Rheumatoid ArthritisPhase 1NCT01567358
Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis
A Phase 1 study testing 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 compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with 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?
- Infliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2012to Apr 2013
- Phase
- Phase 1
- 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
- Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months
- Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit
Who cannot join
- History of following diseases
- Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment
- Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.）
- Severe infectious disease（hepatitis, pneumonia、sepsis）
- History of demyelinating disease or multiple sclerosis
- Congestive heart failure
Show all 10Show fewer
- lymphoproliferative disorder or myelodysplastic syndrome
- History of 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 Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate
The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with Methotrexate.
- Conditions
- Rheumatoid Arthritis
- Being tested
- 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.
InfliximabBiological
100mg/vial
InfliximabBiological
100mg/vial
| Study group | Role | What they receive |
|---|---|---|
| NI-071 | Experimental | Not described Receives: Biological: Infliximab |
| Remicade | Active comparator | Not described Receives: Biological: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety : Incidence of Adverse Events
Measured: 14 weeks
Secondary outcomes (2)
PK : Area under the serum concentration versus time curve(AUC)
Measured: 14 weeks
Efficacy : ACR core-set
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionApr 2013
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 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
- NCT01567358
- Sponsor's protocol ID
- NI071C1(ACT12719)
- Status last verified
- Jun 2013
- First submitted
- 23 Mar 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate
- ClinicalTrials.gov ID
- NCT01567358
- Acronym / sponsor ID
- NI071C1(ACT12719)
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nichi-Iko Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Mar 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.
The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with 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: Infliximab |
| Remicade | 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)
- Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months
- Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit
Key exclusion criteria (10 listed)
- History of following 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 |
|---|---|---|
| Infliximab100mg/vial | Biological | NI-071 |
| Infliximab100mg/vial | Biological | Remicade |
Primary outcome
Safety : Incidence of Adverse Events
Time frame: 14 weeks
2 secondary outcomes
PK : Area under the serum concentration versus time curve(AUC)
Time frame: 14 weeks
Efficacy : ACR core-set
Time frame: 14 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 19 Jun 2013.
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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 1 study testing 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 10 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 19 Jun 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety : Incidence of Adverse Events (time frame: 14 weeks). 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 19 Jun 2013; AzTrials last refreshed its copy on 7 Nov 2026.