Arthritis, RheumatoidPhase 1/2NCT02196558
A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis
A Phase 1/2 study testing E6011 in people with Arthritis, Rheumatoid, run by Eisai Co., Ltd. at 12 sites in Japan.
Trial summary
This study consist of treatment phase (12 weeks) and extension phase (40 weeks). This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated subcutaneous administration of E6011 in Japanese subjects with Rheumatoid… Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- E6011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 12 sitesJapan
- Study dates
- 26 May 2014to 13 Jul 2017
- Phase
- Phase 1/2
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in this study:
- Japanese patients aged 20 to 64 years old at the time of informed consent.
- Diagnosed with rheumatoid arthritis (RA) who meet the 1987 ACR or 2010 ACR/EULAR criteria.
- Presenting tenderness in more than 4 joints (out of 68) and swelling in more than 4 joints (out of 66) at Screening and Observation phase.
- Never been treated with non-anti-TNF biologics or never been treated with 2 or more anti-TNF agents.
- Subjects with greater than or equal to 0.6 mg/dL of high-sensitivity CRP (hs-CRP) level or greater than or equal to 28 mm/hr of erythrocyte sedimentation rate (ESR) at Screening.
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- Weighs greater than or equal to 30 kg and less than or equal to 100 kg at Screening.
- Consent to use contraception (both the subject and the subject's partner), for at least 70 days after the last dose of study medication starting on the day of informed consent, if the subject is a man capable of reproduction or a woman of childbearing potential.
- Has voluntarily consented, in writing, to participate in this study
- Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with all aspects of the protocol.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Any history or complication of inflammatory arthritic disorder other than rheumatoid arthritis or Sjogren's syndrome.
- Meet Class 4 with the Steinbrocker functional classification.
- History or current clinical condition, or associated complications of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease.
- Immunodeficiency or history of HIV infection
- Infection requiring hospitalization or intravenous administration of antibiotics within 4 weeks before the first dose of study treatment, or an infection requiring oral antibiotics within 2 weeks before the first dose of study treatment.
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- History of tuberculosis or current complication of active tuberculosis.
- History of severe allergy (shock, or anaphylactoid symptoms).
- History of clinically important vascular edema, hematemesis, hemorrhagic stool, or hemoptysis.
- History of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterans.
- History of clinically important vasculitis (such as mononeuritis multiplex).
- Tested positive for any of the following at Screening: human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus core antibody (HBc antibody), hepatitis B virus DNA (HBV DNA), hepatitis C virus antibody (HCV antibody), human T-lymphotrophic virus Type I antibody (HTLV-1 antibody), or syphilis.
- Any result other than negative in tuberculosis test (T-SPOT.TB Test or QuantiFERON TB Gold Test) at Screening.
- Findings indicating a history of tuberculosis on chest X-ray at Screening.
- Ineligible to participate in the study in the opinion of the investigator or sub investigator.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Study site
Chuo-Ku, Tokyo
Study site
Hamamatsu, Shizuoka
Study site
Kahoku-gun, Ishikawa-ken
Study site
Kakogawa, Hyōgo
Study site
Katō, Hyōgo
Study site
Kitakyushu, Fukuoka
Study site
Meguro-Ku, Tokyo
Study site
Miyazaki
Study site
Ōta-ku, Tokyo
Study site
Sapporo, Hokkaido
Study site
Shinjuku-Ku, Tokyo
Study site
Yokohama, Kanagawa
About this study
Official title: A Phase 1/2 Study of Repeated Subcutaneous E6011 Administration in Japanese Subjects With Rheumatoid Arthritis
This study consist of treatment phase (12 weeks) and extension phase (40 weeks). This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated subcutaneous administration of E6011 in Japanese subjects with Rheumatoid Arthritis. First 12 subjects will enroll as 100 mg group, next 12 subjects will enroll as 200 mg group, and last 9 subjects will enroll as 400 mg group. A total of 33 subjects will receive repeated subcutaneous administration of E6011. Subjects who roll over onto the Extension phase will have continued monitoring until 52 weeks after the initial administration.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- E6011
- Keywords
- Rheumatoid Arthritis, Japanese subjects
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6011Drug
| Study group | Role | What they receive |
|---|---|---|
| E6011, 100 mg Arm | Experimental | E6011 will be administered repeatedly, subcutaneously at Week 0, 1, 2, followed by every 2 weeks upto 10 weeks (treatment phase).100 mg group will receive E6011 subcutaneously, 1 ml. If a subject intends to continue administrations; the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension phase). Receives: Drug: E6011 |
| E6011, 200 mg Arm | Experimental | E6011 will be administered repeatedly, subcutaneously at Week 0, 1, 2, followed by every 2 weeks upto 10 weeks (treatment phase). 200 mg group will receive E6011 subcutaneously, 1 ml each at two sites. If a subject intends to continue administrations; the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension phase). Receives: Drug: E6011 |
| E6011, 400 mg Arm | Experimental | E6011 will be administered repeatedly, subcutaneously at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks (treatment phase). 400 mg group will receive E6011 subcutaneously, 1 ml each at four sites or 2 ml each at two sites. If a subject intends to continue administrations, the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension Phase). Receives: Drug: E6011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to 52 Weeks
Secondary outcomes (2)
Number of Participants With Positive Anti-E6011 Antibodies Results
Measured: Up to 52 weeks
Serum Concentrations of E6011
Measured: At Week 0 (predose), Week 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study start26 May 2014
- Primary completion12 Aug 2016
- Study completion13 Jul 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196558
- Sponsor's protocol ID
- E6011-J081-103
- Status last verified
- Aug 2017
- First submitted
- 16 Jul 2014
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tanaka Y, Takeuchi T, Umehara H, Nanki T, Yasuda N, Tago F, Kawakubo M, Kitahara Y, Hojo S, Kawano T, Imai T. Safety, pharmacokinetics, and efficacy of E6011, an antifractalkine monoclonal antibody, in a first-in-patient phase 1/2 study on rheumatoid arthritis. Mod Rheumatol. 2018 Jan;28(1):58-65. doi: 10.1080/14397595.2017.1337056. Epub 2017 Jul 6.
