Trial Outcomes & Findings for Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept (NCT NCT02353780)

Results Overview

There will be no primary efficacy endpoints for the study. The primary endpoint of the study will be changes in frequencies of peripheral blood immune cell subsets following institution of a subcutaneously administered TNF antagonist, tocilizumab or abatacept. Flow ctyometry was performed on peripheral blood T cells to determine frequency of Th17/TfH cells based on cell surface markers.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

0 to 3 months

Results posted on

2020-10-01

Participant Flow

Out of 10 enrolled subjects, 9 subjects were randomized to one of three arms. One subject withdrew consent prior to being screened/randomized.

Participant milestones

Participant milestones
Measure	Different TNF Inhibitor The participant will be prescribed any TNF antagonist in this arm. The treating rheumatologist selects the TNF antagonist and the appropriate options for that therapy. TNF Antagonist (enbrel, humire, remicade, cimzia, symponi): TNF Antagonist; treating rheumatologist selects specifics for the therapy chosen.	Abatacept The participant will be prescribed abatacept in this arm. The treating rheumatologist selects the appropriate options for that therapy. Abatacept: Abatacept; SQ; specifics to be determined by the treating rheumatologist.	Tocilizumab The participant will be prescribed tocilizumab. The treating rheumatologist selects the appropriate options for that therapy. Tocilizumab: Tocilizumab; SQ; specifics determined by the treating rheumatologist.
Overall Study STARTED	3	3	3
Overall Study COMPLETED	3	3	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Different TNF Inhibitor n=3 Participants The participant will be prescribed any TNF antagonist in this arm. The treating rheumatologist selects the TNF antagonist and the appropriate options for that therapy. TNF Antagonist (enbrel, humire, remicade, cimzia, symponi): TNF Antagonist; treating rheumatologist selects specifics for the therapy chosen.	Abatacept n=3 Participants The participant will be prescribed abatacept in this arm. The treating rheumatologist selects the appropriate options for that therapy. Abatacept: Abatacept; SQ; specifics to be determined by the treating rheumatologist.	Tocilizumab n=3 Participants The participant will be prescribed tocilizumab. The treating rheumatologist selects the appropriate options for that therapy. Tocilizumab: Tocilizumab; SQ; specifics determined by the treating rheumatologist.	Total n=9 Participants Total of all reporting groups
Age, Continuous	44 years n=3 Participants	51 years n=3 Participants	52 years n=3 Participants	49 years n=9 Participants
Sex: Female, Male Female	3 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	7 Participants n=9 Participants
Sex: Female, Male Male	0 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	2 Participants n=9 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
CDAI	23 units on a scale n=3 Participants	17.3 units on a scale n=3 Participants	17.3 units on a scale n=3 Participants	19.2 units on a scale n=9 Participants

PRIMARY outcome

Timeframe: 0 to 3 months

Population: Patients (total of 5) who provided blood samples at 0 and 3 months and flow cytometry was performed before study discontinuation are included in the analysis.

There will be no primary efficacy endpoints for the study. The primary endpoint of the study will be changes in frequencies of peripheral blood immune cell subsets following institution of a subcutaneously administered TNF antagonist, tocilizumab or abatacept. Flow ctyometry was performed on peripheral blood T cells to determine frequency of Th17/TfH cells based on cell surface markers.

Outcome measures

Outcome measures
Measure	Different TNF Inhibitor n=2 Participants The participant will be prescribed any TNF antagonist in this arm. The treating rheumatologist selects the TNF antagonist and the appropriate options for that therapy. TNF Antagonist (enbrel, humire, remicade, cimzia, symponi): TNF Antagonist; treating rheumatologist selects specifics for the therapy chosen.	Abatacept n=1 Participants The participant will be prescribed abatacept in this arm. The treating rheumatologist selects the appropriate options for that therapy. Abatacept: Abatacept; SQ; specifics to be determined by the treating rheumatologist.	Tocilizumab n=2 Participants The participant will be prescribed tocilizumab. The treating rheumatologist selects the appropriate options for that therapy. Tocilizumab: Tocilizumab; SQ; specifics determined by the treating rheumatologist.
Mechanistic Comparisons (Changes in Frequencies of Peripheral Blood Immune Cell Subsets Following Institution of a Subcutaneously Administered TNF Antagonist, Tocilizumab or Abatacept.)	0.9 Th17/TfH cell subset % change Interval 0.38 to 1.46	2.9 Th17/TfH cell subset % change Interval 2.9 to 2.9	0.9 Th17/TfH cell subset % change Interval 0.7 to 1.1

SECONDARY outcome

Timeframe: 0 to 3 months

Population: CDAI change from 0 to 3 months was calculated for the 5 patients who had this data available.

Efficacy of therapy, as measured by number of participants with Clinical Disease Activity Index (CDAI) of less than 2.8 (remission). CDAI is a composite score of RA disease activity based on patient survey (up to 10 points), physician survey (up to 10 points), + number of swollen joints + number of tender joints. 0 = no disease, max score is 60, higher score = more severe disease. Number of patients achieving remission is reported.