4326
Novo Nordisk Investigational Site
Cedar Rapids, Iowa, 52401-2112
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28210
Novo Nordisk Investigational Site
Elizabethtown, Kentucky, 42701-2988
Novo Nordisk Investigational Site
Freehold, New Jersey, 07728
Novo Nordisk Investigational Site
Hagerstown, Maryland, 21740
Novo Nordisk Investigational Site
Houston, Texas, 77008
Novo Nordisk Investigational Site
Huntington Beach, California, 92646
Novo Nordisk Investigational Site
Jackson, Tennessee, 38305
Novo Nordisk Investigational Site
Kalispell, Montana, 59901
Novo Nordisk Investigational Site
La Mesa, California, 91942
Novo Nordisk Investigational Site
Lake Charles, Louisiana, 70601
Novo Nordisk Investigational Site
Lake Success, New York, 11042
Novo Nordisk Investigational Site
Los Angeles, California, 90022
Novo Nordisk Investigational Site
Memphis, Tennessee, 38119
Novo Nordisk Investigational Site
Mesquite, Texas, 75150-5615
Novo Nordisk Investigational Site
Norman, Oklahoma, 73069
Novo Nordisk Investigational Site
Orangeburg, South Carolina, 29118
Novo Nordisk Investigational Site
Palm Harbor, Florida, 34684
Novo Nordisk Investigational Site
Placentia, California, 92870
Novo Nordisk Investigational Site
Rock Island, Illinois, 61201
Novo Nordisk Investigational Site
South Bend, Indiana, 46601
Novo Nordisk Investigational Site
Springfield, Illinois, 62704
Novo Nordisk Investigational Site
St Louis, Missouri, 63117
Novo Nordisk Investigational Site
Toms River, New Jersey, 08755
Novo Nordisk Investigational Site
Upland, California, 91786
Novo Nordisk Investigational Site
Wichita, Kansas, 67206

Other trials in United States

Ukraine15 sites

Novo Nordisk Investigational Site
Donetsk, 83045
Novo Nordisk Investigational Site
Donetsk, 83114
Novo Nordisk Investigational Site
Ivano-Frankivsk, 76018
Novo Nordisk Investigational Site
Kharkiv, 61039
Novo Nordisk Investigational Site
Kharkiv, 61176
Novo Nordisk Investigational Site
Kiev, 1601
Novo Nordisk Investigational Site
Kyiv, 02232
Novo Nordisk Investigational Site
Luhansk, 91045
Novo Nordisk Investigational Site
Odesa, 65026
Novo Nordisk Investigational Site
Poltava, 36011
Novo Nordisk Investigational Site
Vinnytsia, 210029
Novo Nordisk Investigational Site
Vinnytsia, 21018
Novo Nordisk Investigational Site
Vinnytsia, 21029
Novo Nordisk Investigational Site
Zaporizhzhya, 69104
Novo Nordisk Investigational Site
Zaporizhzhya, 69600

Other trials in Ukraine

Russia13 sites

Novo Nordisk Investigational Site
Barnaul, 656024
Novo Nordisk Investigational Site
Barnaul, 656055
Novo Nordisk Investigational Site
Kemerovo, 193257
Novo Nordisk Investigational Site
Moscow, 115522
Novo Nordisk Investigational Site
Moscow, 119049
Novo Nordisk Investigational Site
Novosibirsk, 630008
Novo Nordisk Investigational Site
Petrozavodsk, 185019
Novo Nordisk Investigational Site
Saint Petersburg, 190068
Novo Nordisk Investigational Site
Saint Petersburg, 197341
Novo Nordisk Investigational Site
Smolensk, 214025
Novo Nordisk Investigational Site
Stavropol, 355017
Novo Nordisk Investigational Site
Yaroslavl, 150003
Novo Nordisk Investigational Site
Yekaterinburg, 620102

Other trials in Russia

Argentina12 sites

Novo Nordisk Investigational Site
Buenos Aires, B 1900AXI
Novo Nordisk Investigational Site
Buenos Aires, B1878GEG
Novo Nordisk Investigational Site
Buenos Aires, C1425DUH
Novo Nordisk Investigational Site
Buenos Aires, CA1199ABB
Novo Nordisk Investigational Site
Ciudad Autonoma Buenos Aires, 1113
Novo Nordisk Investigational Site
Ciudad Autonoma de Buenos Aire
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, 1194
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, C1204AAD
Novo Nordisk Investigational Site
Rosario, S2000PBJ
Novo Nordisk Investigational Site
San Juan, ZC:5400
Novo Nordisk Investigational Site
San Miguel de Tucumán, 4000
Novo Nordisk Investigational Site
San Miguel de Tucumán, T4000BRD

