InflammationPhase 2NCT01282255
Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis
A Phase 2 study testing NNC109-0012 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 29 sites in 8 countries.
Trial 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). 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?
- NNC109-0012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 29 sitesin 8 countries
- Study dates
- Feb 2011to Jan 2012
- 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
- 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
Who cannot join
- 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)
Trial locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
Poland8 sites
Novo Nordisk Investigational Site
Bialystok, 15-296
Novo Nordisk Investigational Site
Bialystok, 15-351
Novo Nordisk Investigational Site
Bydgoszcz, 85-021
Novo Nordisk Investigational Site
Bytom, 41-902
Novo Nordisk Investigational Site
Elblag, 82-300
Novo Nordisk Investigational Site
Gmina Końskie, 26-200
Novo Nordisk Investigational Site
Poznan, 60-218
Novo Nordisk Investigational Site
Żyrardów, 96-300
Czechia5 sites
Novo Nordisk Investigational Site
Brno, 602 00
Novo Nordisk Investigational Site
Prague, 128 50
Novo Nordisk Investigational Site
Prague, 140 00
Novo Nordisk Investigational Site
Uherské Hradiště, 686 01
Novo Nordisk Investigational Site
Zlín, 760 01
Romania4 sites
Novo Nordisk Investigational Site
Brăila, 810019
Novo Nordisk Investigational Site
Cluj-Napoca, Cluj, 400006
Novo Nordisk Investigational Site
Ploieşti, Prahova, 100550
Novo Nordisk Investigational Site
Targoviste, Dâmbovița County, 130095
Spain4 sites
Novo Nordisk Investigational Site
A Coruña, 15006
Novo Nordisk Investigational Site
Barcelona, 08036
Novo Nordisk Investigational Site
Santiago de Compostela, 15706
Novo Nordisk Investigational Site
Seville, 41009
Germany3 sites
Novo Nordisk Investigational Site
Berlin, 14059
Novo Nordisk Investigational Site
Mainz, 55131
Novo Nordisk Investigational Site
Würzburg, 97080
United Kingdom3 sites
Novo Nordisk Investigational Site
Cambridge, CB2 0QQ
Novo Nordisk Investigational Site
Leeds, LS7 4SA
Novo Nordisk Investigational Site
Norwich, NR4 7UY
About this study
Official title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis
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).
- Conditions
- Inflammation, Rheumatoid Arthritis
- Being tested
- NNC109-0012, 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.
NNC109-0012Drug
The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)
placeboDrug
The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: NNC109-0012 |
| B | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)
Measured: week 0, week 12
Secondary outcomes (2)
Terminal serum half-life (t½)
Measured: end of treatment period
Serum levels of NNC109-0012
Measured: end of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 67 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
- NCT01282255
- Sponsor's protocol ID
- NN8226-3875
- Other IDs
- U1111-1117-1136, 2010-021283-14
- Status last verified
- Feb 2017
- First submitted
- 21 Jan 2011
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25749867Senolt 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.
PubMed 25707477
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01282255
- Acronym / sponsor ID
- NN8226-3875
- Conditions
- Inflammation, Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 Jan 2011 (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. 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: NNC109-0012 |
| B | 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 (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| NNC109-0012The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin) | Drug | A |
| placeboThe subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin) | Drug | B |
Primary outcome
Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)
Time frame: week 0, week 12
2 secondary outcomes
Terminal serum half-life (t½)
Time frame: end of treatment period
Serum levels of NNC109-0012
Time frame: end of treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Results publication: PubMed 25749867Lundblad 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 publication: PubMed 25707477Senolt 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.
- 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
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC109-0012 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 29 sites in 8 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Poland, Czechia, Romania, Spain, Germany and 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value) (time frame: week 0, week 12). 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 NCT01282255, which also lists 2 linked publications.
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 9 Feb 2017.