InflammationPhase 2NCT01223911
A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
A Phase 2 study testing NNC 0151-0000-0000 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 16 sites in 6 countries.
Trial summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with 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?
- NNC 0151-0000-0000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 16 sitesin 6 countries
- Study dates
- Jan 2011to Feb 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
- CZ: Age between 18 and 65 years (both inclusive)
- A diagnosis of rheumatoid arthritis of at least three months before entry in trial
- Active rheumatoid arthritis (RA)
- Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration
Who cannot join
- Known or suspected allergy to trial product or related products
- Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
Romania5 sites
Novo Nordisk Investigational Site
Bacau, Bacău, 600114
Novo Nordisk Investigational Site
Bucharest, 011172
Novo Nordisk Investigational Site
Bucharest, 020475
Novo Nordisk Investigational Site
Cluj-Napoca, Cluj, 400006
Novo Nordisk Investigational Site
Sfantu Gheorghe, Covasna, 520064
Poland4 sites
Novo Nordisk Investigational Site
Bialystok, 15-879
Novo Nordisk Investigational Site
Elblag, 82-300
Novo Nordisk Investigational Site
Krakow, 31-637
Novo Nordisk Investigational Site
Poznan, 61-218
United Kingdom3 sites
Novo Nordisk Investigational Site
Burslem, ST6 7AG
Novo Nordisk Investigational Site
Newcastle upon Tyne, NE1 4LP
Novo Nordisk Investigational Site
Swansea, SA6 6NL
Denmark2 sites
Novo Nordisk Investigational Site
Frederiksberg, 2000
Novo Nordisk Investigational Site
Silkeborg, 8600
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).
- Conditions
- Inflammation, Rheumatoid Arthritis
- Being tested
- NNC 0151-0000-0000, 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.
NNC 0151-0000-0000Drug
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
placeboDrug
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: NNC 0151-0000-0000 |
| 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.
Number of adverse events (AEs)
Measured: at all scheduled visits (week 1 - week 11)
Secondary outcomes (1)
Serum concentrations of NNC 151-0000-0000
Measured: at 48 hours after all dose administrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2013
- Study completionFeb 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
- 34 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
- NCT01223911
- Sponsor's protocol ID
- NN8209-3607
- Other IDs
- U1111-1116-2430, 2009-011791-30, 2009
- Status last verified
- Feb 2017
- First submitted
- 14 Oct 2010
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Daniluk S, Skrumsager BK, Leszczynski P. Safety and tolerability of the anti-C5aR humanised monoclonal antibody NNC0151-0000 in patients with rheumatoid arthritis: A phase 2, randomised, double-blind, placebocontrolled, multiple-dose trial. EULAR (European League Against Rheumatism) 2014; Country: France City: Paris
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 NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01223911
- Acronym / sponsor ID
- NN8209-3607
- Conditions
- Inflammation, Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Oct 2010 (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 clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with 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: NNC 0151-0000-0000 |
| 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 (4 listed)
- CZ: Age between 18 and 65 years (both inclusive)
- A diagnosis of rheumatoid arthritis of at least three months before entry in trial
- Active rheumatoid arthritis (RA)
- Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration
Key exclusion criteria (2 listed)
- Known or suspected allergy to trial product or related products
- Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)
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 |
|---|---|---|
| NNC 0151-0000-0000Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period | Drug | A |
| placeboMultiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period | Drug | B |
Primary outcome
Number of adverse events (AEs)
Time frame: at all scheduled visits (week 1 - week 11)
1 secondary outcome
Serum concentrations of NNC 151-0000-0000
Time frame: at 48 hours after all dose administrations
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 publicationDaniluk S, Skrumsager BK, Leszczynski P. Safety and tolerability of the anti-C5aR humanised monoclonal antibody NNC0151-0000 in patients with rheumatoid arthritis: A phase 2, randomised, double-blind, placebocontrolled, multiple-dose trial. EULAR (European League Against Rheumatism) 2014; Country: France City: Paris
- 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
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC 0151-0000-0000 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 16 sites in 6 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 2 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 16 sites in Romania, Poland, United Kingdom, Denmark, Czechia and 1 more country. 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?
Number of adverse events (AEs) (time frame: at all scheduled visits (week 1 - week 11)). 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 NCT01223911, 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 9 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.