Other trials in Argentina

Brazil12 sites

Novo Nordisk Investigational Site
Cuiaba Mount, 78040.360
Novo Nordisk Investigational Site
Curitiba, Paraná, 80030-110
Novo Nordisk Investigational Site
Curitiba, 80440-080
Novo Nordisk Investigational Site
Juiz de Fora, Minas Gerais, 36010-570
Novo Nordisk Investigational Site
Rio de Janeiro, 22271-100
Novo Nordisk Investigational Site
Saint Oeste, Goiás, 74110-120
Novo Nordisk Investigational Site
São Paulo, São Paulo, 01244-030
Novo Nordisk Investigational Site
São Paulo, 01323-903
Novo Nordisk Investigational Site
São Paulo, 04266-010
Novo Nordisk Investigational Site
São Paulo, 05437-010
Novo Nordisk Investigational Site
Vila Clementino, São Paulo, 04026-000
Novo Nordisk Investigational Site
Vila Clementino, São Paulo, 04032-060

Other trials in Brazil

Mexico12 sites

Novo Nordisk Investigational Site
Chihuahua City, 31000
Novo Nordisk Investigational Site
Culiacán, Sinaloa, 80230
Novo Nordisk Investigational Site
Guadalajara, Jalisco, 44600
Novo Nordisk Investigational Site
México, México, D.F., 06700
Novo Nordisk Investigational Site
Mexico City, México, D.F., 06100
Novo Nordisk Investigational Site
Mexico City, 03100
Novo Nordisk Investigational Site
Mexico City, 07760
Novo Nordisk Investigational Site
Mexico City, C.P. 06700
Novo Nordisk Investigational Site
Monterrey, Nuevo León, 64000
Novo Nordisk Investigational Site
Monterrey N.L., 64000
Novo Nordisk Investigational Site
Roma, 06700
Novo Nordisk Investigational Site
San Luis Potosí City, 78200

Other trials in Mexico

Czechia9 sites

Novo Nordisk Investigational Site
Brno, 602 00
Novo Nordisk Investigational Site
Brno, 625 00
Novo Nordisk Investigational Site
Hlučín, 748 01
Novo Nordisk Investigational Site
Pardubice, 530 02
Novo Nordisk Investigational Site
Prague, 128 50
Novo Nordisk Investigational Site
Prague, 130 00
Novo Nordisk Investigational Site
Prague, 14000
Novo Nordisk Investigational Site
Prague, 148 00
Novo Nordisk Investigational Site
Zlín, 76001

Other trials in Czechia

Poland9 sites

Novo Nordisk Investigational Site
Bialystok, 15-879
Novo Nordisk Investigational Site
Gdynia, 81-384
Novo Nordisk Investigational Site
Katowice, 40-040
Novo Nordisk Investigational Site
Krakow, 30119
Novo Nordisk Investigational Site
Poznan, 60-218
Novo Nordisk Investigational Site
Środa Wielkopolska, 63-000
Novo Nordisk Investigational Site
Warsaw, 01-868
Novo Nordisk Investigational Site
Warsaw, 04-141
Novo Nordisk Investigational Site
Wroclaw, 50-381

Other trials in Poland

Germany7 sites

Novo Nordisk Investigational Site
Aachen, 52064
Novo Nordisk Investigational Site
Bad Kreuznach, 5543
Novo Nordisk Investigational Site
Frankfurt, 60528
Novo Nordisk Investigational Site
Hamburg, 22081
Novo Nordisk Investigational Site
Herne, 44649
Novo Nordisk Investigational Site
Koein, D-50937
Novo Nordisk Investigational Site
Vogelsang-Gommern, 39245

Other trials in Germany

Spain7 sites

Novo Nordisk Investigational Site
Guadalajara, 19002
Novo Nordisk Investigational Site
Madrid, 28942
Novo Nordisk Investigational Site
Málaga, 29009
Novo Nordisk Investigational Site
Seville, 41009
Novo Nordisk Investigational Site
Seville, 41010
Novo Nordisk Investigational Site
Seville, 41014
Novo Nordisk Investigational Site
Valencia, 46010

