A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

NCT00484289 | Completed Phase 3 Results

• 1 other identifier: IM101-129
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 39

Brief Summary

The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071, IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX intolerance.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs

  AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included.

  From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).

• Number of Participants With Abnormal Laboratory Changes (ALC)

  The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations.

  From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).

• Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator

  At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).

Secondary Outcomes (22)

• Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time

  At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.

• Percentage of Participants With ACR 50 Response Over Time

  At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.

• Percentage of Participants With ACR 70 Response Over Time

  At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.

• Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)

  At BL (week 0), week 24, 48, 96, 144, and 192.

• Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192

  At BL (week 0), weeks 24, 48, 96, 144, and 192.

Study Arms (3)

Arm 1: Participants from Phase I study (IM101-034)

EXPERIMENTAL

Drug: Abatacept

Arm 2: Participants from Phase II study (IM101-071)

EXPERIMENTAL

Drug: Abatacept

Arm 3: New Participants with Methotrexate (MTX) Intolerance

EXPERIMENTAL

Drug: Abatacept

Interventions

Abatacept DRUG

Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants \> 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.

Also known as: Orencia®, BMS-188667

Arm 1: Participants from Phase I study (IM101-034); Arm 2: Participants from Phase II study (IM101-071); Arm 3: New Participants with Methotrexate (MTX) Intolerance

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants who completed the 169 days, full study period of Phase II (IM101-071) and were not administered other biologics between completion of IM101-071 and registration of this long-term study.
• The participants of the Phase I study (IM101-034), who received abatacept, except participants who were withdrawn from the study due to safety problems related to abatacept.
• New subjects with MTX intolerance: rheumatoid arthritis (RA) patients to whom MTX cannot be administered for safety reasons and who present an inadequate response to disease-modifying antirheumatic drugs (DMARDs;excluding MTX) or biologics (new subjects with MTX intolerance: RA patients who present an inadequate response to DMARDs).

You may not qualify if:

• Women of childbearing potential (WOCBP) who were unwilling or unable to use an acceptable method of contraception.
• Participants who have received non approved or investigational biologics (other than abatacept from previous or ongoing studies in Japan) at registration.
• Participants who have received treatment with any investigational drug within 56 days before registration or five half-lives (whichever is the longest).
• Participants currently receiving treatment with leflunomide, mycophenolate mofetil, calcineurine inhibitors such as cyclosporine and tacrolimus, D-Penicillamine, Cyclophosphamide, or immunoadsorption columns.
• The participants who completed Phase II (IM101-071) are not applicable in the following instances at time of registration: with active vasculitis, symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of cancer within the last 5 years, evidence of active or latent bacterial , viral infections, any serious or chronic, at risk of tuberculosis (TB), with any opportunistic infections, laboratory values of hemoglobin \< 8.5 g/dL, white blood cells (WBC) \< 3,000/mm\^3, Platelets \< 100,000/mm\^3, Serum creatinine \> 2 times upper limit of normal (ULN), Serum alanine transaminase or aspartate aminotransferase \> 2 times ULN.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (39)

Local Institution

Nagoya, Aichi-ken, 460-0001, Japan

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Nagoya, Aichi-ken, 466-8550, Japan

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Goshogawara-Shi, Aomori, 037-0053, Japan

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Chiba, Chiba, Japan

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Fukui-shi, Fukui, 910-0041, Japan

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Fukui-shi, Fukui, 9100067, Japan

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Fukui-shi, Fukui, 9103133, Japan

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Fukuoka, Fukuoka, 810-0065, Japan

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Fukuoka, Fukuoka, 812-0025, Japan

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Kitakyushu-Shi, Fukuoka, 807-8555, Japan

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Higashi-Hiroshima-Shi, Hiroshima, 739-0002, Japan

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Sapporo, Hokkaido, 060-0001, Japan

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Sapporo, Hokkaido, 060-8604, Japan

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Sapporo, Hokkaido, 060-8648, Japan

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Kanzaki-Gun, Hyōgo, 679-2414, Japan

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Kato-Gun, Hyōgo, 673-1462, Japan

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Hitachi-Shi, Ibaraki, 316-0035, Japan

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Tsukuba, Ibaraki, 305-0005, Japan

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Sagamihara-Shi, Kanagawa, 228-8522, Japan

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Sendai, Miyagi, 981-0911, Japan

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Sendai, Miyagi, 982-0032, Japan

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Sendai, Miyagi, Japan

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Nagano, Nagano, 380-8582, Japan

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Tsukubo-Gun, Okayama-ken, 701-0304, Japan

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Kawachinagano-Shi, Osaka, 86-0008, Japan

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Ureshino-Shi, Saga-ken, 843-0301, Japan

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Iruma-Gun, Saitama, 350-0495, Japan

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Kawagoe-Shi, Saitama, 350-8550, Japan

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Kitamoto-Shi, Saitama, 364-0026, Japan

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Hamamatsu, Shizuoka, 430-0906, Japan

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Kawachigun, Tochigi, 329-1104, Japan

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Shimotsuke-Shi, Tochigi, 3290498, Japan

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Arakawa-Ku, Tokyo, 116-0011, Japan

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Bunkyo-Ku, Tokyo, 113-0022, Japan

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Bunkyo-Ku, Tokyo, 113-8519, Japan

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Setagaya-Ku, Tokyo, 155-0032, Japan

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Shinjuku-Ku, Tokyo, 162-0054, Japan

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Takaoka-Shi, Toyama, 933-8525, Japan

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Chiba, 260-0801, Japan

Location

Related Publications (1)

• Takeuchi T, Matsubara T, Urata Y, Suematsu E, Ohta S, Honjo S, Abe T, Yamamoto A, Miyasaka N; Japan Abatacept Study Group. Phase III, multicenter, open-label, long-term study of the safety of abatacept in Japanese patients with rheumatoid arthritis and an inadequate response to conventional or biologic disease-modifying antirheumatic drugs. Mod Rheumatol. 2014 Sep;24(5):744-53. doi: 10.3109/14397595.2014.899179. Epub 2014 Apr 23.

  PMID: 24754273 DERIVED

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 8, 2007
• Study Start: December 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 24, 2013
• Results First Posted: August 9, 2012

Record last verified: 2013-06

Locations

JP (39)