InflammationPhase 2NCT01181050

Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)

A Phase 2 study testing NNC0142-0002 in people with Inflammation and Rheumatoid Arthritis, run by Janssen Research & Development, LLC at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to 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?: NNC0142-0002
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 3 sitesin 3 countries
Study dates: Aug 2010to Apr 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product
Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to fifth)
Concomitant treatment with methotrexate (MTX) (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing
Ability to be examined by Magnetic Resonance Imaging (MRI)
Having failed no biologic therapies for RA and no more than two non-biologic disease modifying antirheumatic drugs

Who cannot join

Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)
Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to trial start
Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m^2

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Germany1 site

Study site
Berlin, 13353

Other trials in Germany

Russia1 site

Study site
Moscow, 109240

Other trials in Russia

Ukraine1 site

Study site
Kiev, 03680

Other trials in Ukraine

About this study

Official title: A Randomised, Single-dose, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0142-0002 in Subjects With Active Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis (RA).

Conditions: Inflammation, Rheumatoid Arthritis
Being tested: NNC0142-0002, 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.

NNC0142-0002Drug
A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).
placeboDrug
A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).

Study groups in NCT01181050
Study group	Role	What they receive
4.0 mg/kg	Experimental	Subjects received a single dose of 4 mg/kg NNC0142-0002 Receives: Drug: NNC0142-0002
Placebo	Placebo comparator	Subjects received a single dose of placebo Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in DAS28-CRP After 12 Weeks of Treatment
DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.
Measured: Week 0, Week 12

Secondary outcomes (2)

Change in DAS28-CRP After 6 Weeks of Treatment.
DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment.
Measured: Week 0, Week 6
Change in DAS28-CRP After 24 Weeks of Treatment.
DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment.
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.

Aug 2010Apr 2012

First posted13 Aug 2010 (estimated)
Study startAug 2010
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InflammationStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe 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: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01181050
Sponsor's protocol ID: NN8555-3796
Other IDs: U1111-1114-9194, 2010-019261-28
Status last verified: Aug 2016
First submitted: 12 Aug 2010
Last updated: 3 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Single-dose, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0142-0002 in Subjects With Active Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01181050
Acronym / sponsor ID: NN8555-3796
Conditions: Inflammation, Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 13 Aug 2010 (estimated)
Results: Posted 28 Apr 2014

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 clinical efficacy of a single dose of NNC0142-0002 administered to 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
4.0 mg/kg	Experimental	Drug: NNC0142-0002Subjects received a single dose of 4 mg/kg NNC0142-0002
Placebo	Placebo comparator	Drug: placeboSubjects received a single dose of 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)

A diagnosis of RA meeting the American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product
Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to fifth)
Concomitant treatment with methotrexate (MTX) (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing
Ability to be examined by Magnetic Resonance Imaging (MRI)
Having failed no biologic therapies for RA and no more than two non-biologic disease modifying antirheumatic drugs

Key exclusion criteria (3 listed)

Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)
Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to trial start
Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m^2

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
NNC0142-0002A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).	Drug	4.0 mg/kg
placeboA single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).	Drug	Placebo

Primary outcome

Change in DAS28-CRP After 12 Weeks of Treatment
Time frame: Week 0, Week 12
DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.

2 secondary outcomes

Change in DAS28-CRP After 6 Weeks of Treatment.
Time frame: Week 0, Week 6
Change in DAS28-CRP After 24 Weeks of Treatment.
Time frame: Week 0, Week 24

Results and safety

Results posted to the registry on 28 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
4.0 mg/kg	41	41
Placebo	22	22

Primary outcome: Change in DAS28-CRP After 12 Weeks of Treatment

Time frame: Week 0, Week 12. Mean (Standard Deviation). Unit: scores

Measure	4.0 mg/kg n = 41	Placebo n = 22
Value	-1.0 (1.0)	-1.0 (1.0)

4.0 mg/kg vs Placebo: Treatment difference: -0.02 (95% CI -0.54 to 0.50), p = 0.9334, Mixed effect model repeated measures

Population analysed: Change in DAS28-CRP was calculated by using last observation carried forward method.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected from dosing until end of trial (a total of 24 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
4.0 mg/kg	3 of 41 (7.3%)	5 of 41 (12.2%)	Not reported
Placebo	1 of 22 (4.5%)	5 of 22 (22.7%)	Not reported

Limitations and caveats (from the sponsor): As per protocol, this clinical proof-of-principle trial investigated a limited number of participants and doses (single-dose regimen).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNC0142-0002 in people with Inflammation and Rheumatoid Arthritis, run by Janssen Research & Development, LLC at 3 sites in 3 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 5 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 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Russia, Ukraine. 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?

Yes. Results are posted in the registry (first posted 28 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 After 12 Weeks of Treatment (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 NCT01181050.

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 3 Oct 2016.