Rheumatoid ArthritisPhase 3NCT01927263
A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis
A Phase 3 study testing NI-071 and Infliximab in people with Rheumatoid Arthritis, run by Nichi-Iko Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding to Methotrexate. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- NI-071 and Infliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2013to Mar 2016
- Phase
- Phase 3
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of RA as defined by the American College Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria (ACR/EULAR 2010)
- Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit
Who cannot join
- Patients with a following past History or concomitant diseases
- Other Connective tissue disorders which may interfere the efficacy assessment
- Chronic or recurrent infectious disease
- Demyelinating disease
- Congestive heart failure
- lymphoproliferative disorder or myelodysplastic syndrome
Show all 9Show fewer
- Malignancy
- Interstitial lung disease
- Patients with active or latent tuberculosis or history of tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis -A Double-blind, Active Drug-controlled Study and Long-term Study-
The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding to Methotrexate.
- Conditions
- Rheumatoid Arthritis
- Being tested
- NI-071, Infliximab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NI-071Biological
100mg/vial
InfliximabBiological
Also called Remicade
100mg/vial
| Study group | Role | What they receive |
|---|---|---|
| NI-071 | Experimental | Not described Receives: Biological: NI-071 |
| Infliximab | Active comparator | Not described Receives: Biological: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy : Changes in DAS28-ESR
Measured: week 0 to week 14
Secondary outcomes (4)
Efficacy : Changes in DAS28
Measured: week 0 to week 54
Efficacy : Changes in ACR20, 50, 70
Measured: week 0 to week 54
Efficacy : Changes in ACR core-set
Measured: week 0 to week 54
Safety : Long term safety (Adverse Events, Immunogenicity, etc.)
Measured: to 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nichi-Iko Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927263
- Sponsor's protocol ID
- NI071F1(EFC13464)
- Status last verified
- Apr 2016
- First submitted
- 9 Aug 2013
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis -A Double-blind, Active Drug-controlled Study and Long-term Study-
- ClinicalTrials.gov ID
- NCT01927263
- Acronym / sponsor ID
- NI071F1(EFC13464)
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Nichi-Iko Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Aug 2013 (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.
The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding 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 |
|---|---|---|
| NI-071 | Experimental | Biological: NI-071 |
| Infliximab | Active comparator | Biological: Infliximab |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a diagnosis of RA as defined by the American College Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria (ACR/EULAR 2010)
- Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit
Key exclusion criteria (9 listed)
- Patients with a following past History or concomitant diseases
- Patients with active or latent tuberculosis or history of tuberculosis
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 |
|---|---|---|
| NI-071100mg/vial | Biological | NI-071 |
| InfliximabAlso: Remicade100mg/vial | Biological | Infliximab |
Primary outcome
Efficacy : Changes in DAS28-ESR
Time frame: week 0 to week 14
4 secondary outcomes
Efficacy : Changes in DAS28
Time frame: week 0 to week 54
Efficacy : Changes in ACR20, 50, 70
Time frame: week 0 to week 54
Efficacy : Changes in ACR core-set
Time frame: week 0 to week 54
Safety : Long term safety (Adverse Events, Immunogenicity, etc.)
Time frame: to 54 weeks
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 8 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NI-071 and Infliximab in people with Rheumatoid Arthritis, run by Nichi-Iko Pharmaceutical Co., Ltd. at 1 site in Japan.
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 2 inclusion and 9 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 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy : Changes in DAS28-ESR (time frame: week 0 to week 14). 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 8 Apr 2016.