T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01060098
• Date of registration: 29/01/2010
• Prospective Registration: Yes
• Primary sponsor: Imperial College London
• Public title: T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade
• Scientific title: T Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha Agents
• Date of first enrolment: April 2010
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01060098
• Study type: Observational

Countries of recruitment

United Kingdom

Contacts

• Name: Sonya Abraham
• Affiliation: Imperial College London

Key inclusion & exclusion criteria

Inclusion criteria:

- Only anti-TNF naïve patients will be included in this study

- Patients between 18 to 80 years of age

- Patients due to start treatment with anti-TNF blocking agents - etanercept or
adalimumab

Patients with rheumatoid arthritis

- Only patients meeting the 1987 American College of Rheumatology (ACR) revised
classification criteria for rheumatoid arthritis will be included

- Patients should have active rheumatoid arthritis, defined by an initial DAS28 score
>5.1

- Patients should have at least 1 joint suitable for synovial biopsy

- Patients can be on concurrent DMARDs but they should have been on a stable dose of
DMARD for at least 1 month prior to study entry

- Patients can be on a concurrent dose of glucocorticoids (up to 10mg daily) and they
should have been on a stable dose for at least 4 weeks prior to study entry

Patients with psoriatic arthritis

- Patients should have a secure diagnosis of psoriatic arthritis determined by a
rheumatologist

- Patients with psoriatic arthritis included in this study should have evidence of
concurrent psoriatic skin lesions at the time of study entry

- Patients should have at least one joint suitable for synovial biopsy

- Patients can be on concurrent DMARDs - they should be on a stable dose of DMARD for at
least 1 month prior to study entry

Patients with Ankylosing spondylitis

- Patient should fulfil the Modified New York Criteria for diagnosis of ankylosing
spondylitis

- Patients can be on concurrent NSAIDs

- Patients can be on concurrent DMARDs - they should be on a stable dose of DMARD for at
least 1 month prior to study entry

Exclusion Criteria:

- Patients who have been previously treated with anti-TNF therapy for whatever reason

- Patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who
do not fulfil the diagnostic criteria for these conditions as above

- Patient who have received an intra-articular injection of steroids or have received an
intra-muscular injection of depot steroid to treat disease flare in the preceding 4
weeks prior to commencing anti-TNF therapy.

- Patients with intercurrent, active infection of any type, excluding the common cold



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Ankylosing Spondylitis

Rheumatoid Arthritis

Intervention(s)

Drug: anti-TNF therapy (etanercept or adalimumab)

Primary Outcome(s)

Measurement of Effector T Helper Type 17 Cells in Peripheral Blood [Time Frame: Week 0, Week 12]

Secondary ID(s)

2104091

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01060098