NCT02758769

Brief Summary

The purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 7, 2016

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

7.4 years

First QC Date

April 14, 2016

Last Update Submit

June 20, 2025

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept

    52 Weeks

Secondary Outcomes (21)

  • Percentage of achievement in low disease activity by simplified disease activity index (SDAI).

    52 Weeks

  • Change in the percentage of disease activity category by simplified disease activity index(SDAI)

    0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months

  • Change in the percentage of disease activity category by clinical disease activity index(CDAI)

    0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months

  • Change in the percentage of disease activity category by disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)

    0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months

  • Change in the percentage of disease activity category by disease activity score with 28 joint counts creactive protein (DAS28-CRP)

    0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months

  • +16 more secondary outcomes

Study Arms (1)

ORENCIA with Exposure

ORENCIA with Exposure

Biological: ORENCIA Subcutaneous Injection

Interventions

ORENCIA Subcutaneous InjectionBIOLOGICAL
Also known as: Abatacept
ORENCIA with Exposure

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • Patients with RA who meet the 2010 American College of Rheumatology / European League against Rheumatisms (ACR/EULAR) RA Classification Criteria
  • Patients with RA with a moderate disease activity (SDAI: \> 11 and 26)
  • Biologic-naive patients with treatment history csDMARDs
  • Patients who meet the following criteria by hematological examination:
  • Peripheral white blood cell count: 4,000/mm3
  • Peripheral lymphocyte count: 1,000/mm3
  • Blood β-D-glucan negative
  • Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study
  • Patients initiated with abatacept at per their physician's therapeutic decision

You may not qualify if:

  • Past history of hypersensitivity to the components of the abatacept preparation
  • Disease complications from a comorbidity
  • Active infectious disease
  • Been judged by the investigator or the co-investigator as being inappropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution - 0001

Minato-ku, Tokyo, 1070052, Japan

Location

Local Institution

Minato-ku, Tokyo, 1070052, Japan

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2016

First Posted

May 2, 2016

Study Start

June 7, 2016

Primary Completion

November 15, 2023

Study Completion

November 15, 2023

Last Updated

June 22, 2025

Record last verified: 2025-06

Locations

JP(2)