InflammationPhase 2NCT01647451
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
A Phase 2 study testing NNC0114-0006 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 33 sites in 7 countries.
Trial summary
This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy. 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?
- NNC0114-0006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 33 sitesin 7 countries
- Study dates
- Sep 2012to Aug 2013
- 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
- A diagnosis of RA meeting the 2010 ACR (American College of Rheumatology) classification criteria, obtained at least 6 months prior to dosing with the trial product. (If the diagnosis was made prior to 2010, a diagnosis meeting the 1987 ACR classification criteria is acceptable)
- Active RA characterised by DAS28-CRP (disease activity score based on 28 joints and c-reactive protein) equal to or above 4.5 and at least five tender and five swollen joints (can be the same joints) of the 28 joint count
- Concomitant treatment with MTX above or equal to 15 mg/week for at least 4 months prior to screening, with stable dose of between or equal to 15 mg/week and 25 mg/week for at least 6 weeks prior to screening (MTX doses between 7.5 and 12.5 mg/week are allowed, if patient had intolerance to 15 mg/week)
- Biologic naïve subjects or subjects having been treated with biologics for RA (biologic experienced) provided they meet one of the following criteria: a. Reason for discontinuation of biologic therapy was intolerance (e.g., unable to receive recommended doses or achieve adequate treatment duration because of drug related side effects), b. Discontinued biologic therapy for other reasons than lack of efficacy (primary or secondary failure) or intolerance (e.g., drug holiday)
Who cannot join
- Body mass index (BMI) below or equal to 18.0 or above or equal to 38.0 kg/m^2
- Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome). Subjects with secondary Sjögren's syndrome or stable hypothyroidism are eligible
- Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy (e.g., simple urinary tract infection)
- Any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
- History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
Russia8 sites
Novo Nordisk Investigational Site
Kazan', 420103
Novo Nordisk Investigational Site
Kursk, 305007
Novo Nordisk Investigational Site
Moscow, 119991
Novo Nordisk Investigational Site
Skt Petersburg, 194044
Novo Nordisk Investigational Site
Skt Petersburg, 196084
Novo Nordisk Investigational Site
Skt. Petersburg, 191025
Novo Nordisk Investigational Site
Skt. Petersburg, 191186
Novo Nordisk Investigational Site
Yaroslavl, 150051
Poland7 sites
Novo Nordisk Investigational Site
Bialystok, 15-351
Novo Nordisk Investigational Site
Bydgoszcz, 85-168
Novo Nordisk Investigational Site
Bytom, 41-902
Novo Nordisk Investigational Site
Elblag, 82-300
Novo Nordisk Investigational Site
Katowice, 40-954
Novo Nordisk Investigational Site
Poznan, 60-218
Novo Nordisk Investigational Site
Warsaw, 02-256
Bulgaria5 sites
Novo Nordisk Investigational Site
Plovdiv, 4002
Novo Nordisk Investigational Site
Sevlievo, 5400
Novo Nordisk Investigational Site
Sofia, 1233
Novo Nordisk Investigational Site
Sofia, 1606
Novo Nordisk Investigational Site
Sofia, 1612
Hungary5 sites
Novo Nordisk Investigational Site
Budapest, 1036
Novo Nordisk Investigational Site
Debrecen, 4032
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Szikszó, 3800
Novo Nordisk Investigational Site
Veszprém, 8200
Spain4 sites
Novo Nordisk Investigational Site
A Coruña, 15006
Novo Nordisk Investigational Site
Barcelona, 08036
Novo Nordisk Investigational Site
Elche, 3203
Novo Nordisk Investigational Site
Seville, 41013
Serbia3 sites
Novo Nordisk Investigational Site
Belgrade, 11000
Novo Nordisk Investigational Site
Belgrade, 11080
Novo Nordisk Investigational Site
Niška Banja, 18205
About this study
This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.
- Conditions
- Inflammation, Rheumatoid Arthritis
- Being tested
- NNC0114-0006, 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.
NNC0114-0006Drug
Two i.v. (intravenous) doses administered 6 weeks apart.
placeboDrug
Two i.v. (intravenous) doses administered 6 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: NNC0114-0006 |
| 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.
Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP)
Measured: Week 0, week 12
Secondary outcomes (6)
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Measured: Week 12
Incidence of adverse events (AEs)
Measured: Up to week 24
Incidence of antibodies against NNC0114-0006
Measured: Up to Week 24
Terminal serum half-life (t½)
Measured: After second dose administration at week 6
Change in serum levels of total interleukin-21 (IL-21)
Measured: Up to week 12
Change in Health Assessment Questionnaire - Disability Index score (HAQ-DI)
Measured: Week 0, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 62 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
- NCT01647451
- Sponsor's protocol ID
- NN8828-3842
- Other IDs
- 2011-005376-42, U1111-1125-6552
- Status last verified
- Feb 2017
- First submitted
- 19 Jul 2012
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Canete J, Leszczynski P, Riisbro R, Frederiksen K. Efficacy and safety of NNC0114-0006, an anti-IL-21 monoclonal antibody, in patients with active rheumatoid arthritis. Arthritis and Rheumatology; 66 (10 (Supplement)): Abstract 947
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01647451
- Acronym / sponsor ID
- NN8828-3842
- Conditions
- Inflammation, Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 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. The aim of the trial is to evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: NNC0114-0006 |
| 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)
- A diagnosis of RA meeting the 2010 ACR (American College of Rheumatology) classification criteria, obtained at least 6 months prior to dosing with the trial product. (If the diagnosis was made prior to 2010, a diagnosis meeting the 1987 ACR classification criteria is acceptable)
- Active RA characterised by DAS28-CRP (disease activity score based on 28 joints and c-reactive protein) equal to or above 4.5 and at least five tender and five swollen joints (can be the same joints) of the 28 joint count
- Concomitant treatment with MTX above or equal to 15 mg/week for at least 4 months prior to screening, with stable dose of between or equal to 15 mg/week and 25 mg/week for at least 6 weeks prior to screening (MTX doses between 7.5 and 12.5 mg/week are allowed, if patient had intolerance to 15 mg/week)
- Biologic naïve subjects or subjects having been treated with biologics for RA (biologic experienced) provided they meet one of the following criteria: a. Reason for discontinuation of biologic therapy was intolerance (e.g., unable to receive recommended doses or achieve adequate treatment duration because of drug related side effects), b. Discontinued biologic therapy for other reasons than lack of efficacy (primary or secondary failure) or intolerance (e.g., drug holiday)
Key exclusion criteria (5 listed)
- Body mass index (BMI) below or equal to 18.0 or above or equal to 38.0 kg/m^2
- Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome). Subjects with secondary Sjögren's syndrome or stable hypothyroidism are eligible
- Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy (e.g., simple urinary tract infection)
- Any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
- History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy
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 |
|---|---|---|
| NNC0114-0006Two i.v. (intravenous) doses administered 6 weeks apart. | Drug | Active |
| placeboTwo i.v. (intravenous) doses administered 6 weeks apart. | Drug | Placebo |
Primary outcome
Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP)
Time frame: Week 0, week 12
6 secondary outcomes
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Time frame: Week 12
Incidence of adverse events (AEs)
Time frame: Up to week 24
Incidence of antibodies against NNC0114-0006
Time frame: Up to Week 24
Terminal serum half-life (t½)
Time frame: After second dose administration at week 6
Change in serum levels of total interleukin-21 (IL-21)
Time frame: Up to week 12
Change in Health Assessment Questionnaire - Disability Index score (HAQ-DI)
Time frame: Week 0, week 12
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 7 Feb 2017.
- Results publicationCanete J, Leszczynski P, Riisbro R, Frederiksen K. Efficacy and safety of NNC0114-0006, an anti-IL-21 monoclonal antibody, in patients with active rheumatoid arthritis. Arthritis and Rheumatology; 66 (10 (Supplement)): Abstract 947
- 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
33 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC0114-0006 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 33 sites in 7 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 5 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 7 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 33 sites in Russia, Poland, Bulgaria, Hungary, Spain and 2 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 disease activity score based on 28 joints and c-reactive protein (DAS28-CRP) (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 NCT01647451, which also lists 1 linked publication.
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 7 Feb 2017.