Abatacept Post-marketing Clinical Study in Japan

NCT01758198 | Completed Phase 4

• 1 other identifier: IM101-338
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 74

Brief Summary

The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• American College of Rheumatology (ACR) 20% response rate

  4 months (week 16)

• Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)

  Baseline (Day 1), 6 months (Week 24)

Secondary Outcomes (5)

• Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)

  Baseline (Day 1), 4 months (Week 16)

• Non-progressors rate for the structural damage

  Baseline (Day 1), 6 months (Week 24)

• ACR 50 response rates

  4 months (Week16)

• ACR 70 response rates

  4 months (Week16)

• Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities

  12 months (Week52)

Study Arms (2)

Group 1: Abatacept + Methotrexate (MTX)

EXPERIMENTAL

Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months Methotrexate ≥6 mg/week for 12 months

Biological: Abatacept; Drug: Methotrexate

Group 2: Placebo matching with Abatacept + Methotrexate

PLACEBO COMPARATOR

Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months Methotrexate ≥6 mg/week for 12 months

Drug: Placebo matching with Abatacept; Drug: Methotrexate

Interventions

Abatacept BIOLOGICAL

Also known as: BMS-188667 (Orencia)

Group 1: Abatacept + Methotrexate (MTX)

Placebo matching with Abatacept DRUG

Group 2: Placebo matching with Abatacept + Methotrexate

Methotrexate DRUG

Group 1: Abatacept + Methotrexate (MTX); Group 2: Placebo matching with Abatacept + Methotrexate

Eligibility Criteria

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

You may qualify if:

• MTX inadequate responder
• Biologic Naïve
• Functional class I, II or III
• ≥6 swollen and ≥6 tender joints
• C-reactive protein (CRP) ≥2.0mg/dl or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
• Anti-cyclic citrullinated peptide (CCP) antibody positive
• Have erosion

You may not qualify if:

• Any other rheumatic disease
• Active angiitis on main organs excluding rheumatoid nodule

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (74)

Local Institution

Kamogawa, Chiba, 296-8602, Japan

Location

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Kasamatsu-town, Gifu, 501-6061, Japan

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Kakogawa, Hyōgo, 675-8611, Japan

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Yokohama, Kanagawa, 245-8575, Japan

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Kurashiki, Okayama-ken, 710-8602, Japan

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Izumisano, Osaka, 598-0048, Japan

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Fujieda, Shizuoka, 426-8677, Japan

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Toyama, Toyama, 930-8550, Japan

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Shimonoseki, Yamaguchi, 750-8520, Japan

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Asahi, 289-2511, Japan

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Fuchū, 183-8524, Japan

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Fukuoka, 810-8563, Japan

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Fukuoka, 813-0017, Japan

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Funabashi, 274-0053, Japan

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Hakodate, 040-8611, Japan

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Hiroshima, 734-8551, Japan

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Hitachi, 316-0015, Japan

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Hokkaido, 078-8243, Japan

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Iizuka, 820-8505, Japan

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Kagoshima, 890-0067, Japan

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Kagoshima, 891-0133, Japan

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Kanazawa, 920-8616, Japan

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Kasama, 309-1793, Japan

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Katō, 673-1462, Japan

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Kitakyushu, 800-0031, Japan

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Kitakyushu, 800-0296, Japan

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Kitakyushu, 807-8556, Japan

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Kitamoto, 364-8501, Japan

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Kobe, 650-0017, Japan

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Kobe, 654-0047, Japan

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Kochi, 781-0112, Japan

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Kōshi, 861-1196, Japan

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Kumamoto, 862-0976, Japan

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Matsumoto, 390-8601, Japan

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Nagano, 380-8582, Japan

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Nagaoka, 940-2085, Japan

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Nagasaki, 850-0832, Japan

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Nagoya, 460-0001, Japan

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Nagoya, 466-8560, Japan

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Narashino, 275-0006, Japan

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Narita, 286-0041, Japan

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Okayama, 700-8607, Japan

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Osaka, 545-8585, Japan

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Ōme, 198-0042, Japan

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Ōsaki, 989-6183, Japan

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Sapporo, 001-0907, Japan

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Sapporo, 060-0001, Japan

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Sapporo, 060-8648, Japan

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Sapporo, 063-0811, Japan

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Sasebo, 857-1195, Japan

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Sayama, 350-1305, Japan

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Sendai, 980-6116, Japan

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Sendai, 982-0032, Japan

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Sendai, 983-8512, Japan

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Shizuoka, 420-0821, Japan

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Takaoka, 933-0874, Japan

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Takasaki, 370-0053, Japan

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Tokyo, 101-0062, Japan

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Tokyo, 104-8560, Japan

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Tokyo, 130-8575, Japan

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Tokyo, 160-8582, Japan

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Tokyo, 162-8543, Japan

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Tokyo, 162-8655, Japan

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Tokyo, 170-8476, Japan

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Tokyo, 173-8610, Japan

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Tokyo, 174-0071, Japan

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Tokyo, 179-0072, Japan

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Tomakomai, 053-0018, Japan

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Toyama, 930-0138, Japan

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Toyama, 930-0194, Japan

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Utsunomiya, 321-0964, Japan

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Yokohama, 231-8682, Japan

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Yokohama, 236-0004, Japan

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Yotsukaidō, 284-0003, Japan

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept; Methotrexate

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; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: January 1, 2013
• Study Start: April 11, 2013
• Primary Completion: December 26, 2016
• Study Completion: December 26, 2016
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

JP (74)