InflammationPhase 2NCT01636817
A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics
A Phase 2 study testing NNC0109-0012 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 164 sites in 13 countries.
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 s.c. 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
- 239 participants
- Where
- 164 sitesin 13 countries
- Study dates
- Aug 2012to 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
Who may be able to join
- 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. above 5 tender and above 5 swollen joints based on a 28 joint count b. CRP (C-reactive protein) above or equal to 1.0 mg/dL (10 mg/L)
- Patients must be anti-TNF (anti-Tumour Necrosis Factor) inadequate responders to at least one but not more than two anti-TNF biologics with active disease documented in medical records at the time of discontinuation
Who cannot join
- 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
164 sites in 13 countries.
164 sites in 13 countries
United States92 sites
Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87102
Novo Nordisk Investigational Site
Amarillo, Texas, 79124
Novo Nordisk Investigational Site
Ann Arbor, Michigan, 48109-0100
Novo Nordisk Investigational Site
Arlington, Virginia, 22205
Novo Nordisk Investigational Site
Austin, Texas, 78721
Novo Nordisk Investigational Site
Baltimore, Maryland, 21239
Novo Nordisk Investigational Site
Battle Creek, Michigan, 49018
Novo Nordisk Investigational Site
Beckley, West Virginia, 25801-2805
Novo Nordisk Investigational Site
Bend, Oregon, 97701
Novo Nordisk Investigational Site
Boca Raton, Florida, 33486
Novo Nordisk Investigational Site
Brooklyn, New York, 11201-4326
Novo Nordisk Investigational Site
Carrollton, Texas, 75007
Novo Nordisk Investigational Site
Cedar Rapids, Iowa, 52401-2112
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27599
Novo Nordisk Investigational Site
Charleston, South Carolina, 29406
Novo Nordisk Investigational Site
Charleston, South Carolina, 29407-7757
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28210
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45219
Novo Nordisk Investigational Site
Clifton, New Jersey, 07012
Novo Nordisk Investigational Site
Columbia, Maryland, 21045
Novo Nordisk Investigational Site
Columbia, South Carolina, 29204-2409
Novo Nordisk Investigational Site
Columbus, Ohio, 43203
Novo Nordisk Investigational Site
Cumberland, Maryland, 21502
Novo Nordisk Investigational Site
Decatur, Georgia, 30033
Novo Nordisk Investigational Site
Elizabethtown, Kentucky, 42701-2988
Novo Nordisk Investigational Site
Flowood, Mississippi, 39232-9306
Novo Nordisk Investigational Site
Flowood, Mississippi, 39232
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, 33334
Novo Nordisk Investigational Site
Freehold, New Jersey, 07728
Novo Nordisk Investigational Site
Gainesville, Florida, 32607
Novo Nordisk Investigational Site
Glendale, California, 91204
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Hagerstown, Maryland, 21740
Novo Nordisk Investigational Site
Hemet, California, 92543
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033-2360
Novo Nordisk Investigational Site
Houston, Texas, 77008
Novo Nordisk Investigational Site
Houston, Texas, 77034
Novo Nordisk Investigational Site
Houston, Texas, 77090
Novo Nordisk Investigational Site
Huntington Beach, California, 92646
Novo Nordisk Investigational Site
Huntsville, Alabama, 35801
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404
Novo Nordisk Investigational Site
Jackson, Tennessee, 38305
Novo Nordisk Investigational Site
Jupiter, Florida, 33468
Novo Nordisk Investigational Site
Kansas City, Kansas, 66160
Novo Nordisk Investigational Site
La Mesa, California, 91942
Novo Nordisk Investigational Site
Lake Charles, Louisiana, 70601
Novo Nordisk Investigational Site
Lake Oswego, Oregon, 07035
Novo Nordisk Investigational Site
Lake Success, New York, 11042
Novo Nordisk Investigational Site
Lakewood, California, 90712
Novo Nordisk Investigational Site
Lincoln, Nebraska, 68516
Novo Nordisk Investigational Site
Long Beach, California, 90806
Novo Nordisk Investigational Site
Long Beach, California, 90808-2146
Novo Nordisk Investigational Site
Los Angeles, California, 90022
Novo Nordisk Investigational Site
McKinney, Texas, 75071
Novo Nordisk Investigational Site
Memphis, Tennessee, 38104
Novo Nordisk Investigational Site
Memphis, Tennessee, 38119
Novo Nordisk Investigational Site
Mesa, Arizona, 85202
Novo Nordisk Investigational Site
New Port Richey, Florida, 34652
Novo Nordisk Investigational Site
Norman, Oklahoma, 73069
Novo Nordisk Investigational Site
Ocala, Florida, 34474
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73103
Novo Nordisk Investigational Site
Orangeburg, South Carolina, 29118
Novo Nordisk Investigational Site
Orlando, Florida, 32804
Novo Nordisk Investigational Site
Phoenix, Arizona, 85037
Novo Nordisk Investigational Site
Placentia, California, 92870
Novo Nordisk Investigational Site
Raleigh, North Carolina, 27617
Novo Nordisk Investigational Site
Rock Island, Illinois, 61201
Novo Nordisk Investigational Site
San Diego, California, 92101
Novo Nordisk Investigational Site
Santa Monica, California, 90409
Novo Nordisk Investigational Site
Scottsdale, Arizona, 85258-4523
Novo Nordisk Investigational Site
Seattle, Washington, 98122
Novo Nordisk Investigational Site
Shreveport, Louisiana, 71105
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
St Louis, Missouri, 63139-2338
Novo Nordisk Investigational Site
St Louis, Missouri, 63141-6819
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Tacoma, Washington, 98405
Novo Nordisk Investigational Site
Tampa, Florida, 33613
Novo Nordisk Investigational Site
Toledo, Ohio, 43606
Novo Nordisk Investigational Site
Toms River, New Jersey, 08755
Novo Nordisk Investigational Site
Tulsa, Oklahoma, 74135
Novo Nordisk Investigational Site
Tuscaloosa, Alabama, 35406
Novo Nordisk Investigational Site
Upland, California, 91786
Novo Nordisk Investigational Site
Venice, Florida, 34292
