InflammationPhase 2NCT02097264
A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
A Phase 2 study testing NNC0109-0012 and Adalimumab in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis (RA) and an inadequate response to Methotrexate. 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 and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2015
- 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
- Male or female age at least 18 and below or equal to 75 years at the time of signing informed consent
- A 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
- Subjects with ACR global functional status of 1 to 3
- Active RA, characterised by: DAS28 (Disease Activity Score 28) (CRP (C-reactive protein)) above 4.5 and equal to or above 6 tender and equal to or above 6 swollen joints based on a 66/68 joint count
- Active Synovitis in at least two joints of the wrist and metacarpophalangeal joints, as assessed by high frequency Power Doppler ultrasound scan at screening and randomisation
Who cannot join
- Subjects with arthritis due to other autoimmune diseases than RA
- Body weight above 90.0 kg
- History of or current inflammatory joint disease other than RA (e.g. gout, psoriatic or reactive arthritis, Lyme disease, juvenile idiopathic arthritis, excluding secondary Sjogren syndrome and hypothyroidism)
- Any active or on-going 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)
- Subjects with 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
- Female who is pregnant, breast feeding, intends to become pregnant or is of childbearing potential, not willing to use two highly effective contraceptive methods (adequate highlyeffective contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system) one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream), for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
- Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of highly effective contraception, one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
About this study
Official title: A Randomised, Active Comparator, Double-blind, Multi Centre, Parallel, Phase 2a Trial, Investigating the Mechanism of Action, of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
This trial is conducted in Europe. The aim of the trial is to investigate the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis (RA) and an inadequate response to Methotrexate.
- Conditions
- Inflammation, Rheumatoid Arthritis
- Being tested
- NNC0109-0012, Adalimumab, 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
Solution for injection administered subcutaneously (s.c. - under the skin). 240 mg NNC0109-0012 will be administered weekly for 12 weeks
AdalimumabDrug
Solution for injection administered subcutaneously (s.c. - under the skin). Administered every other week for 12 weeks; Each active treatment involves 1 (one) s.c. injection of adalimumab 40 mg/0,8 mL solution for injection for paediatric use (Humira®)
placeboDrug
Solution for injection administered subcutaneously (s.c. - under the skin).
1 active adalimumab injection and 2 placebo injections per active treatment (every other week), and 3 placebo injections on placebo visits (alternative weeks).
| Study group | Role | What they receive |
|---|---|---|
| NNC0109-0012 | Experimental | Not described Receives: Drug: NNC0109-0012; Drug: placebo |
| Adalimumab | Active comparator | Not described Receives: Drug: Adalimumab; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total histopathological synovitis score
Measured: Week 0, week 12
Secondary outcomes (10)
Change in dynamic contrast enhanced MRI (DCE-MRI) measures of initial rate of enhancement (IRE)
Measured: Week 0, week 12
Change in dynamic contrast enhanced MRI (DCE-MRI) measures of maximal enhancement (ME)
Measured: Week 0, week 12
Changes in RA-MRI scores (RAMRIS (Rheumatoid arthritis magnetic resonance imaging)) of synovitis
Measured: Week 0, week 12
Changes in RA-MRI scores (RAMRIS) of oedema
Measured: Week 0, week 12
Changes in RA-MRI scores (RAMRIS) of erosion
Measured: Week 0, week 12
Change in high frequency ultrasound with Power Doppler measures of total synovitis
Measured: Week 0, week 12
Change in high frequency ultrasound with Power Doppler measures of total tenosynovitis scores
Measured: Week 0, week 12
Change in disease activity 28 - C-reactive protein (DAS28 (CRP)
Measured: Week 0, week 12
Incidence of Adverse Events (AE)
Measured: Week 0, week 24
Incidence of local intolerability at the injection site
Measured: Week 0, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
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
- 0 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
- NCT02097264
- Sponsor's protocol ID
- NN8226-4064
- Other IDs
- 2013-001492-20, U1111-1141-3512, REec-2014-0740
- Status last verified
- Aug 2014
- First submitted
- 24 Mar 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Active Comparator, Double-blind, Multi Centre, Parallel, Phase 2a Trial, Investigating the Mechanism of Action, of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
- ClinicalTrials.gov ID
- NCT02097264
- Acronym / sponsor ID
- NN8226-4064
- Conditions
- Inflammation, Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 27 Mar 2014 (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 investigate the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis (RA) and an inadequate response to Methotrexate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0109-0012 | Experimental | Drug: NNC0109-0012, Drug: placebo |
| Adalimumab | Active comparator | Drug: Adalimumab, Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female age at least 18 and below or equal to 75 years at the time of signing informed consent
- A 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
- Subjects with ACR global functional status of 1 to 3
- Active RA, characterised by: DAS28 (Disease Activity Score 28) (CRP (C-reactive protein)) above 4.5 and equal to or above 6 tender and equal to or above 6 swollen joints based on a 66/68 joint count
- Active Synovitis in at least two joints of the wrist and metacarpophalangeal joints, as assessed by high frequency Power Doppler ultrasound scan at screening and randomisation
Key exclusion criteria (7 listed)
- Subjects with arthritis due to other autoimmune diseases than RA
- Body weight above 90.0 kg
- History of or current inflammatory joint disease other than RA (e.g. gout, psoriatic or reactive arthritis, Lyme disease, juvenile idiopathic arthritis, excluding secondary Sjogren syndrome and hypothyroidism)
- Any active or on-going 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)
- Subjects with 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
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 |
|---|---|---|
| NNC0109-0012Solution for injection administered subcutaneously (s.c. - under the skin). 240 mg NNC0109-0012 will be administered weekly for 12 weeks | Drug | NNC0109-0012 |
| AdalimumabSolution for injection administered subcutaneously (s.c. - under the skin). Administered every other week for 12 weeks; Each active treatment involves 1 (one) s.c. injection of adalimumab 40 mg/0,8 mL solution for injection for paediatric use (Humira®) | Drug | Adalimumab |
| placeboSolution for injection administered subcutaneously (s.c. - under the skin). 1 active adalimumab injection and 2 placebo injections per active treatment (every other week), and 3 placebo injections on placebo visits (alternative weeks). | Drug | Adalimumab, NNC0109-0012 |
Primary outcome
Change in the total histopathological synovitis score
Time frame: Week 0, week 12
10 secondary outcomes
Change in dynamic contrast enhanced MRI (DCE-MRI) measures of initial rate of enhancement (IRE)
Time frame: Week 0, week 12
Change in dynamic contrast enhanced MRI (DCE-MRI) measures of maximal enhancement (ME)
Time frame: Week 0, week 12
Changes in RA-MRI scores (RAMRIS (Rheumatoid arthritis magnetic resonance imaging)) of synovitis
Time frame: Week 0, week 12
Changes in RA-MRI scores (RAMRIS) of oedema
Time frame: Week 0, week 12
Changes in RA-MRI scores (RAMRIS) of erosion
Time frame: Week 0, week 12
Change in high frequency ultrasound with Power Doppler measures of total synovitis
Time frame: Week 0, week 12
Change in high frequency ultrasound with Power Doppler measures of total tenosynovitis scores
Time frame: Week 0, week 12
Change in disease activity 28 - C-reactive protein (DAS28 (CRP)
Time frame: Week 0, week 12
Incidence of Adverse Events (AE)
Time frame: Week 0, week 24
Incidence of local intolerability at the injection site
Time frame: Week 0, week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC0109-0012 and Adalimumab in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 the total histopathological synovitis score (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?
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 15 Aug 2014.