NCT02758769Completed
Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
Source: ClinicalTrials.gov · Last updated 22 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 303 (actual)
- First submitted
- 14 Apr 2016
- Start date
- 7 Jun 2016
- Primary completion date
- 15 Nov 2023
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT02758769
What you commit to
- Study type: Observational
- Participants enrolled: 303
- From 7 Jun 2016 to the primary completion date, 15 Nov 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Past history of hypersensitivity to the components of the abatacept preparation
- Disease complications from a comorbidity
- Active infectious disease
Other
- Been judged by the investigator or the co-investigator as being inappropriate
- Other protocol defined inclusion/exclusion criteria could apply
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.