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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

Tracking Information
First Submitted Date February 13, 2018
First Posted Date March 8, 2018
Last Update Posted Date April 3, 2018
Actual Study Start Date December 19, 2017
Estimated Primary Completion Date March 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2018)
Number of patients continuing with abatacept treatment [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03457792 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 6, 2018)
  • Anti-citrullinated protein antibody (ACPA) titer [ Time Frame: At baseline ]
  • Concomitant treatment given with abatacept as determined by the investigator [ Time Frame: Up to 12 months ]
  • Dosage of abatacept as determined by the investigator [ Time Frame: Up to 12 months ]
  • Frequency of administration of abatacept [ Time Frame: Up to 12 months ]
  • Reason for abatacept treatment initiation as determined by the investigator [ Time Frame: At baseline ]
  • Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD) [ Time Frame: Up to 12 months ]
  • Socio-demographics of participants as determined by the investigator [ Time Frame: At baseline ]
  • Disease history of participants as determined by the investigator [ Time Frame: At baseline ]
  • Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia) [ Time Frame: Up to 12 months ]
  • Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency) [ Time Frame: Up to 12 months ]
  • 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]
  • Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria [ Time Frame: Up to 12 months ]
  • Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2) [ Time Frame: Up to 12 months ]
  • Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2 [ Time Frame: Up to 12 months ]
  • Number of patients who achieve the first remission state, DAS28 < 2.6 [ Time Frame: Up to 12 months ]
  • Number of Adverse Events (AE) [ Time Frame: Up to 12 months ]
  • Number of Serious Adverse Events (SAE) [ Time Frame: Up to 12 months ]
  • Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Up to 12 months ]
  • Existence or the absence of radiographic erosions as determined by the investigator by imaging technique [ Time Frame: At baseline ]
  • Existence or the absence of radiographic erosions as determined by the investigator by imaging technique [ Time Frame: Up to 12 months ]
  • Rheumatoid factor (RF) [ Time Frame: Up to 12 months ]
  • Patient global assessment (PGA) [ Time Frame: Up to 12 months ]
  • Evaluator global assessment (EGA) [ Time Frame: Up to 12 months ]
  • Clinical disease activity index (CDAI) [ Time Frame: Up to 12 months ]
  • Simple disease activity index (SDAI) [ Time Frame: Up to 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis
Official Title Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Rheumatoid Arthritis
Intervention Drug: Abatacept
Subcutaneous (SC) or intravenous (IV) administration
Other Names:
  • Orencia
  • BMS-188667
Study Groups/Cohorts Abatacept for Rheumatoid Arthritis (RA)
Participants diagnosed with moderate to severe active RA within the last 24 months and initiated treatment with Abatacept
Intervention: Drug: Abatacept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 6, 2018)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 12, 2021
Estimated Primary Completion Date March 12, 2021   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
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 #.
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03457792
Other Study ID Numbers IM101-679
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2018