Novo Nordisk Investigational Site
Waco, Texas, 76708-3244
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33407
Novo Nordisk Investigational Site
Wichita, Kansas, 67206
Novo Nordisk Investigational Site
Wilmington, North Carolina, 28401-6442
Novo Nordisk Investigational Site
Worcester, Massachusetts, 01605
Brazil10 sites
Novo Nordisk Investigational Site
Cuiabá - Mount, 78040-360
Novo Nordisk Investigational Site
Curitiba, 80440-080
Novo Nordisk Investigational Site
Juiz de Fora, Minas Gerais, 36010-570
Novo Nordisk Investigational Site
Rio Grande de Sul, 91350-200
Novo Nordisk Investigational Site
Saint Oeste, Goiás, 74110-120
Novo Nordisk Investigational Site
Santa Efigenia-Belo Horizonte, Minas Gerais, 30150-221
Novo Nordisk Investigational Site
São Paulo, São Paulo, 01244-030
Novo Nordisk Investigational Site
São Paulo, 04266-010
Novo Nordisk Investigational Site
Vila Clementino, São Paulo, 04026-000
Novo Nordisk Investigational Site
Vila Clementino, São Paulo, 04032-060
Mexico10 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
Mexico City, México, D.F., 06100
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
Argentina9 sites
Novo Nordisk Investigational Site
Buenos Aires, B 1900AXI
Novo Nordisk Investigational Site
Buenos Aires, B1878GEG
Novo Nordisk Investigational Site
Buenos Aires, CA1199ABB
Novo Nordisk Investigational Site
Ciudad Autonoma de Buenos Aire
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, 1194
Novo Nordisk Investigational Site
Córdoba, X5002HWE
Novo Nordisk Investigational Site
Rosario, S2000PBJ
Novo Nordisk Investigational Site
San Juan, ZC:5400
Novo Nordisk Investigational Site
San Miguel de Tucumán, 4000
France7 sites
Novo Nordisk Investigational Site
Bois-Guillaume, 76230
Novo Nordisk Investigational Site
Bordeaux, 35033
Novo Nordisk Investigational Site
Échirolles, 38130
Novo Nordisk Investigational Site
Lyon, 69437
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Orléans, 45032
Novo Nordisk Investigational Site
Rennes, 35033
Italy7 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
Torrette Di Ancona, 60126
Novo Nordisk Investigational Site
Verona, 37134
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
Germany6 sites
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
United Kingdom5 sites
Novo Nordisk Investigational Site
Barnsley, S75 2EP
Novo Nordisk Investigational Site
Eastbourne, BN21 2UD
Novo Nordisk Investigational Site
Maidstone, ME169QQ
Novo Nordisk Investigational Site
Sheffield, SJO 2SJ
Novo Nordisk Investigational Site
Wolverhampton, WV10 0QP
Belgium3 sites
Novo Nordisk Investigational Site
Anderlecht, 1070
Novo Nordisk Investigational Site
Kortrijk, 8500
Novo Nordisk Investigational Site
Liège, 4000
Czechia3 sites
Novo Nordisk Investigational Site
Hlučín, 748 01
Novo Nordisk Investigational Site
Prague, 128 50
Novo Nordisk Investigational Site
Zlín, 76001
Poland3 sites
Novo Nordisk Investigational Site
Krakow, 30119
Novo Nordisk Investigational Site
Poznan, 61-218
Novo Nordisk Investigational Site
Środa Wielkopolska, 63-000
Hungary2 sites
Novo Nordisk Investigational Site
Debrecen, 4031
Novo Nordisk Investigational Site
Veszprém, 8200
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 Anti-TNFa Biologics
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 s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.
- 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 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 | Placebo comparator | 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 (i.e., responder or non-responder)
Secondary outcomes (10)
20%/50%/or 70% 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 Health Assessment Questionnaire - Disability Index (HAQ-DI)
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
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.
- First posted10 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2014
- Study completionNov 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
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636817
- Sponsor's protocol ID
- NN8226-3612
- Other IDs
- 2012-000609-58, U1111-1127-9273
- Status last verified
- Sep 2018
- First submitted
- 6 Jul 2012
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
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 Anti-TNFa Biologics
- ClinicalTrials.gov ID
- NCT01636817
- Acronym / sponsor ID
- NN8226-3612
- Conditions
- Inflammation, Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- 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.
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 s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.
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 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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. above 5 tender and above 5 swollen joints based on a 28 joint count b. CRP (C-reactive protein) above or equal to 1.0 mg/dL (10 mg/L)
- Patients must be anti-TNF (anti-Tumour Necrosis Factor) inadequate responders to at least one but not more than two anti-TNF biologics with active disease documented in medical records at the time of discontinuation
Key exclusion criteria (6 listed)
- 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
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 (i.e., responder or non-responder)
10 secondary outcomes
20%/50%/or 70% 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 Health Assessment Questionnaire - Disability Index (HAQ-DI)
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
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
164 sites in 13 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 164 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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 164 sites in United States, Brazil, Mexico, Argentina, France and 8 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. Some participants in this study may receive a placebo. 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 (i.e., responder or non-responder)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.