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Completed

NCT Number: NCT01758198

Abatacept Post-marketing Clinical Study in Japan

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution, Kamogawa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Abatacept

Biological

Other names: BMS-188667 (Orencia)

Placebo matching with Abatacept

Drug

methotrexate

Drug

Primary outcomes

  1. American College of Rheumatology (ACR) 20% response rate

    Time frame: 4 months (week 16)

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

    Time frame: Baseline (Day 1), 6 months (Week 24)

Secondary outcomes

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

    Time frame: Baseline (Day 1), 4 months (Week 16)

  2. Non-progressors rate for the structural damage

    Time frame: Baseline (Day 1), 6 months (Week 24)

    The non-progressors rate is defined as the proportion of subjects meeting the change from baseline in the TSS at 6 months less than or equal to the smallest detectable difference (SDD) and/or the smallest detectable change (SDC)

  3. ACR 50 response rates

    Time frame: 4 months (Week16)

  4. ACR 70 response rates

    Time frame: 4 months (Week16)

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

    Time frame: 12 months (Week52)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2013
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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