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A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis (ASCEND)

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ClinicalTrials.gov Identifier: NCT03457792
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Abatacept

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : March 12, 2021
Estimated Study Completion Date : March 12, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
Abatacept for Rheumatoid Arthritis (RA)
Participants diagnosed with moderate to severe active RA within the last 24 months and initiated treatment with Abatacept
Drug: Abatacept
Subcutaneous (SC) or intravenous (IV) administration
Other Names:
  • Orencia
  • BMS-188667




Primary Outcome Measures :
  1. Number of patients continuing with abatacept treatment [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Anti-citrullinated protein antibody (ACPA) titer [ Time Frame: At baseline ]
  2. Concomitant treatment given with abatacept as determined by the investigator [ Time Frame: Up to 12 months ]
  3. Dosage of abatacept as determined by the investigator [ Time Frame: Up to 12 months ]
  4. Frequency of administration of abatacept [ Time Frame: Up to 12 months ]
  5. Reason for abatacept treatment initiation as determined by the investigator [ Time Frame: At baseline ]
  6. Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD) [ Time Frame: Up to 12 months ]
  7. Socio-demographics of participants as determined by the investigator [ Time Frame: At baseline ]
  8. Disease history of participants as determined by the investigator [ Time Frame: At baseline ]
  9. Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia) [ Time Frame: Up to 12 months ]
  10. Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency) [ Time Frame: Up to 12 months ]
  11. Simplified Disease Activity Score (based on 28 joints) (DAS28) [ Time Frame: Up to 12 months ]
    DAS28: Swollen joint count [SJC], tender joint count [TJC], C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]

  12. Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria [ Time Frame: Up to 12 months ]
  13. Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2) [ Time Frame: Up to 12 months ]
  14. Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2 [ Time Frame: Up to 12 months ]
  15. Number of patients who achieve the first remission state, DAS28 < 2.6 [ Time Frame: Up to 12 months ]
  16. Number of Adverse Events (AE) [ Time Frame: Up to 12 months ]
  17. Number of Serious Adverse Events (SAE) [ Time Frame: Up to 12 months ]
  18. Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Up to 12 months ]
  19. Existence or the absence of radiographic erosions as determined by the investigator by imaging technique [ Time Frame: At baseline ]
  20. Existence or the absence of radiographic erosions as determined by the investigator by imaging technique [ Time Frame: Up to 12 months ]
  21. Rheumatoid factor (RF) [ Time Frame: Up to 12 months ]
  22. Patient global assessment (PGA) [ Time Frame: Up to 12 months ]
  23. Evaluator global assessment (EGA) [ Time Frame: Up to 12 months ]
  24. Clinical disease activity index (CDAI) [ Time Frame: Up to 12 months ]
  25. Simple disease activity index (SDAI) [ Time Frame: Up to 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The participant population targeted in this study consists of participants with early-stage RA (i.e. diagnosis of RA not longer than 24 months) that initiate treatment with Abatacept.
Criteria

Inclusion Criteria:

  • Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA
  • Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics)

Exclusion Criteria:

  • Participants who are currently included in any interventional clinical trial in RA

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): NCT03457792


Contacts
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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
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Germany
Local Institution Recruiting
Freiburg im Breisgau, Germany, 79095
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03457792     History of Changes
Other Study ID Numbers: IM101-679
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Connective Tissue Diseases
Abatacept
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents