Trial Outcomes & Findings for T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade (NCT NCT01060098)

Results Overview

The frequency of circulating Th17 cells was determined by IL17 enzyme-linked immunospot assay (Elispot) and flow cytometry (fluorescence-activated cell sorting (FACS)).

Recruitment status

COMPLETED

Target enrollment

48 participants

Primary outcome timeframe

Week 0, Week 12

Results posted on

2020-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Rheumatoid Arthritis Participants with Rheumatoid arthritis anti-TNF therapy (etanercept or adalimumab): Biological DMARD	Ankylosing Spondylitis Participants with Ankylosing spondylitis	Psoriatic Arthritis Participants with Psoriatic arthritis
Overall Study STARTED	25	15	8
Overall Study COMPLETED	25	15	8
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	Rheumatoid Arthritis n=25 Participants Participants with Rheumatoid arthritis	Ankylosing Spondylitis n=15 Participants Participants with Ankylosing spondylitis	Psoriatic Arthritis n=8 Participants Participants with psoriatic arthritis	Total n=48 Participants Total of all reporting groups
Age, Continuous	57.4 years STANDARD_DEVIATION 11.7 • n=25 Participants	36.4 years STANDARD_DEVIATION 11.8 • n=15 Participants	50.9 years STANDARD_DEVIATION 8.4 • n=8 Participants	48.23 years STANDARD_DEVIATION 10.6 • n=48 Participants
Sex: Female, Male Female	18 Participants n=25 Participants	3 Participants n=15 Participants	5 Participants n=8 Participants	26 Participants n=48 Participants
Sex: Female, Male Male	7 Participants n=25 Participants	12 Participants n=15 Participants	3 Participants n=8 Participants	22 Participants n=48 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	25 participants n=25 Participants	15 participants n=15 Participants	8 participants n=8 Participants	48 participants n=48 Participants

PRIMARY outcome

Timeframe: Week 0, Week 12

Population: Patients with RA were studied at protocol visits during the initial 12 weeks of anti-TNF treatment

The frequency of circulating Th17 cells was determined by IL17 enzyme-linked immunospot assay (Elispot) and flow cytometry (fluorescence-activated cell sorting (FACS)).

Outcome measures

Outcome measures
Measure	Rheumatoid Arthritis n=25 Participants Participants with Rheumatoid arthritis	Ankylosing Spondylitis n=15 Participants Participants with Ankylosing spondylitis	Psoriatic Arthritis n=8 Participants Participants with Psoriatic arthritis
Measurement of Effector T Helper Type 17 Cells in Peripheral Blood Week 0	466.4 spSFC/10^6 Standard Error 277.6	432 spSFC/10^6 Standard Error 474	450 spSFC/10^6 Standard Error 276
Measurement of Effector T Helper Type 17 Cells in Peripheral Blood Week 12	759.8 spSFC/10^6 Standard Error 510	651 spSFC/10^6 Standard Error 532	609 spSFC/10^6 Standard Error 373

Adverse Events

Rheumatoid Arthritis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ankylosing Spondylitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Psoriatic Arthritis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sonya Abraham

Imperial College London

Phone: +44 (0)20 3313 4114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place