Other trials in Spain

Italy6 sites

Novo Nordisk Investigational Site
Arenzano, 16011
Novo Nordisk Investigational Site
Florence, 50139
Novo Nordisk Investigational Site
Genova, 16132
Novo Nordisk Investigational Site
Iesi, 60035
Novo Nordisk Investigational Site
Rome, 161
Novo Nordisk Investigational Site
Verona, 37134

Other trials in Italy

France4 sites

Novo Nordisk Investigational Site
Échirolles, 38130
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Orléans, 45032
Novo Nordisk Investigational Site
Rennes, 35033

Other trials in France

Belgium3 sites

Novo Nordisk Investigational Site
Anderlecht, 1070
Novo Nordisk Investigational Site
Kortrijk, 8500
Novo Nordisk Investigational Site
Liège, 4000

Other trials in Belgium

Hungary1 site

Novo Nordisk Investigational Site
Kiskunhalas, 6400

Other trials in Hungary

About this study

Official title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

Conditions: Inflammation, Rheumatoid Arthritis
Being tested: NNC0109-0012, placebo
Medical subject headings: Inflammation, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NNC0109-0012Drug
Administered subcutaneously (s.c., under the skin), once weekly.
placeboDrug
Administered subcutaneously (s.c., under the skin), once weekly.

Study groups in NCT01636843
Study group	Role	What they receive
60 mg	Experimental	Not described Receives: Drug: NNC0109-0012
120 mg	Experimental	Not described Receives: Drug: NNC0109-0012
240 mg	Experimental	Not described Receives: Drug: NNC0109-0012
Placebo	Experimental	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)
Measured: At week 12 (responder or non-responder)

Secondary outcomes (10)

ACR20, ACR50 and ACR70 improvement of ACR score from baseline
Measured: At weeks 12 and 24
Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline
Measured: At weeks 12 and 24
Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)
Measured: At weeks 12 and 24
European League Against Rheumatism (EULAR) criteria response
Measured: At weeks 12 and 24
Change from baseline in the overall scores of Short Form Health Survey (SF-36v2)
Measured: At weeks 12 and 24
Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI)
Measured: At weeks 12 and 24
Incidence and type of adverse events (AEs)
Measured: At weeks 12 and 24
Change from baseline in van der Heijde modified Sharp score
Measured: At weeks 12 and 24
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Measured: Week 52
Incidence and type of adverse events (AEs)
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 201210 Nov 2014

First posted10 Jul 2012 (estimated)
Study start30 Oct 2012
Primary completion10 Nov 2014
Study completion10 Nov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InflammationStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 298 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01636843
Sponsor's protocol ID: NN8226-3613
Other IDs: 2012-000610-11, U1111-1127-9324
Status last verified: Sep 2018
First submitted: 6 Jul 2012
Last updated: 5 Sep 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate
ClinicalTrials.gov ID: NCT01636843
Acronym / sponsor ID: NN8226-3613
Conditions: Inflammation, Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 298 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 30 Oct 2012 (actual)
Primary completion: 10 Nov 2014 (actual)
Study completion: 10 Nov 2014 (actual)
First posted: 10 Jul 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
60 mg	Experimental	Drug: NNC0109-0012
120 mg	Experimental	Drug: NNC0109-0012
240 mg	Experimental	Drug: NNC0109-0012
Placebo	Experimental	Drug: placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NNC0109-0012Administered subcutaneously (s.c., under the skin), once weekly.	Drug	120 mg, 240 mg, 60 mg
placeboAdministered subcutaneously (s.c., under the skin), once weekly.	Drug	Placebo

Primary outcome

ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)
Time frame: At week 12 (responder or non-responder)

10 secondary outcomes

ACR20, ACR50 and ACR70 improvement of ACR score from baseline
Time frame: At weeks 12 and 24
Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline
Time frame: At weeks 12 and 24
Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)
Time frame: At weeks 12 and 24
European League Against Rheumatism (EULAR) criteria response
Time frame: At weeks 12 and 24
Change from baseline in the overall scores of Short Form Health Survey (SF-36v2)
Time frame: At weeks 12 and 24
Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time frame: At weeks 12 and 24
Incidence and type of adverse events (AEs)
Time frame: At weeks 12 and 24
Change from baseline in van der Heijde modified Sharp score
Time frame: At weeks 12 and 24
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Time frame: Week 52
Incidence and type of adverse events (AEs)
Time frame: Week 52

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

139 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNC0109-0012 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 139 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, Ukraine, Russia, Argentina, Brazil and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) (time frame: At week 12 (responder or non-responder)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01636843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.