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Trial record 60 of 1224 for:    arthritis+management

A Phase 1/2 Study of E6011 in Japanese Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02196558
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief 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 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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: E6011 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Repeated Subcutaneous E6011 Administration in Japanese Subjects With Rheumatoid Arthritis
Actual Study Start Date : June 9, 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : July 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: E6011, 100 mg Arm
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
Experimental: E6011, 200 mg Arm
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
Experimental: E6011, 400 mg Arm
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



Primary Outcome Measures :
  1. Safety and tolerability as a measure of Adverse Events/ Serious Adverse events [ Time Frame: up to 52 weeks plus 28 days from study completion ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve (AUC) of drug E6011 [ Time Frame: Day 1, 2, 4, 6, 8, 10, 12, followed by every 4 weeks post dose up to 52 weeks ]
  2. Immunogenicity of E6011: Serum anti-E6011 antibody [ Time Frame: Day 2, 4, 8, 12, followed by every 4 weeks post dose up to 52 weeks ]
  3. Cmax of drug E6011 [ Time Frame: Day 1, 2, 4, 6, 8, 10, 12, followed by every 4 weeks post dose up to 52 weeks ]
  4. Half life (T1/2) of drug E6011 [ Time Frame: Day 1, 2, 4, 6, 8, 10, 12, followed by every 4 weeks post dose up to 52 weeks ]
  5. Time to Cmax (Tmax) of drug E6011 [ Time Frame: Day 1, 2, 4, 6, 8, 10, 12, followed by every 4 weeks post dose up to 52 weeks ]


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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Subjects must meet all of the following criteria to be included in this study:

  1. Japanese patients aged 20 to 64 years old at the time of informed consent.
  2. Diagnosed with rheumatoid arthritis (RA) who meet the 1987 ACR or 2010 ACR/EULAR criteria.
  3. 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.
  4. Never been treated with non-anti-TNF biologics or never been treated with 2 or more anti-TNF agents.
  5. 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.
  6. Weighs greater than or equal to 30 kg and less than or equal to 100 kg at Screening.
  7. 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.
  8. Has voluntarily consented, in writing, to participate in this study
  9. 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:

  1. Any history or complication of inflammatory arthritic disorder other than rheumatoid arthritis or Sjogren's syndrome.
  2. Meet Class 4 with the Steinbrocker functional classification.
  3. History or current clinical condition, or associated complications of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease.
  4. Immunodeficiency or history of HIV infection
  5. 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.
  6. History of tuberculosis or current complication of active tuberculosis.
  7. History of severe allergy (shock, or anaphylactoid symptoms).
  8. History of clinically important vascular edema, hematemesis, hemorrhagic stool, or hemoptysis.
  9. History of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterans.
  10. History of clinically important vasculitis (such as mononeuritis multiplex).
  11. 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.
  12. Any result other than negative in tuberculosis test (T-SPOT.TB Test or QuantiFERON TB Gold Test) at Screening.
  13. Findings indicating a history of tuberculosis on chest X-ray at Screening.
  14. Ineligible to participate in the study in the opinion of the investigator or sub investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196558


Locations
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Japan
Kitakyushu, Fukuoka, Japan
Sapporo, Hokkaido, Japan
Kakogawa, Hyogo, Japan
Kato, Hyogo, Japan
Kahoku-gun, Ishikawa, Japan
Yokohama, Kanagawa, Japan
Hamamatsu, Shizuoka, Japan
Chuo-Ku, Tokyo, Japan
Meguro-Ku, Tokyo, Japan
Ota-Ku, Tokyo, Japan
Shinjuku-Ku, Tokyo, Japan
Miyazaki, Japan
Sponsors and Collaborators
Eisai Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02196558     History of Changes
Other Study ID Numbers: E6011-J081-103
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Rheumatoid Arthritis
Japanese subjects

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
E6011
Antirheumatic Agents