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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Study design:   
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:     Sonya Abraham
Address: 
Telephone:
Email:
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
Ankylosing Spondylitis
Psoriatic Arthritis
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 Outcome(s)
Secondary ID(s)
2104091
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 02/01/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01060098
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