PubMed 28681650
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Repeated Subcutaneous E6011 Administration in Japanese Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02196558
- Acronym / sponsor ID
- E6011-J081-103
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, Japanese subjects
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 May 2014 (actual)
- Primary completion
- 12 Aug 2016 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study consist of treatment phase (12 weeks) and extension phase (40 weeks). This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated subcutaneous administration of E6011 in Japanese subjects with Rheumatoid Arthritis. First 12 subjects will enroll as 100 mg group, next 12 subjects will enroll as 200 mg group, and last 9 subjects will enroll as 400 mg group. A total of 33 subjects will receive repeated subcutaneous administration of E6011. Subjects who roll over onto the Extension phase will have continued monitoring until 52 weeks after the initial administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| E6011, 100 mg Arm | Experimental | Drug: E6011E6011 will be administered repeatedly, subcutaneously at Week 0, 1, 2, followed by every 2 weeks upto 10 weeks (treatment phase).100 mg group will receive E6011 subcutaneously, 1 ml. If a subject intends to continue administrations; the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension phase). |
| E6011, 200 mg Arm | Experimental | Drug: E6011E6011 will be administered repeatedly, subcutaneously at Week 0, 1, 2, followed by every 2 weeks upto 10 weeks (treatment phase). 200 mg group will receive E6011 subcutaneously, 1 ml each at two sites. If a subject intends to continue administrations; the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension phase). |
| E6011, 400 mg Arm | Experimental | Drug: E6011E6011 will be administered repeatedly, subcutaneously at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks (treatment phase). 400 mg group will receive E6011 subcutaneously, 1 ml each at four sites or 2 ml each at two sites. If a subject intends to continue administrations, the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension Phase). |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Japanese patients aged 20 to 64 years old at the time of informed consent.
- Diagnosed with rheumatoid arthritis (RA) who meet the 1987 ACR or 2010 ACR/EULAR criteria.
- Presenting tenderness in more than 4 joints (out of 68) and swelling in more than 4 joints (out of 66) at Screening and Observation phase.
- Never been treated with non-anti-TNF biologics or never been treated with 2 or more anti-TNF agents.
- Subjects with greater than or equal to 0.6 mg/dL of high-sensitivity CRP (hs-CRP) level or greater than or equal to 28 mm/hr of erythrocyte sedimentation rate (ESR) at Screening.
Key exclusion criteria (15 listed)
- Any history or complication of inflammatory arthritic disorder other than rheumatoid arthritis or Sjogren's syndrome.
- Meet Class 4 with the Steinbrocker functional classification.
- History or current clinical condition, or associated complications of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease.
- Immunodeficiency or history of HIV infection
- Infection requiring hospitalization or intravenous administration of antibiotics within 4 weeks before the first dose of study treatment, or an infection requiring oral antibiotics within 2 weeks before the first dose of study treatment.
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 |
|---|---|---|
| E6011 | Drug | E6011, 100 mg Arm, E6011, 200 mg Arm, E6011, 400 mg Arm |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 52 Weeks
2 secondary outcomes
Number of Participants With Positive Anti-E6011 Antibodies Results
Time frame: Up to 52 weeks
Serum Concentrations of E6011
Time frame: At Week 0 (predose), Week 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (postdose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28681650Tanaka Y, Takeuchi T, Umehara H, Nanki T, Yasuda N, Tago F, Kawakubo M, Kitahara Y, Hojo S, Kawano T, Imai T. Safety, pharmacokinetics, and efficacy of E6011, an antifractalkine monoclonal antibody, in a first-in-patient phase 1/2 study on rheumatoid arthritis. Mod Rheumatol. 2018 Jan;28(1):58-65. doi: 10.1080/14397595.2017.1337056. Epub 2017 Jul 6.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing E6011 in people with Arthritis, Rheumatoid, run by Eisai Co., Ltd. at 12 sites 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 10 inclusion and 15 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 combined 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.
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 13 Aug 2020). 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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to 52 Weeks). 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 NCT02196558, 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 13 Aug 2020.