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

NCT01717846 | Withdrawn Phase 4

• 1 other identifier: IM101-356
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Apoptotic DNA Damage; Rheumatoid Arthritis; T-cell Lymphocytosis

Keywords

Apoptosos; Rheumatoid Arthritis; T cells, B cells; DAS28; Clinical Disease activity Index; CDAI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points

  Baseline, 3 and 6 months

Other Outcomes (1)

• To measure the change in clinical disease activity index between base line, at 3 months and 6 months time points.

  Baseline, 3 and 6 months

Study Arms (2)

Arm 1

EXPERIMENTAL

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.

Drug: Group 1 or Orencia treated group

Arm 2 or group 2

OTHER

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: Group 2 (DMARDS treated group)

Interventions

Group 1 or Orencia treated group DRUG

Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.

Also known as: Abatacept

Arm 1

Group 2 (DMARDS treated group) OTHER

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.

Also known as: Arm 2 or group 2

Arm 2 or group 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or breast feeding
• Previous exposure to abatacept.
• History of a concomitant autoimmune disease (eg. SLE, PsA etc.)
• Patients with history of cancer

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Univerity of California at Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Ram P Singh, MS, Ph.D.

  University of California at Los Angeles, UCLA

  PRINCIPAL INVESTIGATOR

• Mihaela Taylor, MD

  University of California at Los Angeles (UCLA)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 31, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

US (1)