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

Rheumatoid Arthritis Clinical Trial

— RA  

Official title:

In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01717846
• Other study ID #: IM101-356
• Secondary ID: IM101-356
• Status: Withdrawn
• Phase: Phase 4
• First received: October 24, 2012
• Last updated: May 9, 2016
• Start date: December 2012
• Est. completion date: November 2014

Study information

• Verified date: May 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apoptotic DNA Damage
• Arthritis
• Arthritis, Rheumatoid
• Lymphocytosis
• Rheumatoid Arthritis
• T-cell Lymphocytosis

Intervention

Drug:
• Group 1 or Orencia treated group
Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.

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.

Locations

Country	Name	City	State
United States	Univerity of California at Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To measure the change in clinical disease activity index between base line, at 3 months and 6 months time points.	To measure the Clinical Disease Activity Index (CDAI), and Health Assessment Questionnaire (HAQ)	Baseline, 3 and 6 months	Yes
Primary	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	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.	Base line, 3 and 6 months	No
Secondary	To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points	To measure the changes in disease activity score joint count (DAS28/ESR)	Baseline, 3 and 6 months	Yes