Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 137 for:    "Connective Tissue Disease" | "Abatacept"

Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02758769
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Biological: ORENCIA Subcutaneous Injection

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
Actual Study Start Date : November 30, 2015
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
ORENCIA with Exposure
ORENCIA with Exposure
Biological: ORENCIA Subcutaneous Injection
Other Name: Abatacept




Primary Outcome Measures :
  1. Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept [ Time Frame: 52 Weeks ]

Secondary Outcome Measures :
  1. Percentage of achievement in low disease activity by simplified disease activity index (SDAI). [ Time Frame: 52 Weeks ]
  2. Change in the percentage of disease activity category by simplified disease activity index(SDAI) [ Time Frame: 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 ]
  3. Change in the percentage of disease activity category by clinical disease activity index(CDAI) [ Time Frame: 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 ]
  4. Change in the percentage of disease activity category by disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR) [ Time Frame: 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 ]
  5. Change in the percentage of disease activity category by disease activity score with 28 joint counts creactive protein (DAS28-CRP) [ Time Frame: 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 ]
  6. Change in simplified disease activity index(SDAI) [ Time Frame: 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 ]
  7. Change in clinical disease activity index(CDAI) [ Time Frame: 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 ]
  8. Change in disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR) [ Time Frame: 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 ]
  9. Change in disease activity score with 28 joint counts Creactive protein (DAS28-CRP) [ Time Frame: 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 ]
  10. Change in Anti-citrullinated protein antibodies (ACPA) [ Time Frame: 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 ]
  11. Change in Rheumatoid factors (RF) [ Time Frame: 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 ]
  12. Survival rate [ Time Frame: 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 ]
  13. Hospitalization rate [ Time Frame: 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 ]
  14. Number of occurrences of rheumatoid arthritis related surgery [ Time Frame: 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 ]
  15. Persistence rate of Abatacept treatment [ Time Frame: 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. Reasons for discontinuation of Abatacept treatment [ Time Frame: 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 ]
  17. Change in Japanese Health Assessment Questionnaire [ Time Frame: 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 ]
  18. Change in European Quality of Life 5 Dimension Questionnaire [ Time Frame: 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 ]
  19. Change in Pain visual analog scale [ Time Frame: 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 ]
  20. Change in General visual analog scale [ Time Frame: 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 ]
  21. Change in PRO parameters defined in IORRA registry (JMAJ 2009 52 (1) 54-56) [ Time Frame: 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 ]

Biospecimen Retention:   Samples Without DNA
Whole Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Clinic
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758769


Contacts
Layout table for location contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
Layout table for location information
Japan
Local Institution Recruiting
Minato-ku, Tokyo, Japan, 1070052
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02758769     History of Changes
Other Study ID Numbers: IM101-574
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Connective Tissue Diseases
Abatacept
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents