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Clinical Trials List

Protocol NumberIM101-550
NCT Number(ClinicalTrials.gov Identfier)NCT02504268

2015-11-01 - 2020-02-17

Phase III

Terminated4

ICD-10M06.9

Rheumatoid arthritis, unspecified

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chang-Youh Tsai Division of Rheumatology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Chia-Tse Weng 風濕免疫科
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Chang-Fu Kuo Division of Rheumatology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

7 Completed

Audit

None

Principal Investigator SONG-CHOU HSIEH Division of Rheumatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Rheumatoid Arthritis

Objectives

The primary objective for this study is to compare the clinical efficacy of weekly abatacept in combination with MTX to MTX alone in achieving Remission, defined as SDAI  3, at Week 24.

Test Drug

Abatacept

Active Ingredient

Abatacept

Dosage Form

subcutaneous injection

Dosage

125 mg/syringe (125 mg/mL)

Endpoints

The primary efficacy endpoint is the proportion of subjects in SDAI Remission at Week 24.
The secondary endpoints below will be assessed in the order below in a hierarchical fashion after the primary
endpoint is met to preserve the type I error of the study at 5%
(1) Proportion of subjects in DA28-CRP Remission at Week 24
(2) Proportion of subjects in SDAI Remission at Week 52
(3) Mean change from baseline in TSS at Week 52
(4) Proportion of subjects in Boolean Remission at Week 52

Inclution Criteria

Key Inclusion criteria: Target population
a) Subjects have early RA, defined as diagnosis made by the ACR/EULAR 2010 criteria for the classification
of RA within the past 6 months
b) Subjects must meet at least one of the following criteria:
i) CRP > 0.3mg/dL (ULN)
ii) ESR  28mm/hr
c) Subjects have at least 3 tender joints and at least 3 swollen joints using the 28 Joint Count Assessment at
both screening and Day 1 (Appendix 11)
d) Subjects are positive for anti-citrullinated protein antibodies (ACPA)

Exclusion Criteria

Key Exclusion criteria: Medical history and concurrent diseases
a) Subjects at risk for tuberculosis
b) Subjects with recent acute infection
c) Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections.
d) Subjects who have present or previous malignancies, except documented history of cured non-metastatic
squamous or basal skin cell carcinoma, or cervical carcinoma in situ

The Estimated Number of Participants

  • Taiwan

    1000 participants

  • Global

    20 participants

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