A Study of E6011 in Japanese Subjects With Rheumatoid Art... | NCT02196558

NCT02196558

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).	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).	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).	Drug: E6011

Name	Type	Description	Arm Group Labels	Other Names
E6011	Drug		E6011, 100 mg Arm E6011, 200 mg Arm E6011, 400 mg Arm

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Up to 52 Weeks

Measure	Description	Time Frame
Number of Participants With Positive Anti-E6011 Antibodies Results		Up to 52 weeks
Serum Concentrations of E6011		At Week 0 (predose), Week 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (postdose)

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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.
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.

Exclusion Criteria

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.
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.

PubMed Identifier	Type	Citation	Retractions
28681650	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	E6011: 100 mg	Participants received E6011 100 milligram (mg), subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
FG001	E6011: 200 mg	Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
FG002	E6011: 400 mg	Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).

Periods

Title

Milestones

Reasons Not Completed

Treatment Phase (12 Weeks)

Type	Comment	Milestone Data
STARTED		FG00012 subjects FG00115 subjects FG00210 subjects
COMPLETED		FG00012 subjects FG00112 subjects FG0028 subjects
NOT COMPLETED		FG0000 subjects FG0013 subjects FG0022 subjects

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0012 subjects FG0020 subjects
Participant Choice		FG000

Extension Phase (40 Weeks)

Type	Comment	Milestone Data
STARTED		FG00011 subjectsParticipants who wished to continue, had no safety issues, and had\>=20% improvement in joint counts. FG00111 subjectsParticipants who wished to continue, had no safety issues, and had\>=20% improvement in joint counts. FG0026 subjectsParticipants who wished to continue, had no safety issues, and had\>=20% improvement in joint counts.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	E6011: 100 mg	Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

The safety analysis set included group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Posted

Count of Participants

Participants

Up to 52 Weeks

ID	Title	Description
OG000	E6011: 100 mg	Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).
OG001	E6011: 200 mg

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	E6011: 100 mg	Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks [Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks]).

Facility	Status	City	State	ZIP	Country	Contacts
		Kitakyushu	Fukuoka		Japan

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases