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Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis (RA)

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ClinicalTrials.gov Identifier: NCT01717846
Recruitment Status : Withdrawn (The PI has left UCLA and we do not plan to pursue this study.)
First Posted : October 31, 2012
Last Update Posted : May 11, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE October 24, 2012
First Posted Date  ICMJE October 31, 2012
Last Update Posted Date May 11, 2016
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
To measure the change in apoptosis of T cells, B cells and antigen presenting (APC) cells in Rheumatoid Arthritis between the baseline, 3 months and at 6 months time points [ Time Frame: Base line, 3 and 6 months ]
To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01717846 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points [ Time Frame: Baseline, 3 and 6 months ]
To measure the changes in disease activity score joint count (DAS28/ESR)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 30, 2012)
To measure the change in clinical disease activity index between base line, at 3 months and 6 months time points. [ Time Frame: Baseline, 3 and 6 months ]
To measure the Clinical Disease Activity Index (CDAI), and Health Assessment Questionnaire (HAQ)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis
Official Title  ICMJE In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis
Brief Summary This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.
Detailed Description

Orencia may regulate apoptosis and apoptosis related genes in vivo in rheumatoid arthritis (RA) patient's cells. To date, no studies have been performed to evaluate the effect of Orencia on apoptosis in RA patients.

Primary: To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.

Secondary: To evaluate the association between the changes in apoptosis to changes in disease activity measures (DAS28/ESR) over 6 months of treatment with subcutaneous injection of abatacept.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Apoptotic DNA Damage
  • Rheumatoid Arthritis
  • T-cell Lymphocytosis
Intervention  ICMJE
  • Drug: Group 1 or Orencia treated group
    Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.
    Other Name: Abatacept
  • Other: Group 2 (DMARDS treated group)
    Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept.
    Other Name: Arm 2 or group 2
Study Arms  ICMJE
  • Experimental: Arm 1
    Orencia Group is for RA patients who have not received any other biologic treatment, including abatacept previously, and whose doctor has determined that it is appropriate to treat their RA with Abatacept. If you are in Group 1, you will receive the study drug, Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form. Abatacept, given in an intravenous injection is approved by the FDA for the treatment of RA.
    Intervention: Drug: Group 1 or Orencia treated group
  • Arm 2 or group 2
    Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept.
    Intervention: Other: Group 2 (DMARDS treated group)
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  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 9, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2012)
24
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Over age 18
  2. Meeting ACR Criteria 1987 for RA diagnosis
  3. Naïve to treatment with abatacept
  4. Must be able to understand information in the Informed Consent

Exclusion Criteria:

  1. Pregnancy or breast feeding
  2. Previous exposure to abatacept.
  3. History of a concomitant autoimmune disease (eg. SLE, PsA etc.)
  4. Patients with history of cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01717846
Other Study ID Numbers  ICMJE IM101-356
IM101-356 ( Other Identifier: BMS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Ram P Singh, MS, Ph.D. University of California at Los Angeles, UCLA
Study Director: Mihaela Taylor, MD University of California at Los Angeles (UCLA)
PRS Account University of California, Los Angeles
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP